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AmB-(TICE)-Carboplatin-Etoposide

Description: Chemotherapy Protocol GERM CELL Amb TICE (Part 2): Carboplatin – Etoposide phosphate Ambulatory Regimen This regimen is for AMBULATORY CARE pathway use only use only and will only be available to prescribe at units which carry out autograft transplantation. This treatment regimen consists of two parts: 2 cycles of TI (Paclitaxel and Ifosfamide) followed by 3 cycles of CE (Carboplatin and Etoposide) with PBSC autologous transplant. Regimen • Germ Cell – Amb TICE (part 2): Carboplatin and Etoposide phosphate Indication • Conditioning for autologous peripheral blood stem cell transplant (PBSCT) / bone marrow transplant in individuals with relapsed and refractory metastatic germ cell tumours. Toxicity Drug Carboplatin Etoposide Adverse Effect Neuropathy, hypersensitivity, nephrotoxicity, ototoxicity Hypotension on rapid infusion, hyperbilirubinaemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • EDTA or calculated creatinine clearance before the 1st cycle. • FBC, LFTs and U&Es prior to each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.0 (December 2025) Page 1 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Treatment will be given regardless of blood results. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used. Hepatic Impairment Drug Carboplatin Bilirubin µmol/L AST/ALT units Dose (%of original dose) No adjustment necessary Etoposide (as 26-51 or etoposide phosphate) more than 51 or 60-180 more than 180 50 clinical decision Renal Impairment Drug Carboplatin Creatinine Clearance Dose (ml/min) (% of original dose) Less than 50 Do not use Changes in the GFR of more than 10% between cycles may require dose adjustment more than 50 100 Etoposide (as 15-50 75 etoposide phosphate) less than 15 50 Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Regimen The starting dose of carboplatin AUC8 is maxed at 1200mg; unless GFR is measured using EDTA and patient is over 18 in which case dose can exceed 1200mg after consultant review (ref NCI/CTEP letter Ivy et al 2010) Etoposide phosphate (Etopophos) must be used for this protocol as solutions of conventional etoposide would exceed the maximum concentration of 0.4 mg/mL and may precipitate. Version 1.0 (December 2025) Page 2 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate NOTE: 1 mg of etoposide = 1.136 mg etopophos (etoposide phosphate). Doses in this protocol are expressed as etoposide whereas all administration details in this protocol refer to Etoposide phosphate. Consider a dose reduction in poor performance patients. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. 21 day cycle for 3 cycles Drug Carboplatin Dose AUC8 Days -5, -4, -3 Administration Intravenous infusion in 500ml glucose 5% over 60 minutes Etoposide (as etoposide phosphate) 400mg/m2 -5, -4, -3 Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Dose Information • Carboplatin will be dose banded according to the national dose band (10mg/ml) • Etoposide dose will be rounded to the nearest 100mg (up if halfway) Administration Information Extravasation • Carboplatin – irritant • Etoposide - irritant Additional Therapy This regimen is to be administered in the ambulatory setting. Please ensure all supportive and take-home medicines are prescribed on the in-patient chart or general electronic prescribing system if patient requires admission. Please refer to the transplant schedule for each individual patient. This therapy may lead to the development of tumour lysis syndrome at the start of therapy. Patients should be assessed and for those patients deemed high risk allopurinol should be prescribed. This should begin the day before chemotherapy treatment and continue for as long as a significant chemo-sensitive tumour bulk remains. • Antiemetics - Starting 15-30 minutes prior to chemotherapy: Aprepitant 125mg once only orally on the day -5 then 80mg once a day for the subsequent two days - dexamethasone 2mg twice a day for 3 days oral or intravenous starting on day -5 of the cycle Version 1.0 (December 2025) Page 3 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate - metoclopramide 10mg three times a day for 10 days oral or intravenous starting on day -5 of the cycle - ondansetron 8mg twice a day oral or intravenous • Anti-infectives - aciclovir 400mg oral twice a day - ciprofloxacin 250mg oral twice a day from day +1 (stop when neutrophils are greater than 1) - fluconazole 100mg once a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) - nystatin suspension 1ml four times a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) • Thromboprophylaxis, to be started on Day +5, unless patient has been deemed high risk. To be continued until platelets are less than 50x109/L, or as directed by the consultant, according to VTE risk assessment and local formulary choices: - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection - Anti-embolism (TED) stockings • Growth factors such as filgrastim biosimilar 30million units (300mcg) once a day subcutaneous from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours, or greater than 3 on any occasion). This will not be supplied pre-admission, and to be prescribed on admission day +5. • Hormone replacement In menstruating women consider norethisterone 5mg three times a day oral to prevent menstruation. This may be stopped when the platelets are more than 50x109/L. • Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines. • Gastric protection with a proton pump inhibitor or a H2 antagonist according to local formulary choice: - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral • Hydration Encourage 2L oral fluids daily. If ambulatory patients are unable to maintain this (e.g. due to nausea), they should be admitted for intravenous hydration. Version 1.0 (December 2025) Page 4 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate Additional Information • Irradiated blood products must be used • Autologous stem cells/ bone marrow will be infused on day 0 References 1. Mummaneni, V., Kaul, S., Igwemezie, L.N. et al. Bioequivalence assessment of etoposide phosphate and etoposide using pharmacodynamic and traditional pharmacokinetic parameters. Journal of Pharmacokinetics and Biopharmaceutics 24, 313–325 (1996). https://doi.org/10.1007/BF02353515 2. Neon Healthcare Ltd. Etopophos 100mg Powder for Solution for Injection Summary of Product Characteristics. Electronic Medicines Compendium [Internet]. 2024. Available from: Etopophos 100 mg Powder for Solution for Injection - Summary of Product Characteristics (SmPC) - (emc) | 10514 3. Cancer Institute NSW – eviQ. Chemotherapy protocol: Autologous conditioning germ cell tumour TICE (cARBOplatin and etoposide) (part 2). [Internet]. 2011. Last reviewed 2022. Available from: 1178-Autologous conditioning germ cell tumour TICE (cARBOplatin and etoposide) (part 2) | eviQ Version 1.0 (December 2025) Page 5 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate REGIMEN SUMMARY Germ Cell – Amb TICE (part 2): Carboplatin and Etoposide phosphate Day -5 1. Aprepitant 125mg capsule oral 2. Dexamethasone 2mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Metoclopramide 10mg oral or intravenous 5. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 6. Carboplatin AUC8 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 1200mg based on a creatinine clearance of 125ml/min. 7. Etoposide 400mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions Etoposide phosphate (Etopophos) must be used for this protocol as solutions of conventional etoposide would exceed the maximum concentration of 0.4 mg/mL and may precipitate. 8. Sodium chloride 0.9% 1000ml intravenous infusion over 4 hours Take Home Medicines 9. Dexamethasone 2mg once a day in the afternoon for 3 days starting on day -5 10. Ondansetron 8mg once a day in the evening for 3 days starting on day -5, then take 8mg twice a day for 3 days. 11. Metoclopramide 10mg twice a day in the afternoon and evening for 3 days starting on day -5, then take 10mg three times a day for 3 days. Administration instructions –Please supply 28 tablets or an original pack as appropriate 12. Aciclovir 400mg three times a day for 28 days Administration Instructions Please supply 28 days or an original pack if appropriate. 13. Ciprofloxacin 250mg twice a day starting on day +1 Administration Instructions: Stop when neutrophils are greater than 1.0. Please supply 14 days with no stop date 14. Fluconazole 100mg oral once a day Administration instructions – stop when neutrophils are greater than 1.0 unless the patient remains on corticosteroids. Please supply 14 days with no stop date. 15. Nystatin 1ml four times a day Administration instructions – stop when neutrophils are greater than 1.0 unless the patient remains on corticosteroids. Please supply 1 x OP Version 1.0 (December 2025) Page 6 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate 16. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 17. Sodium Chloride 0.9% oral rinse 10mL four times a day Administration instructions – pharmacy please supply 50 x 10mL pods 18. Thromboprophylaxis according to local formulary choice To start on admission, on Day +5, unless the patient is deemed high risk. Continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices: - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 28 days or nearest original pack size. 19. Warning – Ensure take home medicines are supplied Day -4, day -3 20. Aprepitant 80mg once a day oral 21. Dexamethasone 2mg oral or intravenous 22. Ondansetron 8mg oral or intravenous 23. Metoclopramide 10mg oral or intravenous 24. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 25. Carboplatin AUC8 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 1200mg based on a creatinine clearance of 125ml/min. 26. Etoposide 400mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions Etoposide phosphate (Etopophos) must be used for this protocol as solutions of conventional etoposide would exceed the maximum concentration of 0.4 mg/mL and may precipitate. 27. Sodium chloride 0.9% 1000ml intravenous infusion over 4 hours Version 1.0 (December 2025) Page 7 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate Day -2, Day -1 Rest day Day 0 28. Chlorphenamine 10mg Intravenous bolus Administration instructions – to be given pre stem cell infusion 29. Paracetamol 1000mg Tablet Oral Administration instructions – to be given pre stem cell infusion 30. Stem Cell Return – see separate chart Version Date 1 09/12/2025 DOCUMENT CONTROL Amendment None Written By Alexandre Guedes Pharmacist Approved By Robert Lown Consultant This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; University Hospital Southampton NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.0 (December 2025) Page 8 of 8 Germ Cell – Amb TICE (part 2): Carboplatin (AUC 8) and Etoposide phosphate
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Germcell/AmB-TICE-Carboplatin-Etoposide.pdf

Lumbar puncture - patient information

Description: This factsheet explains what a lumbar puncture is and what the procedure involves, so you know what to expect.
Url: /Media/UHS-website-2019/Patientinformation/Brain-and-spine/Lumbar-puncture-2048-PIL.pdf

Pain relief at home - patient information

Description: This factsheet explains the different types of pain relief medications you may be prescribed and their common side effects.
Url: /Media/UHS-website-2019/Patientinformation/Surgery/Pain-relief-at-home-2940-PIL.pdf

