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Systemic Anti-Cancer Therapy Regimen Library

Home > GYN GTD - EMA-CO [etoposide, metHOTREXATe, daCTINomycin, CYCLOPHOSPHamide and vinCRISTine] [high risk]

GYN GTD - EMA-CO [etoposide, metHOTREXATe, daCTINomycin, CYCLOPHOSPHamide and vinCRISTine] [high risk]

Treatment Overview

Continuous for 3 cycles beyond normal ß-hCG.


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.

Cycle 1 (and all further cycles) - 14 days

Cycle length:
14

Filgrastim duration: Only two days treatment may be needed with initial cycles (i.e., given on Days 3 and 4, and Days 9 and 10).

Cycle details

Cycle 1 (and all further cycles) - 14 days

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1 to 4,
8, 9, 10
ondansetron 8 mg oral administration 1, 2, 8
sodium chloride 0.9 % intravenous 1 60 minutes
daCTINomycin 0.5 mg flat dosing intravenous 1, 2 5 minutes
etoposide (as phosphate) * 100 mg/m² intravenous 1, 2 60 minutes
metHOTREXATe * 300 mg/m² intravenous 1 12 hours
sodium chloride 0.9 % intravenous 1 60 minutes
foliNIc acid (as calcium folinate) * 15 mg flat dosing Twice daily oral administration 2, 3
filgrastim 5 microgram/kg Once daily subcutaneous injection 3, 4, 5,
9, 10, 11
vinCRISTine 1 mg/m² Cap dose per administration at: 2 mg intravenous 8 10 minutes
CYCLOPHOSPHamide 600 mg/m² intravenous 8 60 minutes
ondansetron 8 mg oral administration 1, 2, 8
docusate sodium + sennoside B 2 Tablet(s) oral administration 1
domperidone 10 mg Three times daily oral administration 1

Filgrastim duration: Only two days treatment may be needed with initial cycles (i.e., given on Days 3 and 4, and Days 9 and 10).

Full details

Cycle 1 (and all further cycles) - 14 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.
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:
Prior to chemotherapy. Ensure patient has passed urine as per institutional policy.
daCTINomycin 0.5 mg flat dosing intravenous 5 minutes
Instructions:
Warning vesicant–ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
etoposide (as phosphate) * 100 mg/m² intravenous 60 minutes
metHOTREXATe * 300 mg/m² intravenous 12 hours
sodium chloride 0.9 % intravenous 60 minutes
Quantity:1000 mL
Instructions:
After metHOTREXATe infusion. Ensure patient has passed urine as per institutional policy.
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.
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.
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.

Day: 2

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.
daCTINomycin 0.5 mg flat dosing intravenous 5 minutes
Instructions:
Warning vesicant–ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
etoposide (as phosphate) * 100 mg/m² intravenous 60 minutes
foliNIc acid (as calcium folinate) * 15 mg flat dosing Twice daily oral administration
Instructions:
Every 12 hours for 4 doses commencing 24 hours after the start of metHOTREXATe infusion. Take each dose on an empty stomach - one hour before OR two hours after food.
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.
foliNIc acid (as calcium folinate) * 15 mg flat dosing Twice daily oral administration
Instructions:
Every 12 hours for 4 doses commencing 24 hours after the start of metHOTREXATe infusion. Take each dose on an empty stomach - one hour before OR two hours after food.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

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.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
This dose may not be required with initial cycles. Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 8

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.
vinCRISTine 1 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
Warning vesicant–ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
CYCLOPHOSPHamide 600 mg/m² intravenous 60 minutes
ondansetron 8 mg oral administration
Instructions:
EIGHT hours after chemotherapy OR before bed.

Day: 9

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.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 10

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.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 11

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
This dose may not be required with initial cycles. Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Supportive Care Factors

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

References

LaCasce, Ann S. 2010. "Therapeutic use of high-dose methotrexate." In UpToDate 18.3 Edition. https://www.uptodate.com/contents/therapeutic-use-and-toxicity-of-high-dose-methotrexate

Newlands, E. S., K. D. Bagshawe, R. H. Begent, et al. 1991. "Results with the EMA/CO (etoposide, methotrexate, actinomycin D, cyclophosphamide, vincristine) regimen in high risk gestational trophoblastic tumours, 1979 to 1989." Br.J.Obstet.Gynaecol. 98(6):550-557., PMID: 1651757

Turan, T., O. Karacay, G. Tulunay, et al. 2006. "Results with EMA/CO (etoposide, methotrexate, actinomycin D, cyclophosphamide, vincristine) chemotherapy in gestational trophoblastic neoplasia." Int.J.Gynecol.Cancer. 16(3):1432-1438., PMID: 16803542

Quinn, M., J. Murray, M. Friedlander, et al. 1994. "EMACO in high risk gestational trophoblast disease--the Australian experience. Gestational Trophoblast Subcommittee, Clinical Oncological Society of Australia." Aust N.Z.J Obstet.Gynaecol. 34(1):90-92., PMID: 8053886

Bower, M., E. S. Newlands, L. Holden, et al. 1997. "EMA/CO for high-risk gestational trophoblastic tumors: results from a cohort of 272 patients." J Clin Oncol. 15(7):2636-2643., PMID: 9215835

Escobar, P. F., J. R. Lurain, D. K. Singh, et al. 2003. "Treatment of high-risk gestational trophoblastic neoplasia with etoposide, methotrexate, actinomycin D, cyclophosphamide, and vincristine chemotherapy." Gynecol.Oncol. 91(3):552-557., PMID: 14675675

Lurain, J. R. 1998. "Management of high-risk gestational trophoblastic disease." J.Reprod.Med. 43(1):44-52., PMID: 9475149

Lurain, J. R. 2002. "Advances in management of high-risk gestational trophoblastic tumors." J.Reprod.Med. 47(6):451-459., PMID: 12092013

Lurain, J. R., D. K. Singh and J. C. Schink. 2006. "Primary treatment of metastatic high-risk gestational trophoblastic neoplasia with EMA-CO chemotherapy." J Reprod.Med. 51(10):767-772., PMID: 17086804

Mangili, G., D. Lorusso, J. Brown, et al. 2014. "Trophoblastic disease review for diagnosis and management: a joint report from the International Society for the Study of Trophoblastic Disease, European Organisation for the Treatment of Trophoblastic Disease, and the Gynecologic Cancer InterGroup." Int J Gynecol Cancer 24(9 Suppl 3):S109-116., PMID: 25341573

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.