Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia: a gynecologic oncology group study.
OBJECTIVE
There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN).


METHODS
Two commonly used single-drug regimens were compared with respect to the proportion of patients meeting the criteria for a complete response (CR) in a randomized phase III trial conducted by the Gynecologic Oncology Group. Eligibility was purposefully broad to maximize the generalizability of the results and included patients with a WHO risk score of 0 to 6 and patients with metastatic disease (limited to lung lesions < 2 cm, adnexa, or vagina) or choriocarcinoma.


RESULTS
Two hundred forty women were enrolled, and 216 were deemed eligible. Biweekly intravenous dactinomycin 1.25 mg/m² was statistically superior to weekly intramuscular (IM) methotrexate 30 mg/m² (CR: 70% v 53%; P = .01). Similarly, in patients with low-risk GTN as defined before the 2002 WHO risk score revisions (risk score of 0 to 4 and excluding choriocarcinoma), response was 58% and 73% in the methotrexate and dactinomycin arms, respectively (P = .03). Both regimens were less effective if the WHO risk score was 5 or 6 or if the diagnosis was choriocarcinoma (CR: 9% and 42%, respectively). There were two potential recurrences; one at 4 months (dactinomycin) and one at 22 months (methotrexate). Not all patients completed follow-up. Both regimens were well tolerated.


CONCLUSIONS
The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.
Odette Cancer Centre, Toronto, Ontario, Canada. ray.osborne@sunnybrook.ca
Raymond J
RJ
Osborne
Virginia
V
Filiaci
Julian C
JC
Schink
Robert S
RS
Mannel
Angeles
A
Alvarez Secord
Joseph L
JL
Kelley
Diane
D
Provencher
David
D
Scott Miller
Allan L
AL
Covens
Janice M
JM
Lage
D000328:Adult; D001707:Biopsy, Needle; D002822:Choriocarcinoma / Q000188:drug therapy / Q000473:pathology; D003609:Dactinomycin / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D031901:Gestational Trophoblastic Disease / Q000188:drug therapy* / Q000473:pathology*; D006801:Humans; D007150:Immunohistochemistry; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D016015:Logistic Models; D020714:Maximum Tolerated Dose; D008495:Medical Oncology; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D009367:Neoplasm Staging; D016017:Odds Ratio; D009864:Ontario; D011247:Pregnancy; D020551:Pulse Therapy, Drug; D016896:Treatment Outcome; D055815:Young Adult
D003609:Dactinomycin; D008727:Methotrexate
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