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Systemic Anti-Cancer Therapy Regimen Library

Home > GYN CX Advanced - cISplatin, PACLItaxel, beVACizumab and pembrolizumab

GYN CX Advanced - cISplatin, PACLItaxel, beVACizumab and pembrolizumab

Treatment Overview

Usually up to 6 cycles of cISplatin, PACLItaxel, beVACizumab and pembrolizumab.

BeVACizumab and pembrolizumab may continue until disease progression or unacceptable toxicity (up to 2 years for pembrolizumab).


This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycles 1 to 6 - 21 days - cISplatin, PACLItaxel, beVACizumab and pembrolizumab

Cycle length:
21

Cycle 7 (and all further cycles) - 21 days - beVACizumab and pembrolizumab continuation

Cycle length:
21

Cycle details

Cycles 1 to 6 - 21 days - cISplatin, PACLItaxel, beVACizumab and pembrolizumab

Medication Dose Route Days Max Duration
dexamethasone * 20 mg oral administration 0
olanzapine * 5 mg oral administration 1 to 4
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
dexamethasone * 12 mg oral administration 1
dexamethasone * 8 mg oral administration 2, 3, 4
ondansetron 8 mg oral administration 1
loratadine * 10 mg oral administration 1
famotidine * 20 mg oral administration 1
pembrolizumab 200 mg flat dosing intravenous 1 30 minutes
beVACizumab 15 mg/kg intravenous 1 90 minutes
PACLItaxel * 175 mg/m² intravenous 1 3 hours
magnesium sulfate heptahydrate 10 mmol intravenous 1 60 minutes
cISplatin * 50 mg/m² intravenous 1 60 minutes
sodium chloride 0.9 % intravenous 1 60 minutes
ondansetron 8 mg oral administration 1
cyclIZINE 50 mg Three times daily oral administration 1

Cycle 7 (and all further cycles) - 21 days - beVACizumab and pembrolizumab continuation

Medication Dose Route Days Max Duration
pembrolizumab 200 mg flat dosing intravenous 1 30 minutes
beVACizumab 15 mg/kg intravenous 1 90 minutes

Full details

Cycles 1 to 6 - 21 days - cISplatin, PACLItaxel, beVACizumab and pembrolizumab

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 20 mg oral administration
Instructions:

Take the night prior to PACLItaxel infusion with food.

If the initial infusion(s) of PACLItaxel are well tolerated, clinicians may decide at their discretion, to omit this dose.

Day: 1

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

  • This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
  • Some centres may choose to omit pre-chemotherapy dose or advise patient to take the night before chemotherapy if patient has to drive to appointment.
aprepitant 125 mg oral administration
Instructions:
ONE hour prior to chemotherapy.
dexamethasone * 12 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
loratadine * 10 mg oral administration
Instructions:

ONE hour prior to PACLitaxel infusion.
famotidine * 20 mg oral administration
Instructions:

ONE hour prior to PACLitaxel infusion.

Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
pembrolizumab 200 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 5 micron in-line or add-on filter.
beVACizumab 15 mg/kg intravenous 90 minutes
Instructions:
  • Blood pressure and urinalysis should be checked before each administration. If urine dipstick protein is less than or equal to 3+, proceed with infusion.
  • If the initial dose of beVACizumab is well tolerated, the second dose may be administered over 60 minutes, and the third and subsequent doses may be administered over 30 minutes.
PACLItaxel * 175 mg/m² intravenous 3 hours
Instructions:
  • Prepare solution in PVC-free bag and administer via polyethylene lined administration set with an in-line filter of 0.22 microns or less in size.
  • Please carry out graded challenge as per institutional policy.
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin * 50 mg/m² intravenous 60 minutes
Instructions:
  • In 500 - 1000 mL of sodium chloride 0.9%, depending on stability.
  • Ensure patient has passed urine as per institutional policy.
  • Hypersensitivity risk increases with number of cycles of cISplatin.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:

After cISplatin infusion. If cISplatin is infused in 1000 mL, centres may choose to omit this bag of fluid.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
cyclIZINE 50 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

  • Warning: may cause drowsiness.
  • Consider starting dose at 25 mg and increasing as tolerated/required.
  • The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
  • Note that domperidone is not recommended in combination with olanzapine and ondansetron due to potential risk of QT prolongation.

