Thames Valley SACT Regimens

1 Thames Valley Gynae SACT Regimens 1 Thames Valley SACT Regimens Gynaecological Cancer Thames Valley Gynae SACT Regimens Page 2 of 86 Notes from the editor Theseregimens are available on the Network website Any correspondence about the Regimens should be addressed to: Sally Coutts, Cancer Pharmacist, Thames Valley email: Tel: 01865 857166 Acknowledgements These Regimens have been compiled by the Network Pharmacy Group in collaboration with the Gynae CAG with key contribution from Dr Bernadette Lavery, Consultant Oncologist, OUH Dr Clive Charlton, Consultant Oncologist, RBFT Dr Marcia Hall, Consultant Oncologist, HWP Prof Sean Kehoe, Consultant Gynaecologist, OUH Karen Carter, Oncology Pharmacist, RBFT Thames Valley Cancer Network.

2 All rights reserved. Not to be reproduced in whole or in part without the permission of the copyright owner. Thames Valley Gynae SACT Regimens Page 3 of 86 Thames Valley SACT Regimens Gynaecological Cancer Theregimens listed below were approved for use within the Thames Valley Cancer Network by the Gynae CAG. Date published: January 2019 Date of review: January 2021 SACT Regimens Name of regimen Indication Page List of modifications to this version 5 Bevacizumab 15mg/kg Cervical, 6 BIP inpatient Recurrent cervical carcinoma 8 Cisplatin 40 weekly with RT Advanced cervical carcinoma 11 Cisplatin 70 pre radiotherapy Advanced cervical carcinoma 13 Cisplatin 50 Recurrent cervical carcinoma 15 Topotecan Cisplatin Recurrent cervical carcinoma 17 BEP 3 day metastatic Non-seminomatous germ cell 19 BEP 5 day metastatic Non-seminomatous germ cell 22 BEP 3 day adjuvant Non-seminomatous germ cell 25 EMA / CO Gestational trophoblastic disease 28 Carboplatin AUC7 Dysgerminoma and seminoma 29 Methotrexate 50 Germ cell 30

3 Methotrexate weekly Germ cell 31 Bevacizumab Ovarian, fallopian, peritoneal 32 Carboplatin desensitisation 34 Niraparib Ovarian, fallopian tube, peritoneal 36 Paclitaxel carboplatin 21 day Ovarian + endometrial + cervical 39 Paclitaxel cisplatin Ovarian 41 Carboplatin 21 day Ovarian 43 Carboplatin 28 day Ovarian 45 Cisplatin / oral etoposide Relapsed ovarian 47 Cisplatin weekly Relapsed ovarian 50 Cisplatin 21 day Recurrent ovarian 52 Etoposide IV Recurrent ovarian 54 Etoposide oral Recurrent ovarian 55 Thames Valley Gynae SACT Regimens Page 4 of 86 Name of regimen cont.

4 Indication Page Gemcitabine Cisplatin Recurrent ovarian 56 Liposomal doxorubicin (Caelyx) Recurrent / resistant ovarian 59 Olaparib capsules Ovarian, Fallopian 61 Paclitaxel 3 weekly Recurrent / relapsed ovarian 63 Paclitaxel weekly Recurrent ovarian 65 Gemcitabine Carboplatin Ovarian cancer 67 Paclitaxel 7 day and carboplatin Advanced ovarian cancer 69 Paclitaxel 7 day and carboplatin 7 day Advanced ovarian cancer 71 Liposomal doxorubicin and carboplatin Advanced ovarian cancer 73 Doxorubicin Endometrial cancer 75 Doxorubicin + cisplatin Endometrial cancer 76 Doxorubicin + ifosfamide Adjuvant uterine sarcoma 78 Doxorubicin (30)

5 + ifosfamide (3g) Metastatic uterine sarcoma 81 Ifosfamide nomogram 84 Hydration Regimens 86 Carboplatin may be substituted with cisplatin in those patients hypersensitive to carboplatin, unless soecified in CDF or NICE criteria. Cisplatin may be substituted with carboplatin in those patients hypersensitive to cisplatin, unless soecified in CDF or NICE criteria. Thames Valley Gynae SACT Regimens Page 5 of 86 List of amendments in this version Regimen type: Gynae Tumours Date due for review: January 2021 Previous Version number: This version number.

