Objective: To compare the efficacy of methotrexate and actinomycin D as single agents in first-line chemotherapy for women with low-risk gestational trophoblastic neoplasia (LR-GTN).
Methods: A total of 131 women with LR-GTN were randomized to receive a weekly pulsed dose of 30 mg/m(2) of methotrexate intramuscularly (n=81) or a pulsed intravenous bolus of 1.25 mg/m(2) of actinomycin D every 2 weeks (n=50). An additional cycle was administered as consolidation treatment following normalization of the serum level of beta-human chorionic gonadotropin (<5 IU/L).
Results: Complete remission was achieved in 48.14% of patients in the methotrexate group and 90.00% in the actinomycin D group (P<0.001). The mean number of treatment cycles needed to achieve response was lower in the actinomycin D group (4.8 vs 6.8). The risk of treatment failure was 26.4 greater with methotrexate than with actinomycin D (95% confidence interval, 5.7-22.6; P<0.001).
Conclusion: Actinomycin D may be a better option than methotrexate as a first-line chemotherapy agent for patients with LR-GTN.