Day: 2

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

Day: 3

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
aprepitant 80 mg oral administration
Instructions:
ONCE daily in the morning.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

Day: 4

Medication Dose Route Max duration Details
olanzapine * 5 mg oral administration
Instructions:

ONCE daily.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

Cycle 7 (and all further cycles) - 21 days - beVACizumab and pembrolizumab continuation

Day: 1

Medication Dose Route Max duration Details
pembrolizumab 200 mg flat dosing intravenous 30 minutes
Instructions:
Administer via a sterile, non-pyrogenic, low protein binding 0.2 to 5 micron in-line or add-on filter.
beVACizumab 15 mg/kg intravenous 90 minutes
Instructions:
  • Blood pressure and urinalysis should be checked before each administration. If urine dipstick protein is less than or equal to 3+, proceed with infusion.
  • If the initial dose of beVACizumab is well tolerated, the second dose may be administered over 60 minutes, and the third and subsequent doses may be administered over 30 minutes.

Supportive Care Factors

Factor Value
Emetogenicity: Variable
Hydration: Variable
Hypersensitivity / Infusion related reaction risk: Variable

Emetogenicity:

  • HIGH cycles 1 to 6.
  • MINIMAL cycle 7 onwards.

Hydration: Routine hydration recommended in cycles 1 to 6.


Hypersensitivity/Infusion related reaction risk:

  • HIGH—Routine premedication recommended cycles 1 to 6.
  • LOW—Routine premedication not recommended cycle 7 onwards.

References

Moore DH, Blessing JA, McQuellon RP, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004;22:3113-3119., PMID: 15284262

Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, et al. European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol. 1994;12:2654-2666., PMID: 7989941

Monk BJ, Sill MW, McMeekin DS, et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009;27:4649-4655., PMID: 19720909

Kitagawa R, Katsumata N, Shibata T, Kamura T, Kasamatsu T, Nakanishi T, Nishimura S, Ushijima K, Takano M, Satoh T, Yoshikawa H. Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Cisplatin in Metastatic or Recurrent Cervical Cancer: The Open-Label Randomized Phase III Trial JCOG0505. J Clin Oncol. 2015 Jul 1;33(19):2129-35. doi: 10.1200/JCO.2014.58.4391. Epub 2015 Mar 2. , PMID: 25732161

Novartis New Zealand Ltd. Paclitaxel Ebewe New Zealand Data Sheet 16 April 2020. https://www.medsafe.govt.nz/profs/Datasheet/p/PaclitaxelEbeweinj.pdf (Accessed 26 November 2020).

Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yañez E, Gümüş M, Olivera Hurtado de Mendoza M, Samouëlian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18., PMID: 34534429

Tewari, K. S., M. W. Sill, H. J. Long, 3rd, et al. 2014. "Improved survival with bevacizumab in advanced cervical cancer." N Engl J Med 370(8):734-743. , PMID: 24552320

Tewari, K. S., M. W. Sill, R. T. Penson, et al. 2017. "Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)." Lancet., PMID: 28756902

Boulanger J, Boursiquot JN, Cournoyer G, et al. Management of hypersensitivity to platinum- and taxane-based chemotherapy: cepo review and clinical recommendations. Curr Oncol. 2014;21(4):e630-e641., PMID: 25089112

Castells, M.C., Matulonis, U.A., and Horton, TM. Infusion reactions to systemic chemotherapy. Savarese DMF and Feldweg AM, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/infusion-reactions-to-systemic-chemotherapy (Accessed 26 March 2021).

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142. , PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.