Carboplatin-Vinorelbine Oral

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) CARBOPLATIN (AUC6)-VINORELBINE (Oral) Regimen  NSCLC – Carboplatin (AUC6)-Vinorelbine (Oral) Indication  First line therapy of stage III or IV NSCLC  WHO Performance status 0, 1, 2  Palliative intent Toxicity Drug Carboplatin Vinorelbine Adverse Effect Neuropathy, thrombocytopenia Neuropathy, stomatitis, transient elevation of LFTs, pain, constipation The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease  A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen  EDTA or calculated creatinine clearance before the first cycle  FBC, LFTs and U&Es prior to each cycle  A chest x-ray should be performed before each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. Version 1.3 (May 2023) Page 1 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Prior to prescribing cycle one the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level Greater than or equal to 1.5x109/L (unless due to bone marrow impairment) Greater than or equal to 100x109/L (unless due to bone marrow impairment Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L, then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L, then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Dose adjustments for day eight should be made according to local practice guidelines or procedures. Hepatic Impairment Drug Carboplatin Vinorelbine Recommendation No dose reduction necessary For the intravenous preparation consider a dose reduction to 20mg/m2 in severe liver impairment For the oral preparation consider a dose of 50mg/m2/week in moderate liver impairment Version 1.3 (May 2023) Page 2 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO Renal Impairment Drug Carboplatin Vinorelbine Dose (% of original dose) Significant changes in GFR (of more than 10%) may require dose adjustment Do not administer if the CrCl is less than 20ml/min No dose adjustment is necessary Regimen The starting dose of carboplatin AUC6 is used with calculated GFR. AUC5 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC6 is 900mg. This will be set as 890mg in ARIA to comply with national dose bands. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. The maximum dose of oral vinorelbine is 120mg for the 60mg/m2 dose and 160mg for the 80mg/m2 dose. The capsules are available in 20mg and 30mg strengths. It must be clear to all professionals and patients taking this treatment that it is a short term therapy that must not be supplied from primary care. 21 day cycle for 4 cycles Drug Dose Days Administration Carboplatin Vinorelbine AUC6 60mg/m2 (max dose 120mg) 1 Intravenous infusion in 500ml glucose 5% over 60 minutes 1, 8 Oral From cycle two onwards consider increasing the dose of vinorelbine (oral) to 80mg/m2 (maximum dose 160mg). Dose Information  Carboplatin will be dose banded in accordance with national dose bands (10mg/ml)  The maximum dose will be set at 890mg to comply with national dose bands  Vinorelbine (oral) will be rounded to the nearest 20mg (up if halfway) Version 1.3 (May 2023) Page 3 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO Administration Information Extravasation  Carboplatin – irritant Other  Oral vinorelbine capsules must be swallowed whole with food without chewing, sucking or dissolving the capsule. Additional Therapy  Antiemetics 15-30 minutes prior to chemotherapy on day one only; - ondansetron 8mg oral or intravenous - dexamethasone 8mg oral or intravenous As take home medication; - dexamethasone 4mg twice a day oral for 3 days - metoclopramide 10mg three times a day when required 15 – 30 minutes prior to chemotherapy on day eight only; - metoclopramide 10mg oral  Gastric protection with PPI or H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed  Prophylactic antibiotics can be considered if required Additional Information  The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to vinorelbine. References 1.National Institute of Clinical Excellence (2005). CG24. The Diagnosis and Treatment of Lung Cancer. Methods, Evidence and Guidance. DOH: London. 2.Schiller JH, Harrington D, Belani CP et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med 2002; 346 (2): 92-98. 3.Helbekkmo N, Sundstrom SH, Aasebo U et al. Vinorelbine/carboplatin vs gemcitabine/carboplatin in advanced NSCLC, similar efficacy but different impact on toxicity. Br J Cancer 2007; 97 (3): 283-289. 4.Jensen LH, Osterlind K, Rytter C et al. Randomised cross over study of patient preference for oral or intravenous vinorelbine in combination with carboplatinin the treatment of advanced non-small cell lung cancer. Lung Cancer 2008; 62 (1): 85-91. Version 1.3 (May 2023) Page 4 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO REGIMEN SUMMARY Carboplatin (AUC6)-Vinorelbine PO Day One 1. Dexamethasone 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. Administer dexamethasone 8mg intravenous or equivalent if required 2. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. Administer ondansetron 8mg intravenous if required 2. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration instructions: The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 6 is 900mg. The national dose bands do not contain this dose so the cap has been set at 890mg in ARIA. Please check this dose is appropriate for your patient. 4. Vinorelbine 60mg/m2 oral Administration instructions: Vinorelbine capsules should be taken with or after food, swallowed whole, not chewed. Oral SACT Take Home Medicines 5. Dexamethasone 4mg twice a day oral for 3 days starting on day two of the cycle Administration Instructions Take 4mg twice a day for 3 days starting on day 2 of the cycle 6. Metoclopramide 10mg three times a day when required oral Administration Instructions When required for the relief of nausea. Please supply five days or an original pack as appropriate. Day Eight 8. Metoclopramide 10mg oral Administration Instructions Administer 15-30 minutes before oral SACT 9. Vinorelbine 60mg/m2 oral Administration instructions: Vinorelbine capsules should be taken with or after food, swallowed whole, not chewed. Oral SACT Version 1.3 (May 2023) Page 5 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.3 May 2023 Carboplatin changed to national Alexandra Pritchard Tom Hurst dose bands Pharmacist Pharmacy Technician Administration instructions added to regimen summary Coding removed Maximum dose of carboplatin amended. 1.2 9th Jan Header changed to NHS badge Dr Deborah Wright Donna Kimber 2014 AUC6 added to name and “and” Pharmacist Pharmacy Technician replaced with dash Adverse effects put in table and toxicity removed > and < written in full Dose modification tabulated Renal and hepatic function tabulated. Vinorelbine information updated from SPC Carboplatin paragraph amended under regimen Regimen tabulated Twice daily now twice a day Bolus removed from injection Regimen name added to summary Summary re-numbered Metoclopramide dose changed to 10mg Starting on day two of the cycle added to dexamethasone Document control tabulated Hospital representation and disclaimer added 1.1 23rd Sept Font changed to Arial Dr Deborah Wright Donna Kimber 2010 Header altered to include Pharmacist Pharmacy Technician “Strength through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not Version 1.3 (May 2023) Page 6 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO information) changed Dose information added to reflect super user agreements Granisetron removed from antiemetics Coding added Summary page added This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.3 (May 2023) Page 7 of 7 NSCLC – Carboplatin (AUC 6)-Vinorelbine PO
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Carboplatin-Vinorelbine-Oral.pdf

Carboplatin(AUC6)-Pemetrexed

Description: Chemotherapy Protocol MESOTHELIOMA CARBOPLATIN (AUC6)-PEMETREXED Regimen • Mesothelioma – Carboplatin (AUC6)-Pemetrexed Indication • First line therapy of advanced pleural mesothelioma where the disease is not suitable for surgical resection • WHO Performance status 0, 1 • Palliative intent Toxicity Drug Carboplatin Adverse Effect Neuropathy, thrombocytopenia Pemetrexed Diarrhoea, skin reactions, neuropathy The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease • A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen • FBC, LFTs and U&Es before each cycle • A chest x-ray should be performed before each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule Version 1.5 (Feb 2023) Page 1 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Prior to prescribing cycle one the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level Greater than or equal to 1.5x109/L (unless due to bone marrow impairment) Greater than or equal to 100x109/L (unless due to bone marrow impairment Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL Subsequently if the neutrophils are less than 1.5 x109/L then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Hepatic Impairment Drug Carboplatin Pemetrexed Recommendation No dose reduction necessary Clinical decision Renal Impairment Drug Carboplatin Pemetrexed Dose (% of original dose) Significant changes in GFR (of more than 10%) may require dose adjustment Do not administer if the CrCl is less than 20ml/min If the creatinine clearance falls below 45ml/min consider dose reduction Version 1.5 (Feb 2023) Page 2 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed Regimen The starting dose of carboplatin AUC 6 is used with calculated GFR. AUC 5 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC5 is 900mg (creatinine clearance 125ml/min). This is not a dose included in the national dose banding table. The maximum dose has been set at 890mg in ARIA. Please check if this dose is appropriate. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle 21 day cycle for 3-6 cycles (6 cycles are set in Aria) Drug Dose Days Administration Carboplatin Pemetrexed AUC6 (max 890mg dose) 500mg/m2 1 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 100ml 1 glucose 5% or sodium chloride 0.9% over 10 minutes Dose Information • Carboplatin will be dose banded in accordance with the national dose bands (10mg/ml) • The maximum dose of carboplatin for AUC 6 is 900mg. This will be set as 890mg in ARIA to comply with national dose bands. • It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. • Pemetrexed will be dose banded in accordance with the national dose bands Administration Information • Carboplatin should be administered 30 minutes after the end of the pemetrexed infusion • Pemtrexed may be administered in 100ml of either glucose 5% or sodium chloride 0.9% over 10 minutes. The choice of fluid will be dependent on the product stocked by pharmacy. The fluid and volume will not appear in the prescription but can be located in the instructions notepad Version 1.5 (Feb 2023) Page 3 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed Extravasation • Carboplatin – irritant • Pemetrexed - inflammitant Additional Therapy • Folic acid 5mg once daily starting 1 – 2 weeks prior to and continuing for three weeks after the last dose of pemetrexed. • Hydroxocobalamin intramuscular injection 1mg every three months starting 1 – 2 weeks prior to pemetrexed. • Antiemetics 15-30 minutes prior to chemotherapy; - ondansetron 8mg oral or intravenous bolus Ensure the patient has taken oral dexamethasone starting the day before pemetrexed. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer an intravenous bolus dose of dexamethasone 20mg. As take home medication; - dexamethasone 4mg twice a day oral for 3 days starting the day before chemotherapy is due. - metoclopramide 10mg three times a day when required • Gastric protection with a proton pump inhibitor or H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed • Prophylactic antibiotics can be considered if required Additional Information • Consider draining pleural or peritoneal effusions prior to pemetrexed administration References 1.National Institute of Clinical Excellence (2009). TA135 Pemetrexed for the treatment of mesothelioma. London: DOH. 2.Santoro A, O’Brien ME, Stahel RA et al. Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: results of the International Expanded Access Programme. J Thorac Oncol 2008; 3 (7): 756 – 763. Version 1.5 (Feb 2023) Page 4 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed REGIMEN SUMMARY Carboplatin (AUC6)-Pemetrexed Cycle 1, 2, 3, 4, 5 Day Minus One 1. Dexamethasone 4mg twice a day oral* Day One 2. Dexamethsone 4mg twice a day oral (from TTO)* 3. Ondansetron 8mg oral or intravenous bolus Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as ondansetron 8mg IV stat if required. 4. Pemetrexed 500mg/m2 intravenous infusion in 100ml glucose 5% or sodium chloride 0.9% over 10 minutes 5. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes (start 30 minutes after the end of the pemetrexed infusion) Administration Instructions Start 30 minutes after the end of the pemetrexed infusion The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 6 is 900mg. The national dose bands do not contain this dose so the cap has been set at 890mg in ARIA. Please check this dose is appropriate for your patient. Take Home Medicines 6. Dexamethasone 4mg twice a day oral for 3 days starting the day before the pemetrexed infusion* 7. Metoclopramide 10mg three times a day when required oral Administration Instructions When required for the relief of nausea. Please supply five days or an original pack as appropriate 8. Folic acid 5mg once daily oral Cycle 6 Day Minus One 9. Dexamethasone 4mg twice a day oral* Day One 10. Dexamethsone 4mg twice a day oral (from TTO)* 11. Ondansetron 8mg oral or intravenous bolus Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as ondansetron 8mg IV stat if required Version 1.5 (Feb 2023) Page 5 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed 12. Pemetrexed 500mg/m2 intravenous infusion in 100ml glucose 5% or sodium chloride 0.9% over 10 minutes 13. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes (start 30 minutes after the end of the pemetrexed infusion) Administration Instructions Start 30 minutes after the end of the pemetrexed infusion The maximum dose of carboplatin at AUC 6 is 900mg (creatinine clearance 125ml/min). This has been set at 890mg in ARIA to comply with national dose bands Take Home Medicines 14. Metoclopramide 10mg three times a day when required oral Administration Instructions When required for the relief of nausea. Please supply five days or an original pack as appropriate 15. Folic acid 5mg once daily oral Hydroxocobalamin will not be included as part of the Aria regime and must be prescribed separately on the cycle for which it is due. * In Aria Planner the dexamethasone 4mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The patient should have been given the supply for cycle one in the pre-assessment or consent clinic. The administration instructions reflect this. Version 1.5 (Feb 2023) Page 6 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.5 Feb 2023 Max carboplatin dose added to Alexandra Pritchard Tom Hurst regimen table Pharmacist Pharmacy Technician 1.4 Aug 2022 Carboplatin national dose bands Dr Deborah Wright Donna Kimber added Pharmacist Pharmacy Technician 1.3 Jan 2016 Pemetrexed administration Dr Deborah Wright Donna Kimber changed throughout the text Pharmacist Pharmacy Technician 1.2 Header changed to NHS badge Dr Deborah Wright Debra Robertson AUC6 added to name and “and” Pharmacist Pharmacist replaced with dash Adverse effects put in table and toxicity removed Dose modification tabulated Renal and hepatic function tabulated Carboplatin paragraph amended under regimen Clarification added on the number of cycles set in Aria Regimen tabulated Twice daily changed to twice a day Regimen name added to summary Summary re-numbered Metoclopramide dose changed to 10mg Cycle 6 added with dexamethasone pre-medication removed Document control tabulated Hospital representation and disclaimer added 1.1 Sept 2010 Font changed to Arial Dr Deborah Wright Donna Kimber Header altered to include Pharmacist Pharmacy Technician “Strength through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Administration Information added Footer changed to include regimen name and review date removed Standard paragraph added to Version 1.5 (Feb 2023) Page 7 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed introduction in dose modifications Dose modifications format (not information changed) Dose information added to reflect super user agreements Granisetron removed from antiemetics Coding added Summary page added Document control added 1 Jan 2010 None Dr Deborah Wright Dr Andrew Bates Pharmacist Consultant Clinical Oncologist Dr Tim Gulliford Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.5 (Feb 2023) Page 8 of 8 Mesothelioma – Carboplatin (AUC6)-Pemetrexed
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Mesothelioma/CarboplatinAUC6-Pemetrexed-Ver1.5.pdf

