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Systemic Anti-Cancer Therapy Regimen Library

SAR Ewing sarcoma Relapsed - CYCLOPHOSPHamide and topotecan

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

Cycle details

Cycles 1 to 6 - 21 days

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1 to 7
ondansetron 8 mg oral administration 1 to 5
CYCLOPHOSPHamide * 250 mg/m² Once daily intravenous 1 to 5 30 minutes
topotecan 0.75 mg/m² Once daily intravenous 1 to 5 30 minutes
ondansetron 8 mg oral administration 1 to 5
pegFILGRASTIM 6 mg subcutaneous injection 6
domperidone 10 mg Three times daily oral administration 1
docusate sodium + sennoside B 2 Tablet(s) oral administration 1

Full details

Cycles 1 to 6 - 21 days

Day: 1

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

ONE hour prior to chemotherapy with food.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

CYCLOPHOSPHamide * 250 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer before topotecan.

topotecan 0.75 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer after CYCLOPHOSPHamide.

ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

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.

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
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.

CYCLOPHOSPHamide * 250 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer before topotecan.

topotecan 0.75 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer after CYCLOPHOSPHamide.

ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

CYCLOPHOSPHamide * 250 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer before topotecan.

topotecan 0.75 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer after CYCLOPHOSPHamide.

ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

CYCLOPHOSPHamide * 250 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer before topotecan.

topotecan 0.75 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer after CYCLOPHOSPHamide.

ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 5

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.

ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.

CYCLOPHOSPHamide * 250 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer before topotecan.

topotecan 0.75 mg/m² Once daily intravenous 30 minutes
Instructions:

Administer after CYCLOPHOSPHamide.

ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 6

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.

pegFILGRASTIM 6 mg subcutaneous injection

Day: 7

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.

Supportive Care Factors

Factor Value
Constipation risk: laxatives are usually prescribed
Emetogenicity: Medium
Growth factor support: Recommended for primary prophylaxis

References

Saylors RL, Stine KC, Sullivan J, et al. Cyclophosphamide plus topotecan in children with recurrent or refractory solid tumors: a Pediatric Oncology Groupphase II study. J Clin Oncol 2001;19:3463-3469., PMID: 11481351

Hunold A, Weddeling N, Paulussen M, et al. Topotecan and cyclophosphamide in patients with refractory or relapsed Ewing tumors. Pediatric Blood & Cancer 2006; 47: 795–800., PMID: 16411206

McCabe, M., L. Kirkton, M. Khan et al, 2022. "Phase III assessment of topotecan and cyclophosphamide and high-dose ifosfamide in rEECur: An international randomized controlled trial of chemotherapy for the treatment of recurrent and primary refractory Ewing sarcoma (RR-ES)." J Clin Oncol 40(17) suppl.

Kushner, B. H., K. Kramer, P. A. Meyers, et al. 2000. "Pilot study of topotecan and high-dose cyclophosphamide for resistant pediatric solid tumors." Med Pediatr Oncol 35(5):468-474., PMID: 11070479

Farhat, R., R. Raad, N. J. Khoury, et al. 2013. "Cyclophosphamide and topotecan as first-line salvage therapy in patients with relapsed ewing sarcoma at a single institution." J Pediatr Hematol Oncol 35(5):356-360. , PMID: 23042020

Blanchette, P., D. Hogg, P. Ferguson, et al. 2012. "Topotecan and cyclophosphamide in adults with relapsed sarcoma." Sarcoma 2012:749067. , PMID: 22851904

Novartis Australian Product information Hycamtin 29 August 2019 https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05311-3&d=20220426172310101 (Accessed 11 November 2022)

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.