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Systemic Anti-Cancer Therapy Regimen Library

GU Penile Advanced - TPF [DOCEtaxel, cISplatin, fluorouracil]

Treatment Overview

Give 3 or 4 cycles.


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 4 - 21 days

Cycle length:
21

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 10 mg prior to DOCEtaxel infusion.

Cycle details

Cycles 1 to 4 - 21 days

Medication Dose Route Days Max Duration
dexamethasone * 8 mg Twice daily oral administration 0, 1, 2
dexamethasone * 8 mg oral administration 3, 4
olanzapine * 5 mg oral administration 1 to 4
aprepitant 125 mg oral administration 1
aprepitant 80 mg oral administration 2, 3
ondansetron 8 mg oral administration 1
DOCEtaxel * 75 mg/m² intravenous 1 60 minutes
magnesium sulfate heptahydrate 10 mmol intravenous 1 60 minutes
cISplatin * 75 mg/m² intravenous 1 60 minutes
sodium chloride 0.9 % intravenous 1 60 minutes
fluorouracil * 3000 mg/m² intravenous 1 96 hours Min: 96 hours
ondansetron 8 mg oral administration 1
pegFILGRASTIM 6 mg subcutaneous injection 5
cyclIZINE 50 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Some centres may wish to replace the three oral doses of dexamethasone 8 mg premedication with a single intravenous dose of dexamethasone 10 mg prior to DOCEtaxel infusion.

Full details

Cycles 1 to 4 - 21 days

Day: 0

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food.

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food.

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.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

DOCEtaxel * 75 mg/m² intravenous 60 minutes
Instructions:

Prepare solution in PVC-free bag and administer via polyethylene lined administration set.

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 * 75 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.

fluorouracil * 3000 mg/m² intravenous 96 hours Min: 96 hours
Instructions:

Continuous infusion via pump over 96 hours (equivalent to 750 mg/m2/day).

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.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food.

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.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

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

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.

Day: 4

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

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

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.

Day: 5

Medication Dose Route Max duration Details
pegFILGRASTIM 6 mg subcutaneous injection

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: High
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended

References

Necchi A, Nicolai N, Colecchia M, Catanzaro M, Torelli T, Piva L, Salvioni R. Proof of activity of anti-epidermal growth factor receptor-targeted therapy for relapsed squamous cell carcinoma of the penis. J Clin Oncol. 2011 Aug 1;29(22):e650-2. doi: 10.1200/JCO.2011.34.8367. Epub 2011 May 31., PMID: 21632506

Nicholson S, Hall E, Harland SJ, Chester JD, Pickering L, Barber J, Elliott T, Thomson A, Burnett S, Cruickshank C, Carrington B, Waters R, Bahl A. Phase II trial of docetaxel, cisplatin and 5FU chemotherapy in locally advanced and metastatic penis cancer (CRUK/09/001). Br J Cancer. 2013 Nov 12;109(10):2554-9. doi: 10.1038/bjc.2013.620. Epub 2013 Oct 29., PMID: 24169355

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).

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

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* 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.