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Systemic Anti-Cancer Therapy Regimen Library

GU GCT Non-seminoma Adjuvant - BEP [bleomycin, etoposide and cISplatin]

Treatment Overview

Give 1 or 2 cycles.


For patients over 40 years, consider an alternative regimen that does not contain bleomycin.


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 2 - 21 days

Cycle length:
21

pegFILGRASTIM: Use or omit as per institutional practice.

Cycle details

Cycles 1 to 2 - 21 days

Medication Dose Route Days Max Duration
olanzapine * 5 mg oral administration 1 to 8
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 to 8
ondansetron 8 mg oral administration 1 to 5
hydrocortisone 100 mg intravenous 15 2 minutes
bleomycin * 30000 international unit flat dosing intravenous 1, 8, 15 10 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 1 to 5 60 minutes
cISplatin 20 mg/m² Once daily intravenous 1 to 5 60 minutes
sodium chloride 0.9 % intravenous 1 to 5 60 minutes
etoposide (as phosphate) 100 mg/m² Once daily intravenous 1 to 5 60 minutes
ondansetron 8 mg oral administration 1 to 5
cycliZINE 50 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1
pegFILGRASTIM 6 mg subcutaneous injection 6

pegFILGRASTIM: Use or omit as per institutional practice.

Full details

Cycles 1 to 2 - 21 days

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.

bleomycin * 30000 international unit flat dosing intravenous 10 minutes
Instructions:
High risk of febrile infusion reaction.
magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin 20 mg/m² Once daily 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.

etoposide (as phosphate) 100 mg/m² Once daily intravenous 60 minutes
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.
docusate sodium + sennoside B 2 Tablet(s) oral administration
Instructions:

At night when required for constipation.

Each tablet contains docusate sodium 50 mg + sennoside B 8 mg.

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin 20 mg/m² Once daily 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.

etoposide (as phosphate) 100 mg/m² Once daily intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin 20 mg/m² Once daily 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.

etoposide (as phosphate) 100 mg/m² Once daily intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin 20 mg/m² Once daily 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.

etoposide (as phosphate) 100 mg/m² Once daily intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 5

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

magnesium sulfate heptahydrate 10 mmol intravenous 60 minutes
Instructions:
In 1000 mL of sodium chloride 0.9%, prior to cISplatin infusion.
cISplatin 20 mg/m² Once daily 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.

etoposide (as phosphate) 100 mg/m² Once daily intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 6

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.

pegFILGRASTIM 6 mg subcutaneous injection
Instructions:

Use or omit as per institutional practice.

Day: 7

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.

Day: 8

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:

ONE hour prior to bleomycin with food.

bleomycin * 30000 international unit flat dosing intravenous 10 minutes
Instructions:
High risk of febrile infusion reaction.

Day: 15

Medication Dose Route Max duration Details
hydrocortisone 100 mg intravenous 2 minutes
Instructions:

30 minutes prior to bleomycin.

Use for subsequent doses ONLY if previous febrile reaction or as per institutional practice.

bleomycin * 30000 international unit flat dosing intravenous 10 minutes
Instructions:
High risk of febrile infusion reaction.

Supportive Care Factors

Factor Value
Constipation risk: laxatives are usually prescribed
Emetogenicity: Variable
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

Emetogenicity: HIGH days 1 to 5; MINIMAL days 8 and 15.

References

Pont J, Holtl W, Kosak D et al. 1990 Risk-adapted treatment choice in stage I nonseminomatous testicular germ cell cancer by regarding vascular invasion in the primary tumor: a prospective trial. J Clin Oncol 8:16-20, PMID: 1688613

Pont, J., W. Albrecht, G. Postner, et al. 1996. "Adjuvant chemotherapy for high-risk clinical stage I nonseminomatous testicular germ cell cancer: long-term results of a prospective trial." J Clin Oncol 14(2):441-448., PMID: 8636755

Cullen, M., R. Huddart, J. Joffe, et al. 2020. "The 111 Study: A Single-arm, Phase 3 Trial Evaluating One Cycle of Bleomycin, Etoposide, and Cisplatin as Adjuvant Chemotherapy in High-risk, Stage 1 Nonseminomatous or Combined Germ Cell Tumours of the Testis." Eur Urol 77(3):344-351., PMID: 31901440

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://wwwuptodate.com (Accessed 26 March 2021).

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

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

* 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.