Carboplatin and Pemetrexed

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) CARBOPLATIN-PEMETREXED Regimen • NSCLC – Carboplatin-Pemetrexed Indication • First line therapy of stage IIIB or IV adenocarcinoma or large cell carcinoma of the lung • WHO Performance status 0, 1 • Palliative intent Toxicity Drug Carboplatin Adverse Effect Neuropathy, thrombocytopenia Pemetrexed Diarrhoea, skin reactions, neuropathy The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease • A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen • FBC, LFTs and U&Es before each cycle • A chest x-ray should be performed before each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule Version 1.4 (February 2023) Page 1 of 8 NSCLC – Carboplatin-Pemetrexed for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Prior to prescribing cycle one the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level Greater than or equal to 1.5x109/L (unless due to bone marrow impairment) Greater than or equal to 100x109/L (unless due to bone marrow impairment Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL Subsequently, if the neutrophils are less than 1.5x109/L in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts still fall within this range continue using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction then stop treatment. If the platelets are less than 100x109/L, in the first instance, delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Hepatic Impairment Drug Carboplatin Pemetrexed Recommendation No dose reduction necessary Clinical decision Renal Impairment Drug Carboplatin Pemetrexed Dose (% of original dose) Significant changes in GFR (of more than 10%) may require dose adjustment Do not administer if the CrCl is less than 20ml/min If the creatinine clearance falls below 45ml/min consider dose reduction Version 1.4 (February 2023) Page 2 of 8 NSCLC – Carboplatin-Pemetrexed Regimen The starting dose of carboplatin AUC6 is used with calculated GFR. AUC5 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC6 is 900mg. This will be set as 890mg in ARIA to comply with national dose bands. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. 21 day cycle for 4 cycles Drug Dose Days Administration Carboplatin Pemetrexed AUC6 500mg/m2 1 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 100ml 1 glucose 5% or sodium chloride 0.9% over 10 minutes Dose Information • Carboplatin will be dose banded according to the national dose band (10mg/ml) • The maximum dose will be set at 890mg to comply with national dose bands • Pemetrexed will be dose banded in accordance with the national dose bands Administration Information • Carboplatin should be administered 30 minutes after the end of the pemetrexed infusion • Pemtrexed may be administered in 100ml of either glucose 5% or sodium chloride 0.9% over 10 minutes. The choice of fluid will be dependant on the product stocked by pharmacy. The fluid and volume will not appear in the prescription but can be located in the instructions notepad. Extravasation • Carboplatin – irritant • Pemetrexed - inflammitant Additional Therapy Version 1.4 (February 2023) Page 3 of 8 NSCLC – Carboplatin-Pemetrexed • Folic acid 5mg once daily starting 1 – 2 weeks prior to and continuing for three weeks after the last dose of pemetrexed. • Hydroxocobalamin intramuscular injection 1mg every three months starting 1 – 2 weeks prior to pemetrexed. • Antiemetics 15-30 minutes prior to chemotherapy; - ondansetron 8mg oral or intravenous Ensure the patient has taken the oral dexamethasone starting the day before pemetrexed. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg intravenous 15-30 minutes before chemotherapy. As take home medication; - dexamethasone 4mg twice a day oral for 3 days starting the day before chemotherapy is due. - metoclopramide 10mg three times a day when required • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed • Prophylactic antibiotics can be considered if required Additional Information • Consideration should be given to draining pleural or peritoneal effusions prior to pemetrexed administration References 1.National Institute of Clinical Excellence (2009). TA181 Pemetrexed for the first line treatment of non-small cell lung cancer. London: DOH. 2.Gronberg BH, Bremnes RM, Flotten O et al. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first line chemotherapy in advanced non-small cell lung cancer. J Clin Oncol 2009; 27 (19): 3217-3224. Version 1.4 (February 2023) Page 4 of 8 NSCLC – Carboplatin-Pemetrexed REGIMEN SUMMARY Carboplatin (AUC6)-Pemetrexed Cycle 1, 2, 3 Day Minus One 1. Dexamethasone 4mg twice a day oral* Day One 2. Dexamethsone 4mg twice a day oral (from TTO)* 3. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. Administer ondansetron 8mg intravenous if required 4. Pemetrexed 500mg/m2 intravenous infusion in 100ml glucose 5% or sodium chloride 0.9% over 10 minutes 5. Carboplatin AUC 6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions Start 30 minutes after the end of the pemetrexed infusion. The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 6 is 900mg. The national dose bands do not contain this dose so the cap has been set at 890mg in ARIA. Please check this dose is appropriate for your patient. Take Home Medicines 6. Dexamethasone 4mg twice a day oral for 3 days starting the day before the pemetrexed infusion* 7. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate 8. Folic acid 5mg once daily oral Cycle 4 Day Minus One 9. Dexamethasone 4mg twice a day oral* Day One 10. Dexamethsone 4mg twice a day oral (from TTO)* Version 1.4 (February 2023) Page 5 of 8 NSCLC – Carboplatin-Pemetrexed 11. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. Administer ondansetron 8mg intravenous if required 12. Pemetrexed 500mg/m2 intravenous infusion in 100ml glucose 5% or sodium chloride 0.9% over 10 minutes 13. Carboplatin AUC 6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions Start 30 minutes after the end of the pemetrexed infusion. Take Home Medicines 14. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate 15. Folic acid 5mg once daily oral Hydroxocobalamin will not be included as part of the Aria regime and must be prescribed separately on the cycle for which it is due. * In Aria Planner the dexamethasone 4mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The patient should have been given the supply for cycle one in the pre-assessment or consent clinic. The administration instructions reflect this. Version 1.4 (February 2023) Page 6 of 8 NSCLC – Carboplatin-Pemetrexed DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.4 Feb 2023 National dose banding for Alexandra Pritchard Tom Hurst carboplatin added Pharmacist Pharmacy Technician Maximum dose of carboplatin amended as per national dose bands Administration instructions added Coding removed 1.3 9th Jan Diluent for pemetrexed changed Dr Deborah Wright Donna Kimber 2016 throughout the text Pharmacist Pharmacy Technician 1.2 9th Jan Header changed to NHS badge Dr Deborah Wright Donna Kimber 2014 AUC6 added to name and “and” Pharmacist Pharmacy Technician replaced with dash Adverse effects put in table and toxicity removed Dose modification tabulated Renal and hepatic function tabulated Carboplatin paragraph amended under regimen Start after pemetrexed removed from carboplatin in regimen table Regimen tabulated Twice daily now twice a day Bolus removed from injection Regimen name added to summary Metoclopramide dose changed to 10mg Cycle 4 added with dexamethasone pre-medication removed Summary re-numbered Document control tabulated Hospital representation and disclaimer added 1.1 23rd Sept Font changed to Arial Dr Deborah Wright Donna Kimber 2010 Header altered to include Pharmacist Pharmacy Technician “Strength through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Version 1.4 (February 2023) Page 7 of 8 NSCLC – Carboplatin-Pemetrexed Administration Information added Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not information) changed Dose information added to reflect super user agreements Granisetron removed from antiemetics Coding added Summary page added Document control added This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.4 (February 2023) Page 8 of 8 NSCLC – Carboplatin-Pemetrexed
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Carboplatin-Pemetrexed-Ver1.4.pdf