6 Table 1 Amendments Page Action Type Amendment Made/ asked by Diluents amended as per national dose specifications Table 2 New Regimens to be approved and checked by CAG included in this version Name of regimen Indication Reason / Proposer Gemcitabine Cisplatin Ovarian Dr Nicum Carboplatin desensitisation desensitisation Dr Nicum Bevacizumab CDF Bevacizumab CDF Olaparib NICE Niraparib CDF For anti-emetic guidelines: For dose banded chemotherapy standardized product specifications: Thames Valley Gynae SACT Regimens Page 6 of 86 BEVACIZUMAB (15mg/kg) Indication: The first line palliative chemotherapy treatment of primary stage IVB recurrent or persistent disease not amenable to curative treatment with surgery and/or cancer in combination with Paclitaxel and either Cisplatin or Carboplatin chemotherapy, no previous treatment with bevacizumab or other anti-VEGF therapy.

7 PS 0 or 1 DRUG REGIMEN Day 1 BEVACIZUMAB 15mg/kg IV in 100ml sodium chloride infusion over 90* minutes. * The initial dose should be administered over 90 minutes, if tolerated well the second infusion may be administered over 60 minutes. If the 60 minute infusion is well tolerated all subsequent infusions may be administered over 30 minutes. Cycle frequency: Repeat every 21 days until disease progression DOSE MODIFICATIONS Renal impairment no studies have been conducted to investigate bevacizumab in renal impairment since the kidneys are not a major organ for bevacizumab metabolism or excretion.

8 Clinical decision Hepatic impairment no studies have been conducted to investigate bevacizumab in hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion. Clinical decision INVESTIGATIONS Routine Blood tests 1. Blood results required before SACT administration Give Discuss Hb x g/dL 10 <10 Plt x 109/L 100 <100 Neutrophils x 109/L < 2. Non-urgent Blood tests Tests relating to disease response/progression. CONCURRENT MEDICATIONS ANTI-EMETIC POLICY Minimal emetic risk Bevacizumab cervical Gynae CAG Chair Authorisation: Date: Page 1 of 2 Published: January 2019 Review: January 2021 Version Thames Valley Gynae SACT Regimens Page 7 of 86 ADVERSE EFFECTS / REGIMEN SPECIFIC COMPLICATIONS Gastrointestinal perforation Haemorrhage Arterial thromboembolism REFERENCES 1.

9 Bevacizumab January 2005 2. CDF Bevacizumab cervical Gynae CAG Chair Authorisation: Date: Page 2 of 2 Published: January 2019 Review: January 2021 Version Thames Valley Gynae SACT Regimens Page 8 of 86 BIP inpatient (Cervix) Indication: Recurrent cervical carcinoma DRUG REGIMEN Day 1 BLEOMYCIN 30,000units in 1000ml sodium chloride infusion over 24 hours Pre-hydration CISPLATIN 50mg/m2 in 1000ml sodium chloride infusion over 4 hours Post hydration Day 2 MESNA 1g/m2 IV bolus IFOSFAMIDE and MESNA in 1L sodium chloride infusion over 8 hours IFOSFAMIDE and MESNA in 1L sodium chloride infusion over 8 hours IFOSFAMIDE and MESNA in 1L sodium chloride infusion over 8 hours MESNA 3g/m2 in 1L sodium chloride infusion over 12 hours Cycle Frequency.

10 Every 21 days for 6 cycles NB. Some evidence that IP is as good as BIP therefore bleomycin may be omitted at consultant s discretion [1]. Cisplatin may be given on day 3 (instead of day 1) if the patient doesn t have a line inserted. DOSE MODIFICATIONS This regimen is ideally only given with normal renal function. Previous neutropenic sepsis, discuss with SpR or Consultant Cisplatin: GFR >60ml/min give 100% dose GFR 45-60ml/min give 75% dose GFR <45ml/min consider carboplatin [3] If patient complains of tinnitus, tingling of fingers and/or toes discuss with SpR or Consultant before administration.