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Systemic Anti-Cancer Therapy Regimen Library

SAR STS Metastatic - DOCEtaxel and gemcitabine 900

Treatment Overview

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

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 20 mg prior to DOCEtaxel infusion.

Cycle details

Cycles 1 to 6 - 21 days

Medication Dose Route Days Max Duration
ondansetron * 8 mg oral administration 1
gemcitabine * 900 mg/m² intravenous 1, 8 90 minutes
dexamethasone * 8 mg Twice daily oral administration 7, 8, 9
DOCEtaxel * 75 mg/m² intravenous 8 60 minutes
pegFILGRASTIM 6 mg subcutaneous injection 9
domperidone 10 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 20 mg prior to DOCEtaxel infusion.

Full details

Cycles 1 to 6 - 21 days

Day: 1

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

ONE hour prior to chemotherapy.

Alternative is dexamethasone 4 mg.

gemcitabine * 900 mg/m² intravenous 90 minutes
Instructions:

Administer at a rate of 10 mg/m2/minute.

domperidone 10 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.

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: 7

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

Take with food.

Day: 8

Medication Dose Route Max duration Details
gemcitabine * 900 mg/m² intravenous 90 minutes
Instructions:

Administer at a rate of 10 mg/m2/minute.

dexamethasone * 8 mg Twice daily oral administration
Instructions:

Take with food.

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.

Day: 9

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

Take with food.

pegFILGRASTIM 6 mg subcutaneous injection

Supportive Care Factors

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

References

Hensley, M. L., J. A. Blessing, R. Mannel, et al. 2008. "Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial." Gynecol Oncol 109(3):329-334., PMID: 18534250

Hensley, M. L., A. Miller, D. M. O'Malley, et al. 2015. "Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study." J Clin Oncol 33(10):1180-1185., PMID: 25713428

Hensley, M. L., J. A. Blessing, K. Degeest, et al. 2008. "Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II study." Gynecol Oncol 109(3):323-328., PMID: 18394689

Pautier, P., A. Floquet, L. Gladieff, et al. 2013. "A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). A study of the French Sarcoma Group." Ann Oncol 24(4):1099-1104., PMID: 23139262

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

Pfizer New Zealand Limited. DBL Docetaxel New Zealand Data Sheet 07 August 2020. https://www.medsafe.govt.nz/profs/Datasheet/d/dbldocetaxelinj.pdf (Accessed 26 November 2020).

* 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.