Dietary advice for jejunocolic anastomosis - patient information

Description: This factsheet explains jejunocolic anastomosis and the dietary changes you may need to make because of this.
Url: /Media/UHS-website-2019/Patientinformation/Digestionandurinaryhealth/Dietary-advice-for-jejunocolic-anastomosis-3195-PIL.pdf

Annual-report-2017-18

Description: ANNUAL REPORT AND ACCOUNTS 2017/18 incorporating the quality account 2017/18 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 University Hospital Southampton NHS Foundation Trust Annual report and accounts 2017/18 incorporating the quality account 2017/18 Presented to Parliament pursuant to Schedule 7, paragraph 25 (4) (a) of the National Health Service Act 2006 3 ©2018 University Hospital Southampton NHS Foundation Trust 4 TABLE OF CONTENTS Overview and performance report Statement from the chairman and chief executive 7 Statement of purpose and activities 8 History of UHS 8 Structure of executive team 9 Structure of our services 10 Our vision and values 11 Priorities, key issues and risks 12 Going concern disclosure 15 Performance report 15 Regulatory body ratings 22 Environmental matters 23 Social, community and human rights issues 24 Accountability report Directors’ report – the Trust Board 26 Well-led framework 32 Audit and risk committee 32 Disclosures 35 Council of Governors 43 Annual remuneration statement 52 Remuneration and appointments committee 55 Governors’ nomination committee 57 Staffing report 61 Responding to the staff annual attitude survey 66 Statement of chief executive’s responsibilities as the accounting officer 71 Annual governance statement 72 Review of economy, efficiency and effectiveness of the use of resources 79 Equality, diversity and inclusion 83 Environmental sustainability and climate change 85 Southampton Hospital Charity 89 Developments in informatics 90 Leading research into better care 90 Investing for the future 91 Quality account and report Chief executive’s welcome 139 Our approach to quality assurance 141 Our commitment to safety 142 Our commitment to staff 143 Our commitment to education and training 145 Our commitment to technology to support quality 146 Our commitment to the Care Quality Commission 147 Review of quality performance 149 Progress against 2017/18 priorities 157 Clinical research 149 Review of services 150 CQUIN payment framework 150 Data quality 151 Clinical audits and confidential enquiries 152 Seven day hospital services 153 Learning from deaths 154 Priorities for improvement 2018/19 175 Conclusion 191 Responses to our quality account 192 Statement of directors’ responsibilities 198 Independent auditor’s report 199 Appendix Appendix one Quality improvement framework 2018/19 203 Appendix two Quality performance data 204 Appendix three CQUIN data 211 Appendix four Clinical audit and confidential enquiries data 214 Appendix five Registration with the Care Quality Commission 216 Appendix six Glossary of acronyms 217 Annual accounts Statement from the chief financial officer 93 Foreward to the accounts 94 Independent auditor’s report 95 Financial statements 101 5 OVERVIEW AND PERFORMANCE REPORT OVERVIEW AND PERFORMANCE REPORT A word from the chairman and chief executive Staff at UHS achieved some amazing things in 2017/18, a year in which the Trust faced the huge challenge of continuing to deal with rapidly rising demand for our services at a time when, like many hospitals, we were already under great pressure. Perhaps the most obvious achievement was that the Care Quality Commission (CQC) rated UHS as good for the quality of care which it provides overall and outstanding for leadership. It is no coincidence that the results from our latest NHS staff survey were so positive. We were particularly pleased that our response rate had increased and that UHS staff rated us the fourth best nationally for staff recommending the hospital as a place to work or receive care. We are also the seventh best nationally for staff engagement and results show that our staff feel able to contribute fully towards improvements. However, it’s truly in times of adversity, such as that we experienced over the winter period, that you see teamwork and commitment shine through. On several occasions we supported our neighbouring hospitals by providing care to their patients. We were also immensely proud of the way our staff pulled together during the days of thick snow with many staying on site overnight to ensure we had enough staff to care for our patients. Others stayed to look after stranded patients who were unable to get home. Staff with 4x4 vehicles collected colleagues for work and drove patients home. It was a monumental and incredibly uplifting effort from all. Our staff have indeed continued to strive tirelessly to provide both the quality of care and the speed of access to treatment to which we aspire. We are confident that we have done the former but the rapid increase in patient numbers has at times made it difficult to achieve the latter. We are determined to improve our performance to achieve the standards our patients expect. We are encouraged by the terrific results we achieve in the NHS Friends and Family test, with patients overwhelmingly recommending UHS as a place to have their hospital care. As the result of achieving our financial target for 2016/17 we became eligible for additional national cash incentive payments, which meant that in 2017/18 we were able to commit to the biggest capital investment programme the Trust has ever seen. As part of this programme we were able to address some of the areas of our estate that were highlighted as requiring improvement in a previous CQC report. We are delighted to say that we have again delivered our financial target for 2017/18 and will as a result be able to sustain a high rate of investment in upgrading our hospitals. We have also recently been able to start work on a £5m project to build a new Children’s Emergency Department as the result of generous support from the public for Southampton Hospital Charity and our partnership with the Murray Parish Trust without which the project would have been impossible. It will transform the environment in which our young patients are treated. Sadly at the end of the year we waved goodbye to Fiona Dalton, our chief executive for the last four years, who took the opportunity of a lifetime to live and work in Vancouver where she will lead a major Canadian healthcare group. Fiona was a remarkable chief executive, both immensely liked and admired throughout UHS and she left with the goodwill and best wishes of everyone. Peter Hollins David French Chairman Interim chief executive officer 7 OVERVIEW AND PERFORMANCE REPORT Overview of the Trust Statement of purpose and activities UHS is a large teaching hospital located on the south coast of England. We have a tripartite mission to provide clinical care, educate current and future healthcare professionals, and undertake research to improve healthcare for the future. Our clinical care encompasses local acute and elective care for 680,000 people who live in Southampton, the New Forest, Eastleigh and Test Valley. We also provide care for the residents of the Isle of Wight for many services. As the major university hospital on the south coast, UHS provides the full range of tertiary medical and surgical specialities (with the exception of transplantation, renal services and burns) to over 3.7 million people in central southern England and the Channel Islands. UHS is a centre of excellence for training the doctors, nurses and other healthcare professionals of the future. We work with the University of Southampton and Solent University to educate and develop staff at all levels, including a large apprenticeship programme, undergraduate and post-graduate education. Our role in research, developed in active partnership with the University of Southampton, is to contribute to the development of treatments for tomorrow’s patients. This work distinguishes us as a hospital that works at the leading edge of healthcare developments in the NHS and internationally. In particular we have nationally-leading research into cancer, respiratory disease, nutrition, cardiovascular disease, bone and joint conditions and complex immune system problems. We are one of the largest recruiters of patients into clinical trials in the country. Over 11,454 people work at the Trust, making it one of the area’s biggest employers. We also benefit from the contributions of over 1,000 volunteers. Our turnover in 2017/18 was more than £810m. History of UHS The Trust has its origins in the 1900s when the Shirley Warren Poor Law Infirmary was built on the site of what is now Southampton General Hospital. In the early half of the century, the site began to expand, including the opening of the school of nursing and the creation of the Wessex Neurological Unit. In 1971 a new medical school was opened in Southampton and the 1970s and 1980s saw a significant building programme encompassing the current footprint of Southampton General Hospital, Princess Anne Hospital and Countess Mountbatten House. During the 1990s, services were increasingly centralised at the general hospital, with the eye hospital and cancer services being relocated from elsewhere in the city. The Wellcome Trust funded a clinical research facility at the hospital in 2001 and this unit remains the foundation for much of the Trust’s groundbreaking medical research. In the last decade, development has continued with the opening of the North Wing Cardiac Centre in 2006, the creation of a major trauma centre with on-site helipad and the opening in 2014 of Ronald McDonald House for the relatives of sick children. Organisationally, Southampton University Hospitals Trust was formed in 1993, creating a single management board for acute services in Southampton. Eighteen years later, University Hospital Southampton NHS Foundation Trust (UHS) was formed (1 October 2011) when Southampton University Hospitals NHS Trust was licensed as a foundation trust by the then regulator, Monitor (now known as NHS Improvement (NHSI)). 8 OVERVIEW AND PERFORMANCE REPORT The way we’re structured Structure of the executive team Associate director of corporate affairs Amanda Lowe Constitution; Council of governors; legal services; insurance; risk management; policy management; freedom of information (FOI) general data protection regulations (GDPR) Chief executive (interim) David French Director of HR Steven Harris Employee relations; pay and reward; resourcing and temporary staffing; staff engagement; staff performance and appraisal; occupational health and wellbeing; childcare services Medical director Dr Derek Sandeman MD for research & development; clinical effectiveness; clinical practices and outcomes; professional regulation & standards; GP relationships Director of nursing & organisational development Gail Byrne Chief financial officer (interim) Paul Goddard Clinical governance & patient safety; education; patient experience; clinical practice & outcomes; professional regulation & standards; complaints/PALS; HR/workforce; voluntary services; fundraising Caldicott Guardian Financial management; financial strategy; investment & ROI; audit; procurement; capital programme management; estates; Commercial development Division A Surgery Cancer care Critical care & theatres Chief operating officer Caroline Marshall Major incident planning; security; communications Division B Division C Emergency medicine Women & newborn Specialist medicine/ ophthalmology Pathology Child health Support services Director of transformation & improvement Jane Hayward Division D Cardiovascular & thoracic Neurosciences Trauma & orthopaedics Cost improvement & transformation; information technology; information governance; core platform systems; informatics development; strategy; commissioning; business & capacity planning Senior Information Risk Owner (SIRO) Radiology 9 OVERVIEW AND PERFORMANCE REPORT Structure of our services Our services are split into five divisions and within each division there are care groups. Each division, with the exception of Trust headquarters, is led by a divisional management team consisting of: • divisional clinical director (DCD) • divisional director of operations (DDO) • divisional head of nursing/professions (DHN) • divisional research and development lead • divisional finance manager • divisional planning and business development (or strategy) manager • divisional education lead • division HR business partner • divisional governance manager (DGM) The diagram below outlines the five divisions and care groups/services within each. Each care group has a clinical lead, care group manager and matron/s for specific services as a minimum. Division A Surgery Cancer care Critical care Theatres Division B Emergency medicine Medicine for older people Pathology Specialist medicine and ophthalmology Genetics Division C Child health Women and newborn Support services Division D Cardiovascular and thoracic Neurosciences Trauma and orthopaedics Major trauma centre Radiology TRUST HQ Corporate affairs Communications Finance Human resources Informatics Patient support services Claims and litigation Cost improvement and transformation Estates and capital developments Research and development 10 OVERVIEW AND PERFORMANCE REPORT Our vision and values Our Forward vision outlines who we are and what we stand for, as well as describing the current challenges we face and our priorities for the future. It also provides an in-depth review of our three Trust values, which are summarised below: putting patien putting patien putting patien putting patien putting patien putting patien putting patien putting patien putting patien king together king together king together king together king together king together king together king together king together ts first ts firwsotr ts firwsotr wor ts first ts firwsotr ts firwsotr wor ts first ts firwsotr ts firwsotr wor always imparlwovaiynsg imparlwovaiynsg improving always imparlwovaiynsg imparlwovaiynsg improving always imparlwovaiynsg imparlwovaiynsg improving ts first ts first ts first wor wor wor putting patien putting patien putting patien king together king together king together always imparlwovaiynsg imparlwovaiynsg improving Patients and families will be at Our clinical teams will provide the heart of what we do and services to patients and are their experience within the crucial to our success. hospital, and their perception We have launched a leadership ofmtheeasTurruensgtop,aftwiesnuitlslcfbcnigreesptsaosti.euntrs fnigrsptatients first clsintrrikacintageltgomgyetahtnherkraianggtteoegmnetsehuernkrrintegstteoogaeumthresr are engaged in the day-to-day management and governance of the Trust. alw alw alw Our growing reputation in research and development and our approach to education and training will continue ays improtvoinagiyns icmoprropvionagrysaitmeprnoveinwg ideas, technologies and greater efficiencies in the services we provide tients first tients first tients first together together together mproving mproving mproving putti putting pa putti putting pa putti putting pa wo working wo working wo working always i always i always i 11 OVERVIEW AND PERFORMANCE REPORT Our priorities, key issues and risks Our top eight priorities 1 Promote and live our values. We will: • be clearer about the behaviours we expect from our staff • recruit, train and promote people who demonstrably share our values in everything they do 2 Improve safety, quality and productivity. We will: • Sign up to safety and deliver on our promises to patients as part of this campaign • Focus on improving outcomes by measuring and publishing clinical outcomes for all specialties • Focus on improving the whole patient experience, so that patients feel treated with compassion by all staff in every contact • Develop the concept of excellent administrative care, organising our services well so that the patient journey runs smoothly • Commit to productivity improvement across all areas • Develop innovative solutions that allow us to deliver services more efficiently while making better use of our capacity 3 Our staff and education mission. We will: • Attract the best staff by offering them a better deal and the best place to work • Continue to invest in education and training opportunities for our staff including leadership development • Ensure that our leaders and staff understand and deliver our equality and diversity agenda • Prioritise excellent communication that allows the voice of our staff to be heard and acted on • Focus on the staff of the future by developing our education and training capability for clinical and non-clinical staff • Work with our local education providers to offer excellent education opportunities and bring high calibre people into healthcare roles in our hospitals 4 Become a hospital without walls. We will: • Increase the number of patients we care for who are not inpatients within the hospital. Some of these will be cared for in another residential location or at home in partnership between ourselves and other organisations • Be clear about services where we wish to provide end-to-end integrated care, and those where we wish to work with partners to integrate care across organisations • Work with health and social care partners (public, private and third sector), where necessary using new organisational models, to ensure that patients are always cared for in the right setting • Work more closely with general practices and support innovation being led by primary care 12 OVERVIEW AND PERFORMANCE REPORT 5 Specialised services. We will: • Engage with commissioners to plan changes in service models according to national service specifications • Continue to plan and manage the ongoing drift of sub-specialist work particularly in paediatrics and complex surgical services • Maintain and develop the critical mass that is increasingly required to care for complex and specialist patients • Work with Salisbury NHS Foundation Trust, the University of Southampton and other partners to play our part in the genomic revolution, building on the Genomic Medicine Centre and seeking to become a Genomics Central Laboratory Hub for the region • Develop our clinical informatics ability to ensure that we can take advantage of new information available for the benefit of patients 6 Preventative care. We will: • Continue to expand our screening programmes as national policy and commissioning intentions develop • Take every opportunity to further support and improve the health of our staff • Ensure that our clinical translational research programme, much of which is directly relevant to health promotion, accelerates translation of research into benefit for the local population 7 Discovery. We will: • Develop a detailed plan to continue increasing the number of UHS patients who are offered access to clinical trials and maximise the impact of the research we undertake • Work with the University of Southampton to submit a strong bid for the next round of Biomedical Research Centre / Biomedical Research Unit funding opportunities • Support the University of Southampton to create an international centre for cancer immunology to accelerate the development of new immune therapies to treat cancer 8 All stages of life. We will: • Continue to expand our paediatric services in partnership with community and local acute paediatrics and develop the physical infrastructure of a modern children’s hospital as quickly as finances allow • Continue to improve transition and the care of teenagers and young adults • Develop elderly care services that are integrated across the acute and community sectors • Continue to develop our end of life care 13 OVERVIEW AND PERFORMANCE REPORT Key issues and risks 1 Failure to deliver national access targets, which impacts patient experience and patient safety. Whilst we are meeting some of the national constitutional standards in waiting times, we are not meeting them all. A number of actions have been taken in relation to improving responsiveness and working with local health and social care partners to reduce delayed transfers of care. The Trust will continue to work to reduce delayed transfers of care, as well as reviewing the efficiency of discharge processes during 2018/19. 2 Capacity and occupancy, which impacts on patient flow and the quality and timeliness of care. Operational risks have been identified across a number of services/specialties linking to issues around increasing referrals, system capacity and delayed transfers of care. We have mitigated this by implementing daily reviews to assess system capacity and escalation requirements aligning capacity plans with the wider system, developing plans to reduce length of stay with strong clinical leadership and oversight and working with local health and social care partners to reduce delayed transfers of care. 3 Staffing, both in terms of recruitment and retention. To mitigate this risk we will continue to focus on making UHS an attractive employer by: • developing band four posts and apprentices • leveraging the ‘Think UHS’ recruitment brand • continuing to recruit within Europe and further afield • working with universities to increase student nurses • enhancing medical overseas fellows posts • reviewing all junior doctor rotas in light of the new contract • using flexible and temporary staff when needed • creating different roles linked to our research agenda • reviewing training and education to enhance retention. 14 OVERVIEW AND PERFORMANCE REPORT Performance report Going concern disclosure After making enquiries, the directors have a reasonable expectation that the Trust has adequate resources to continue in operational existence for the foreseeable future. For this reason, they continue to adopt the going concern basis in preparing the accounts. Reporting structure As a large NHS university hospital foundation trust, UHS monitors performance within individual teams throughout the year with feedback processes in place to escalate issues to more senior management teams. At a corporate level we have an established executive reporting structure. Monthly Trust Board Public meeting where executive directors present high level summary to chairman and non-executive directors. For further information see page 30. Audit and risk committee Strategy and finance committee Quality committee Trust executive committee (TEC) Review performance/issues/risks in greater depth For further detail on role of these committees please refer to the annual governance statement section on page 72. Trust Board study sessions Trust Board members meet to focus on a specific issue. Performance meetings Operational management team (led by chief operating officer) and division and care group management teams focus on individual patient and service pathways to develop improvement plans. 15 OVERVIEW AND PERFORMANCE REPORT Key performance indicators (KPIs) The Trust publishes a monthly Integrated KPI Board Report on its website which provides both the Board and the public with an overview of performance within the Trust. This report is constantly evolving as new areas of monitoring are developed and new areas of national focus become apparent. For 2017/18 the format of the monthly report followed the five key Care Quality Commission (CQC) questions: • Are we safe? • Are we effective? • Are we caring? • Are we responsive? • Are we well-led? The monthly report features the following sections: • Executive digest – update on the previous month’s performance written by the director of transformation and improvement. • Trust overview – the top KPIs identified by Trust Board, RAG-rates for the previous 13 months • Safe • Effective • Caring • Activity • Emergency department (ED) • Referral to treatment (RTT/18 weeks) • Cancer waiting times • Flow • Staffing (HR) • Education and training • Research and development • Estates This report also includes summary versions of quarterly reports submitted to TEC which go into greater detail about patient experience, patient safety, clinical effectiveness and outcomes, and infection prevention. In addition, a separate Finance Board Report is submitted to Trust Board on a monthly basis. The emergency department, Activity and Flow section have several KPI’s that are relevant to the key risk of delivering the national access target. Some of the KPI’s are: • Number of attendances • Time to initial assessment • Hospital red/black alerts • Delayed transfers of care • Non-elective length of stay The Activity and Flow section have several KPI’s that are relevant to the key risk of capacity and occupancy. Some of the KPI’s are: • Length of stay • New referrals • Number of attendances • Bed occupancy • Hospital red/black alerts The Staffing (HR) section has several KPI’s that are relevant to the key risk of Staffing. Some of the KPI’s are: • Staff turnover • Nursing vacancies • Friends