Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
This Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
First line therapy for the treatment of high risk GTD
|DACTINomycin||0.5 mg||IV||Days 1 and 2|
|etoposide||100 mg /m²||IV||Days 1 and 2|
|methotrexate||100 mg /m²||IV||Day 1 ONLY|
|methotrexate||200 mg /m²||IV continuous infusion over 12 hrs||Day 1 ONLY|
|leucovorin||15 mg||PO||Every 6 hrs x 4 doses|
|cyclophosphamide||600 mg /m²||IV||Day 8|
|vinCRIStine||1 mg /m²||IV (maximum 2 mg)||Day 8|
REPEAT EVERY 14 DAYS
(EMA and CO are alternated at weekly intervals starting with EMA)
Treatment continued for 2-4 cycles past the first normal hCG level.
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
Berkowitz RS, Goldstein DP. Current management of gestational trophoblastic diseases. Gynecol Oncol 2009;112(3):654-62.
Bower M, Newlands ES, et al. EMA-CO for high-risk gestational trophoblastic tumors: results from a cohort of 272 patients. J Clin Oncol 1997 Jul; 15(7): 2636-43.
Escobar PF, Lurain JR, Singh DK, et al. Treatment of high-risk gestational trophoblastic neoplasia with etoposide, methotrexate, actinomycin D, cyclophosphamide, and vincristine chemotherapy. Gynecol Oncol 2003;91(3):552-7.
Lybol C, Thomas CM, Blanken EA, et al. Comparing cisplatin-based combination chemotherapy with EMA/CO chemotherapy for the treatment of high risk gestational trophoblastic neoplasia. Eur J Cancer 2013;49(4):860-7.
McNeish IA, Strickland S, Holden L, et al. Low-risk persistent gestational trophoblastic disease: outcome after initial treatment with low-dose methotrexate and folinic acid from 1992 to 2000. J Clin Oncol 2002;20(7):1838-44.
Newlands ES, et al, VP-16 in combination for first-line treatment of malignant germ-cell tumours and gestational choriocarcinoma. Semin Oncol, 1985; 12 (Suppl 12): 37-41
Princess Margaret Cancer Centre Clinical Practice Guidelines: Gynecologic Cancer (Gestational Trophoblastic Disease), July 2015.
Quinn M, Murray J, Friedlander M, et al. EMACO in high risk gestational trophoblast disease - the Australian experience. Aust NZ J Obstet Gynaecol 1994;34:90-2.
Society of Gynecologists and Obstetricians of Canada Clinical Practice Guidelines: Gestational Trophoblastic Disease.
June 2019 Updated emetic risk category
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
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