Annals of oncology : official journal of the European Society for Medical Oncology · 2025
Efficacy and safety of biweekly single-dose actinomycin D versus multiday methotrexate in low-risk gestational trophoblastic neoplasia: a prospective multicenter randomized trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Jiang F, Guan C L, Jiao L Z, Xu T, Wan X R, Shi S S, Wu B B, Zhang X, Zhen L, Miao J W, Tian M, Du M, Li C, Feng F Z, Yang J J, Ren T, Zhao J, Li Y, Zhang X Q, Lu X, Xiang Y
Аннотация
BACKGROUND: Cure rates for low-risk gestational trophoblastic neoplasia (GTN) are high, but there is no consensus on optimal first-line chemotherapy. Here we evaluated the efficacy and safety of biweekly single-dose actinomycin D (Act-D) versus an 8-day methotrexate (MTX)-folinic acid regimen as first-line single-agent chemotherapy for low-risk GTN.
PATIENTS AND METHODS: This multicenter, randomized, controlled trial enrolled patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-III, low-risk GTN (FIGO 2000 prognostic scores 0-4) across eight centers in China (ClinicalTrials.gov identifier: NCT04562558). Patients were randomized (1 : 1) to Act-D (1.25 mg/m2, maximum 2 mg, every 14 days) or MTX-folinic acid (50 mg i.m. days 1, 3, 5, and 7; leucovorin rescue, days 2, 4, 6, and 8). Treatment continued until β-human chorionic gonadotropin normalization, followed by 2-3 consolidation cycles. Primary outcomes were complete remission (CR) rates for single-agent chemotherapy and overall CR rates. Secondary outcomes were time to CR, chemotherapy cycles, toxicity, and anti-Müllerian hormone changes.
RESULTS: Between 27 September 2020, and 18 June 2024, 228 patients were randomized to MTX or Act-D. Act-D achieved significantly higher single-agent CR rates than MTX (72.8% versus 54.4%, P = 0.0038) with shorter median remission time (7.86 versus 9.43 weeks, P = 0.0296). Overall CR rates were 100% in both groups following combination chemotherapy for resistant cases. Most adverse events were grade 1-2, but grade ≥2 nausea and vomiting and hair loss were more frequent with Act-D, and alanine aminotransferase was more frequently elevated in the MTX group. Anti-Müllerian hormone reductions were transient in both groups. After a 28.5-month median follow-up, recurrence rates remained low and comparable (MTX 0.88% versus Act-D 0.88%; P > 0.05). Fertility outcomes were favorable in both groups.
CONCLUSIONS: Biweekly Act-D demonstrated superior efficacy and faster remission than the 8-day MTX regimen as first-line single-agent chemotherapy for low-risk GTN, offering a well-tolerated option despite a higher incidence of nausea, vomiting, and hair loss.
PATIENTS AND METHODS: This multicenter, randomized, controlled trial enrolled patients with International Federation of Gynecology and Obstetrics (FIGO) stage I-III, low-risk GTN (FIGO 2000 prognostic scores 0-4) across eight centers in China (ClinicalTrials.gov identifier: NCT04562558). Patients were randomized (1 : 1) to Act-D (1.25 mg/m2, maximum 2 mg, every 14 days) or MTX-folinic acid (50 mg i.m. days 1, 3, 5, and 7; leucovorin rescue, days 2, 4, 6, and 8). Treatment continued until β-human chorionic gonadotropin normalization, followed by 2-3 consolidation cycles. Primary outcomes were complete remission (CR) rates for single-agent chemotherapy and overall CR rates. Secondary outcomes were time to CR, chemotherapy cycles, toxicity, and anti-Müllerian hormone changes.
RESULTS: Between 27 September 2020, and 18 June 2024, 228 patients were randomized to MTX or Act-D. Act-D achieved significantly higher single-agent CR rates than MTX (72.8% versus 54.4%, P = 0.0038) with shorter median remission time (7.86 versus 9.43 weeks, P = 0.0296). Overall CR rates were 100% in both groups following combination chemotherapy for resistant cases. Most adverse events were grade 1-2, but grade ≥2 nausea and vomiting and hair loss were more frequent with Act-D, and alanine aminotransferase was more frequently elevated in the MTX group. Anti-Müllerian hormone reductions were transient in both groups. After a 28.5-month median follow-up, recurrence rates remained low and comparable (MTX 0.88% versus Act-D 0.88%; P > 0.05). Fertility outcomes were favorable in both groups.
CONCLUSIONS: Biweekly Act-D demonstrated superior efficacy and faster remission than the 8-day MTX regimen as first-line single-agent chemotherapy for low-risk GTN, offering a well-tolerated option despite a higher incidence of nausea, vomiting, and hair loss.