and Family Test – percentage of staff who recommend UHS as a place to work You can see full copies of the monthly report by visiting www.uhs.nhs.uk 16 OVERVIEW AND PERFORMANCE REPORT How we monitor performance In addition to reviewing the data submitted to the Trust Board in these papers, we have a suite of tools available to compare UHS performance to that of comparable trusts around the country. Depending on the measures being monitored, UHS has a number of peer groups to benchmark against including other local providers, major trauma centres and university hospital teaching trusts. Each NHS Trust will service a different size and type of population and will offer a slightly different range of services so it is important to understand that this benchmarking provides an initial indication of performance rather than an absolute guide to our position nationally. In 2017/18 we continue to review the National Model Hospital data as it is published from NHS Improvement. The data and ability to compare our performance has helped to highlight areas of excellent practice and areas where there is potential to improve. The Trust now has a model hospital steering group which identifies potential improvement projects from the data and reports to transformation board. Detailed analysis and explanation of the development and performance of UHS Activity, capacity and occupancy Over the past three years we have seen significant increases in all types of activity. This is linked to demographic growth, new specialist techniques and services transferring from other providers including vascular services from Portsmouth. In addition, UHS now has responsibility for surgical services at Lymington. The graph and table below demonstrate this increase in activity. UHS growth in activity – 2015/16 to 2017/18 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0 Inpatient spells (inc. day cases Outpatient appointments 2015/16 2016/17 2017/18 ED attendances (type one) Referrals Inpatient spells (inc. day cases Outpatient appointments ED attendances (type one) Referrals 2015/16 146,066 562,972 95,217 191,888 2016/17 155,780 596,621 99,493 204,840 2017/18 154,224 624,083 102,547 208,872 Increase 15/16 to 17/18 5.6% 10.9% 7.7% 8.9% 17 OVERVIEW AND PERFORMANCE REPORT Hospital alert status The hospital alert status is decided by the operations centre after assessing the bed and staffing position, and is recorded twice daily at the Trust bed meetings (though the status may change at any time). Black alert is the highest level of alert and is issued when there are no empty beds available across the Trust with no expected discharges, the emergency department is full, and if actions are not taken several ambulances are likely to be delayed for long periods of time, stopping them from responding to 999 calls (this is based on a national definition of escalation). Red alert is when the majority of the hospital is under significant operational pressure and is likely to include a mismatch between supply and demand of beds and/or there are no beds available, with patients waiting more than three hours in the emergency department, and patients with a clinical decision for admission but no bed identified for them to move to. The Trust will undertake a wide range of actions in response to this, including the opening of additional overnight beds (usually within day wards), the redistribution of staff or bed capacity to support areas under most pressure, Trust-wide communication to request a focus on actions which will enable patients to be discharged or the admission avoided and the potential review of less urgent elective operations to maintain bed availability for patients with more urgent needs. In 2015/16 a black alert was recorded seven times at the twice daily bed meetings. In 2016/17 this was increased to eleven and in 2017/18 this increased again to twenty. The chart below shows red and black alerts logged during 2017/18. 50 Number of AM and PM alerts 40 30 20 10 0 Mar 17 Apr 17 May 17 Jun 17 Jul 17 Aug 17 Sep 17 Oct 17 Nov 17 Dec 17 Jan 18 Feb 18 Mar 18 Red alerts Black alerts Contributing to this change has been an increase in length of stay (LoS) for elective patients linked to a more complex case mix and an increase in day cases. The chart below shows the total bed days attributable to delayed transfers of care at UHS in 2017/18. UHS delayed transfers of care 2017/18 Percentage of bed days lost 3,400 3,200 3,000 2,800 2,600 2,400 2,200 2,000 Mar 2017 April 2017 May 2017 June 2017 July 2017 Aug 2017 Sept 2017 Oct 2017 Nov 2017 Dec 2017 Jan 2018 Feb 2018 Mar 2018 18 OVERVIEW AND PERFORMANCE REPORT Referral to treatment (18 weeks) performance National target: 92% of all patients on 18 week pathway and not yet treated should have waited 18 weeks or less at the end of the month (incomplete pathways target). How did we do? UHS met the target in quarter one of 2017/18 but did not meet the target for the rest of the year. Achievement of this target in 2017/18 should be set against a rise in patient referrals, which highlights the increased demands being placed on the Trust. We have identified a reporting issue at our satellite outpatient clinics in Salisbury and are investigating the impact on referral to treatment reporting. Emergency department (ED) performance There are three types of emergency departments: Type Type Type ONE TWO THREE 3 24 hour with full resuscitation facilities 3 Consultant-led 3 Designated accommodation for patients admitted via ED 3 Single specialty emergencies (eye or dental) 3 Consultant-led 3 Designated accommodation 3 Minor injuries/walk-in centres 3 Doctor or nurse-led 3 Can be routinely accessed without appointment 3 May be co-located within an ED or sited in the community We run all three types of departments and, in August 2017 we also took over the operation of Lymington Minor Injuries Unit and opened the Urgent Care Hub at Southampton General in October 2017. All three types are subject to the national target and are therefore reflected in our figures. National target: The constitutional standard remains at 95% but a national recovery trajectory was agreed as: Patients should be treated and either admitted or discharged within four hours of arrival 85% achievement target set for April 17 90% achievement target in or before September 2017 95% achievement target by March 2018. How did we do? December 2017 was an extremely challenging month for emergency patients for the whole Hampshire and Isle of Wight area. UHS saw an increase in patients admitted to the Trust with influenza and, alongside our own bed pressures, we took ambulance diverts from other hospitals in order to maintain patient safety across Hampshire. Our Trust received formal letters of thanks from local commissioners and providers for the part we played during this difficult period. 19 OVERVIEW AND PERFORMANCE REPORT The graph below shows our performance against the four hour target over the last year. National 4 hour access target – UHS performance 100% 95% 89.4% 90% 85% 80% 87.4% 86.7% 91.4% 89.5% 93.3% 91.9% 90.5% 87.1% 83.2% 82.1% 82.5% 75% April 2017 May 2017 June 2017 July 2017 Aug 2017 Sept 2017 Oct 2017 Nov 2017 Dec 2017 Jan 2018 Feb 2018 Mar 2018 Cancer waiting times There are ten separate cancer waiting times measures (below) that the Trust reports to the Department of Health on a monthly basis, each of which can then be split into tumour site specific performance groups. In 2017/18 the Trust met six of these measures. Number Measures Achieved 1 a maximum one month (31-day) wait from the date a decision to treat (DTT) is made to the first definitive 8 treatment for all cancers 2 a maximum 31-day wait for subsequent treatment where the treatment is surgery 8 3 a maximum 31-day wait for subsequent treatment where the treatment is a course of radiotherapy 3 4 a maximum 31-day wait for subsequent treatment where the treatment is an anti-cancer drug regimen 3 5 a maximum two month (62-day) wait from urgent referral for suspected cancer to the first definitive 8 treatment for all cancers 6 a maximum 62-day wait from referral from an NHS cancer screening service to the first definitive treatment 3 for cancer 7 a maximum 62-day wait for the first definitive treatment following a consultant’s decision to upgrade the 3 priority of the patient (all cancers) 8 a maximum two-week wait to see a specialist for all patients referred with suspected cancer symptoms 3 9 a maximum two-week wait to see a specialist for all patients referred for investigation of breast symptoms, 8 even if cancer is not initially suspected 10 A maximum 31-day wait (urgent GP referral to treatment) for first treatment for rarer cancers 3 The number of patients referred under the two week wait urgent suspected cancer protocol seen within two weeks of their referral, rose by 5.2% in 2017/18. The chart overleaf shows the rise in demand for UHS cancer services over the past three years. 20 OVERVIEW AND PERFORMANCE REPORT UHS growth in cancer actvity – 2015/16 to 2017/18 20,000 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Two week waits 62 day target patients 2015/16 2016/17 2017/18 31 day target patients For staffing performance, please refer to page 61. For financial performance please see page 93. David French Interim chief executive officer 24 May 2018 21 OVERVIEW AND PERFORMANCE REPORT Regulatory body ratings Single Oversight Framework NHS Improvement’s Single Oversight Framework provides the framework for overseeing providers and identifying potential support needs. The framework looks at five themes: 1. Quality of care 2. Finance and use of resources 3. Operational performance 4. Strategic change 5. Leadership and improvement capability (well-led) Based on information from these themes, providers are segmented from one to four where ‘4’ reflects providers receiving the most support, and ‘1’ reflects providers with maximum autonomy. A foundation trust will only be in segments three or four where it has been found to be in breach or suspected breach of its licence. Segmentation During 2017/18 the Trust was confirmed as being placed within segment ‘2’. This segmentation information is the Trust’s position as at 31 March 2018. Current segmentation information for NHS trusts and foundation trusts is published on the NHS Improvement website. Finance and use of resources The finance and use of resources theme is based on the scoring of five measures from ‘1’ to ‘4’, where ‘1’ reflects the strongest performance. These scores are then weighted to give an overall score. Given that finance and use of resources is only one of the five themes feeding into the Single Oversight Framework, the segmentation of the Trust disclosed above might not be the same as the overall finance score here. Area Financial sustainability Financial sustainability Financial sustainability Overall scoring Care Quality Commission ratings: Metric Capital service cover Liquidity Income and expenditure margin Distance from financial plan Agency spend Q1 Q2 Q3 Q4 2 2 2 1 2 2 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 Overall rating for this trust Are services at this trust safe? Are services at this trust effective? Are services at this trust caring? Are services at this trust responsive? Are services at this trust well-led? Good Requires improvement Good Outstanding Requires improvement Outstanding 22 OVERVIEW AND PERFORMANCE REPORT The CQC inspected all key questions in four of the eight core services of surgery, critical care, end of life care and outpatient and diagnostic imaging and noted the Trust had a stable leadership team in place since their last inspection. The previous inspection in 2015 had found safety of medicine and maternity services, along with responsiveness of urgent and emergency care and children’s services ‘required improvement’. At the 2017 inspection the following observation was made: ‘At this inspection we saw significant improvement across the areas we inspected. There were improvements in surgery, critical care, end of life care and outpatients. Critical care is rated overall as ‘Outstanding’, with surgery, end of life care, and outpatients and diagnostic imaging as ‘Good’ overall. These services had been rated requires improvement in 2015. The improvements were in line with the trust’s improvement plan and had been assisted by the trust board and executive leadership team’ Professor Sir Mike Richards Chief Inspector of Hospitals Environmental matters We recognise that the Trust’s business has an impact on the environment. As a large hospital we undertake a wide range of activities and use a large amount of resources, for example: • The Trust generates approximately 3,000 tonnes of waste yearly, half of which is clinical waste. If not properly treated this huge amount of waste can cause soil, water and air pollution depending on the disposal route. • Due to the large number of visitors and deliveries we attract every day, traffic congestion is regularly experienced on and around the site, which impacts the air quality around the hospital. We are committed to environmental sustainability and consider it as part of the business culture. We acknowledge that reducing waste and minimising the consumption of scarce resources is consistent with financial sustainability. Our sustainability disclosure section on page 85 provides greater detail on the steps we are taking to reduce our activities’ impact on the environment. 23 OVERVIEW AND PERFORMANCE REPORT Social, community, anti-bribery and human rights issues We recognise our responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK), which are relevant to health and social care. These rights include the: • right to life • right not to be subjected to torture, inhuman or degrading treatment or punishment • right to liberty • right to respect for private and family life The Trust is committed to ensuring it fully takes into account all aspects of human rights in our work. At University Hospital Southampton we value our reputation for top quality care and financial probity and conduct our business in an ethical manner. The Bribery Act 2010 was introduced to make it easier to tackle the issue of bribery which is a damaging practice. Bribery can be defined as ‘giving someone a financial or other advantage to encourage them to perform their duties improperly or reward them for having done so’. To limit our exposure to bribery we have in place an Anti-Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Freedom to Speak Up (formerly Raising Concerns) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. We also employ a local counter fraud specialist who will investigate, as appropriate, any allegations of fraud, bribery or corruption. The success of our anti-bribery approach depends on our staff playing their part in helping to detect and eradicate bribery. Therefore, we encourage staff, service users and others associated with UHS to report any suspicions of bribery and we will rigorously investigate any allegations. In addition, we hold a register of interest for directors, staff, and governors and ask staff not to accept gifts or hospitality that will compromise them or the Trust. The Board of Directors carries out its business in an open and transparent way. We are committed to the prevention of bribery as well as to combating fraud and expect the organisations we work with to do the same. Doing business in this way enables us to reassure our patients, members and stakeholders that public funds are properly safeguarded. There are no important events since the year end affecting the foundation trust. No political donations have been made. The Trust has no overseas branches. 24 FR STAND BODY ACCOUNTABILITY REPORT Directors’ report – the Trust Board Board member Name Title Fiona Dalton Chief executive (until March 2018) David French Interim chief executive (chief financial officer until March 2018) Gail Byrne Director of nursing and organisational development Jane Hayward Director of transformation and improvement Biography Declarations Fiona was appointed as chief executive in 2013. Prior to re-joining the Trust she held the combined position of deputy chief executive and chief operating officer at Great Ormond Street Hospital for Children. Fiona joined the NHS management training scheme after graduating from Oxford University with a degree in human sciences and began her career in hospital management at Oxford Radcliffe Hospitals NHS Trust in 1996. She then spent four years at UHS as director of strategy and business development before moving to Great Ormond Street Hospital. NHS representative on Office for the Strategic Co-ordination of Health Research (OSCHR) Board; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a whollyowned subsidiary of UHSFT. David joined the Trust in February 2016 and led on finance, procurement, estates and commercial development until March 2018, when he became interim chief executive officer. He read Economics and Social Policy at the University of London before joining ICI plc, where he qualified as a chartered management accountant. David has extensive healthcare experience from the pharmaceutical industry, mostly Eli Lilly and Company where he held many commercial and financial roles in the UK and overseas. He joined the NHS in 2010 as chief financial officer of Hampshire Hospitals NHS Foundation Trust. He also serves as a non-executive director for Vivid Housing Limited, a social housing provider across Hampshire and the Solent. Non-executive director and chair of audit and risk committee, Vivid Housing Limited; Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Director, Southampton Commercial Estates Development Partnership (CEDP) Project Company Limited, a wholly-owned subsidiary of UHSFT; Member of Solent Acute Alliance Gail joined the Trust in 2010 as deputy director of nursing and head of patient safety. Prior to this, she has worked at the Strategic Health Authority as head of patient safety, and director of clinical services at Portsmouth Hospital. Gail has also worked in Brisbane, Australia as a hospital Macmillan nurse, and as general manager of a special purpose vehicle company for the private finance initiative at South Manchester Hospitals. Husband is a consultant surgeon in the Trust; Trustee of Naomi House Children’s Hospice (until 10 February Jane joined the Trust in 2000 as a clinical services manager for the cardiothoracic directorate after spending two years in Hertfordshire as director of performance and 11 years at Barts and the London Hospitals in various roles including planning, finance and commissioning. Jane has led on human resources, information management and technology, improvement and modernisation and has been chief operating officer. Jane joined the Trust Board in February 2008 and became director of transformation and improvement in January 2014. Director, UHS Estates Limited, a wholly-owned subsidiary of UHSFT; Father is mental health act manager, Southern Foundation Trust (voluntary position) (until 31 August 2017), member of assessment committee for Clinical Excellence Awards South and Public Health England (lay member) (until January 2018), a UHSFT simulated patient (voluntary position); Mother is a UHSFT simulated patient (voluntary position) Dr Derek Medical Sandeman director Dr Caroline Marshall Chief operating officer Derek was appointed to the Trust as a consultant physician in 1993 and went on to develop a regional endocrine service. Throughout his career he has had extensive clinical leadership experience, most recently serving eight years as clinical director. Derek’s leadership roles have also included programme director for postgraduate education and the Wessex Endocrine Royal College representative. He has a strong history of wider system engagement, working collaboratively with partners to improve systems resilience and pathways. Caroline joined the Trust in 1997 as a consultant hepatobiliary and neuroanaesthetist. She has held the posts of college tutor for the Royal College of Anaesthetists and UHS mentoring and coaching lead. In 2008, she became clinical service director for critical care, and then divisional clinical director for division A between 2010 and 2013. Caroline served as interim chief operating officer between January to December 2014, and was then appointed to the substantive post. Her portfolio includes the executive lead for cancer and the executive lead for major trauma. Director of UHS Pharmacy Limited, a wholly-owned subsidiary of UHSFT; Daughter-in-law employed at UHSFT as medical support to department of innovation (from January 2017 – December 2017) Daughter is in an administration role at UHS (from July 2017) 26 ACCOUNTABILITY REPORT Board member Name Title Biography Declarations Paul Goddard Interim chief financial officer (from April 2018) Paul joined the Trust in June 2007 as assistant director of finance and become the deputy director in December 2012. Paul has spent over 25 years in NHS finance having worked in many different organisations. A fellow of the Association of Chartered Certified Accountants, Paul became interim chief financial officer at UHS from April 2018. Serves as a director of the Trust’s wholly owned subsidiary company, UHS Pharmacy Limited. Sits on the Southampton Hospital Charity committee. Non-executive directors Peter Hollins Simon Porter Chair Senior independent director and deputy chair Peter graduated in chemistry from Hertford College, Oxford. Joining Imperial Chemical Industries in 1973, he undertook a series of increasingly senior roles in marketing and then general management. Following three years in the Netherlands as general manager of ICI Resins BV, he was appointed in 1992 as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, returning in 1998 to the UK as chief executive officer of British Energy where he remained until 2001. From 2001, he held various chairmanships and non-executive directorships. In 2003, he decided to return to an executive role as chief executive of the British Heart Foundation in which post he remained until retirement in March 2013. He joined Southampton University Hospital Trust as a nonexecutive director in 2010, became senior independent director and deputy chairman of UHS in 2014, and was appointed chair in April 2016. Partner in the Jubilee Film Partnership; Chair of CLIC Sargent Cancer Care for Children (a company limited by guarantee); Council member of University of Southampton Simon was born and educated in Southampton and then Oxford, graduating with a degree in modern languages (Italian and French). He is a qualified chartered accountant, having spent most of his career with the London office of Ernst & Young, where he specialised first in audit, then in transactions and finally risk management. He was a partner with Ernst & Young from 1994 to 2010. He joined the Trust Board on 1 January 2011 as a designate non-executive director and became non-executive director from 1 June 2011. He is chair of the audit and risk committee and a member of the strategy and finance committee. He also holds non-executive board positions in the social housing sector. Former partner in Ernst & Young LLP; Non-executive director and chair of audit committee, Radian Group; Non-executive director and chair of audit committee, Octavia Housing Dr Mike Sadler Non-executive director Mike joined UHS as a clinical non-executive director in September 2014, from a similar position at an NHS foundation trust providing mental health, learning disability and community services. He has chaired our quality committee since June 2016. He works as an advisor and consultant on health and social care services, recently advising on health reform in the Middle East, and in Ireland. He has been chair and technical adviser to the Diabetes Professional Care Conference since 2015, and also worked for the CQC as a specialist adviser in primary care. External clinical associate for PricewaterhouseCoopers; Member of the Advisory Board for xim (from 1 May) Mike graduated from Nottingham University, and was a GP principal in Hampshire before moving into public health medicine. Having achieved an MSc with distinction at the London School of Hygiene and Tropical Medicine, he joined Portsmouth and South East Hampshire Health Authority, holding the joint posts of deputy director of public health and medical adviser. He has since held a series of senior clinical leadership roles in national organisations in both the public and private sector, including as a chief operating officer at NHS Direct and Serco’s health division. His last full time role, up until July 2013 when he commenced his portfolio career, was as director of health and social care at West Sussex County Council. 27 ACCOUNTABILITY REPORT Board member Name Title Jenni Non-executive Douglas- director Todd Biography
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/annual-report-2017-181.pdf

Docetaxel

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) DOCETAXEL (75) Regimen NSCLC – Docetaxel (75) Indication Second line therapy of stage IIIB or IV NSCLC WHO Performance status 0, 1 Palliative intent Toxicity Drug Docetaxel Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen FBC, LFTs and U&Es prior to each cycle A chest x-ray should be performed before each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.2 (January 2014) Page 1 of 8 NSCLC – Docetaxel (75) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Prior to prescribing the following criteria must be met; Criteria Neutrophils Platelets Eligible Level 1.5x109/L or greater 100x109/L or greater Consider blood transfusion if the patient is symptomatic of anaemia or if the haemoglobin is less than 8g/dL If the neutrophils are less than 1.5 x109/, then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment at a dose of 60mg/m2. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If counts remain low continue with treatment at a dose of 60mg/m2. If the platelet level falls below 50 x 109/L stop treatment. Hepatic Impairment Drug Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN 1.5xULN or greater and/or 3.5xULN or greater and 2.5xULN or greater and 6xULN or greater Dose (% of original dose) Give 75% Not Recommended Renal Impairment Drug Docetaxel Creatinine Clearance (ml/min) N/A Dose (% of original dose) No dose adjustment needed Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose should then be reduced to 60mg/m2 or discontinued as appropriate. Version 1.2 (January 2014) Page 2 of 8 NSCLC – Docetaxel (75) Peripheral Neuropathy Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2 once the neuropathy has resolved to NCI-CTC grade 2 or below. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops consider stopping treatment. Lacrimation Excessive lacrimation is related to cumulative docetaxel doses and occurs after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 60mg/m2. Skin Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCI-CTC grade 4 cutaneous toxicity. Stomatitis A NCI-CTC grade 2 stomatitis should result in a delay in treatment until it has become NCI-CTC grade 1 or below. Treatment may then be re-started at the previous dose. For a NCI-CTC grade 3 stomatitis delay treatment until it has recovered to NCI-CTC grade 1 or below then reduce the dose to 60mg/m2. Treatment should be stopped in relation to a NCI-CTC grade 4 stomatitis. Regimen 21 day cycle for 4 cycles Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation) consider a starting dose of 60mg/m² with a view to increase to 75mg/m² if well tolerated. Drug Docetaxel Dose 75mg/m2 Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Dose Information Docetaxel will be banded as per the CSCCN agreed bands. Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses Version 1.2 (January 2014) Page 3 of 8 NSCLC – Docetaxel (75) Docetaxel doses of more than 200mg should be diluted in 500ml sodium chloride 0.9% (maximum concentration 0.74mg/ml) Administration Information Docetaxel hypersensitivity reactions tend to occur with the first or second infusion. For minor symptoms such as flushing or localised rashes the infusion should not be interrupted. For severe reactions including profound hypotension, bronchospasm and generalised erythema discontinue the infusion immediately. Extravasation Docetaxel - exfoliant Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy; - metoclopramide 10mg oral or intravenous As take home medication; - metoclopramide 10mg three times a day oral when required To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice daily oral for three days starting 24 hours before docetaxel administration. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg intravenous Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Prophylactic antibiotics can be considered if required Growth factors may be considered according to local policy. Coding Procurement – X71.1 Delivery – X72.3 References 1.National Institute of Clinical Excellence (2005). CG24. The Diagnosis and Treatment of Lung Cancer. Methods, Evidence and Guidance. DOH: London. Version 1.2 (January 2014) Page 4 of 8 NSCLC – Docetaxel (75) 2.Fossella FV, DeVore R, Kerr RN et al. Randomised phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small cell lung cancer previously treated with platinum containing chemotherapy regimens. The TAX 320 study non-small cell lung cancer study group. J Clin Oncol; 2000: 18 (12): 2354-2362. 3.Shepherd FA, Dancey J, Ramlau R et al. Prospective randomised trial of docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum based chermotherapy. J Clin Oncol 2000; 18 (10): 2095-2103. Version 1.2 (January 2014) Page 5 of 8 NSCLC – Docetaxel (75) REGIMEN SUMMARY Docetaxel (75) Cycle 1, 2, 3 Day Minus One 1. Dexamethasone 8mg twice a day oral* Day One 2. Dexamethsone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion* 6. Metoclopramide 10mg three times a day when required oral Cycle 4 Day Minus One 7. Dexamethasone 8mg twice a day oral* Day One 8. Dexamethsone 8mg twice a day oral (from TTO)* 9. Metoclopramide 10mg oral or intravenous 10. Docetaxel 75mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 11. Metoclopramide 10mg three times a day when required oral * In Aria Planner the dexamethasone 8mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The patient should have been given the supply for cycle one in the pre-assessment or consent clinic. The administration instructions reflect this. Version 1.2 (January 2014) Page 6 of 8 NSCLC – Docetaxel (75) Document Control Version Date Amendment Written By 1.2 Jan 2014 Header and footer changed Dr Deborah Wright Name changed to Docetaxel Pharmacist (75) Toxicity removed and tabulated written in full Haematological criteria tabulated Renal and hepatic recommendations updated and tabulated Other toxicities added as per prostate regimens Regimen tabulated and recommendations on starting dose added Dosing information extended Hypersensitivity recommendations added Administartion routes written in full, bolus and stat removed Metoclopramide dose changed Name added under summary Cycle four added to exclude dexamethasone TTO. Document control tabulated Hospitals and disclaimer added 1.1 23rd Sept Font changed to Arial Dr Deborah Wright 2010 Header altered to include Pharmacist “Strength through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not information) changed Coding added Summary page added Document control added Approved By Donna Kimber Pharmacy Technician Donna Kimber Pharmacy Technician Version 1.2 (January 2014) Page 7 of 8 NSCLC – Docetaxel (75) This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (January 2014) Page 8 of 8 NSCLC – Docetaxel (75)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Docetaxelver12.pdf

Docetaxel (75)-Prednisolone ver1.2

Description: Chemotherapy Protocol PROSTATE DOCETAXEL(75)-PREDNISOLONE Regimen Prostate-Docetaxel (75)-Prednisolone Indication Advanced castrate resistant prostate cancer Performance status 0, 1, 2 Toxicity Drug Docetaxel Prednisolone Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, osteoporosis The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFTs, PSA and U&Es prior to each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Version 1.2 (May 2015) Page 1 of 7 Prostate-Docetaxel(75)-Prednisolone Haematological Consider a blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to cycle one the following criteria should be met; Criteria Neutrophils Platelets Eligible Level 1x109/L or greater 50x109/L or greater Dose modifications based on haematological parameters apply to docetaxel only. Neutrophils (x109/L) 1 or greater less than 1 on the day of treatment or less than 1 with fever/infection at any time or less than 0.5 for more than 7 days Platelets (x109/L) 50 or greater less than 50 Dose Modifications (docetaxel) 100% 1st Occurrence Delay until recovery to 1x109/L or greater and then give 60mg/m2 2nd Occurrence Delay until recovery to 1x109/L or greater then give 45mg/m2 Dose Modifications (docetaxel) 100% 1st Occurrence Delay until recovery to 50x109/L or greater then give 60mg/m2 2nd Occurrence Delay until recovery to 50x109/L or greater then give 45mg/m2 Hepatic Impairment Consider weekly scheduling if there is a mild or moderate hepatic impairment Drug Bilirubin (μmol/L) AST/ALT (units/L) Alk Phos Dose (units/L) (% of original dose) N/A greater than 1.5xULN and greater than 2.5xULN Docetaxel greater than ULN and/ or greater than 3.5xULN and greater than 6xULN Give 75% Not Recommended Renal Impairment Drug Docetaxel Creatinine Clearance (ml/min) N/A Dose (% of original dose) No dose adjustment needed Version 1.2 (May 2015) Page 2 of 7 Prostate-Docetaxel(75)-Prednisolone Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose should then be reduced to 60mg/m2 or discontinued as appropriate. The following recommendations apply to docetaxel only. The prednisolone should be continued if the docetaxel is delayed. It should be stopped if the docetaxel is stopped but may require a reducing schedule. Peripheral Neuropathy Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2 once the neuropathy has resolved to NCI-CTC grade 2 or below. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops consider stopping treatment. Lacrimation Excessive lacrimation is related to cumulative docetaxel doses and occurs after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 60mg/m2. Skin Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCI-CTC grade 4 cutaneous toxicity. Stomatitis A NCI-CTC grade 2 stomatitis should result in a delay in treatment until it has become NCICTC grade 1 or below. Treatment may then be re-started at the previous dose. For a NCICTC grade 3 stomatitis delay treatment until it has recovered to NCI-CTC grade 1 or below then reduce the dose to 60mg/m2. Treatment should be stopped in relation to a NCI-CTC grade 4 stomatitis. Version 1.2 (May 2015) Page 3 of 7 Prostate-Docetaxel(75)-Prednisolone Regimen Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation) consider a starting dose of 60mg/m² with a view to increase to 75mg/m² if well tolerated. 21 day cycle for up to 10 cycles Drug Docetaxel Prednisolone Dose 75mg/m2 5mg twice a day Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 1-21 incl. Oral Dose Information Docetaxel will be banded as per the CSCCN agreed bands. Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses Docetaxel doses of more than 200mg should be diluted in 500ml sodium chloride 0.9% (maximum concentration 0.74mg/ml) Prednisolone is available as 5mg (uncoated) and 2.5mg and 5mg (enteric coated) tablets. Administration Information Docetaxel hypersensitivity reactions tend to occur with the first or second infusion. For minor symptoms such as flushing or localised rashes the infusion should not be interrupted. For severe reactions including profound hypotension, bronchospasm and generalised erythema discontinue the infusion immediately. Prednisolone should be taken with or after food. Extravasation Docetaxel - exfoliant Additional Therapy Premedication - dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel Antiemetics 15-30 minutes prior to chemotherapy - metoclopramide 10mg oral or intravenous Version 1.2 (May 2015) Page 4 of 7 Prostate-Docetaxel(75)-Prednisolone As take home medication - metoclopramide 10mg oral three times a day for 3 days then as required Coding (OPCS) Procurement – X71.1 Delivery – X72.3 References 1.Tannock IF, deWit R, Berry WR et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351 (15): 1502-1512. 2.NICE Guidance TA101. Docetaxel for the treatment of hormone refractory metastatic prostate cancer; June 2006. 3.STAMPEDE trial protocol. Version 7.1. 21st June 201 Version 1.2 (May 2015) Page 5 of 7 Prostate-Docetaxel(75)-Prednisolone REGIMEN SUMMARY Docetaxel (75)-Prednisolone Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9 Day minus 1 1. Dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel (from TTO)* Day 1 2. Dexamethasone from TTO (see above)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m2 in 250ml sodium chloride 0.9% intravenous infusion over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication prior to treatment. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone premedication administer dexamethasone 20mg intravenous stat 15-30 minutes prior to chemotherapy Take Home Medicines 5. Prednisolone 5mg twice a day oral for 21 days Administration Instructions Take with or after food. The dose of this medicine may need to be reduced gradually before stopping treatment. 6. Dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel 7. Metoclopramide 10mg oral three times a day for 3 days then 10mg three times a day when required for nausea. Cycle 10 Day minus 1 8. Dexamethasone 8mg oral at 12 hours, 3 hours and 1 hour prior to docetaxel (from TTO)* Day 1 9. Dexamethasone from TTO (see above)* 10. Metoclopramide 10mg oral or intravenous 11. Docetaxel 75mg/m2 in 250ml sodium chloride 0.9% intravenous infusion over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication prior to treatment. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone premedication administer dexamethasone 20mg intravenous stat 15-30 minutes prior to chemotherapy Take Home Medicines 12. Prednisolone 5mg twice a day oral for 21 days Administration Instructions Take with or after food. The dose of this medicine may need to be reduced gradually before stopping treatment. 13. Metoclopramide 10mg oral three times a day for 3 days then 10mg three times a day when required for nausea. * In Aria Planner the dexamethasone TTO will appear on day 1 of treatment. This is the supply for the next cycle. Version 1.2 (May 2015) Page 6 of 7 Prostate-Docetaxel(75)-Prednisolone DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed Metoclopramide dose changed to 10mg Bolus removed from intravenous bolus throughout text Hepatic dose modification table 1.2 May 2015 updated Docetaxel admin instructions added Donna Kimber Pharmacy Technician Dexamethasone TTO updated Prednisolone admin instructions updated OPCS codes updated Disclaimer added Dexamethasone changed to dexamethasone 8mg oral twice 1.1 May 2013 a day the day before, the day of and the day after docetaxel in Dr Debbie Wright Pharmacist additional therapy section and also treatment summary. 1 Jan 2013 None Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Rebecca Wills Pharmacist Dr Mathew Wheater Consultant Medical Oncologist Dr Joanna Gale Consultant Medical Oncologist Dr Mathew Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (May 2015) Page 7 of 7 Prostate-Docetaxel(75)-Prednisolone
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Prostatecancer/Docetaxel-75-Prednisolone-ver1.2.pdf

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