International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2026
Effectiveness and safety of prophylactic low-dose methotrexate in high-risk hydatidiform mole for preventing post-molar gestational trophoblastic neoplasia: a prospective comparative study from Myanmar.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Soe Htun Lynn, Htun Kyi Thar, Thinn Myint Myint, Tun Nwe Mar
Аннотация
OBJECTIVES: To evaluate the effectiveness and safety of prophylactic low-dose methotrexate in preventing progression to gestational trophoblastic neoplasia in women with high-risk hydatidiform mole.
METHODS: A prospective comparative study was conducted from March 2021 to February 2023 at hospitals affiliated with the University of Medicine-1, Yangon, Myanmar. Women with high-risk hydatidiform mole were enrolled using pre-defined clinical criteria. After evacuation, treatment allocation was determined by patient preference: 51 received intra-muscular methotrexate (0.4 mg/kg/day for 5 days), and 51 were managed expectantly. All patients underwent serial serum β-human chorionic gonadotropin monitoring for six months. Multi-variable logistic regression was performed to adjust for potential confounders.
RESULTS: A total of 102 women were included. Baseline characteristics were comparable between groups; mean age was 31.1 ± 10.3 years in the prophylactic group and 35.5 ± 10.1 years in the control group, and complete hydatidiform mole accounted for 60.8% and 64.7% of cases, respectively. Progression to gestational trophoblastic neoplasia occurred in 11/51 patients (21.6%) in the prophylactic group compared with 31/51 patients (60.8%) in the control group (p <.001). Prophylactic methotrexate was independently associated with reduced gestational trophoblastic neoplasia progression (adjusted odds ratio 0.16, 95% confidence interval 0.06 to 0.42, p <.001). Treatment-related adverse events occurred in 31/51 patients (60.8%), most commonly elevated liver enzymes (39.3%), fatigue (41.2%), and mucositis (37.3%), predominantly Common Terminology Criteria for Adverse Events grade 1 to 2. One patient developed grade 3 pancytopenia and recovered fully with supportive care. No grade 4 events or treatment-related deaths occurred.
CONCLUSION: Prophylactic low-dose methotrexate was associated with a reduced risk of gestational trophoblastic neoplasia in women with high-risk hydatidiform mole. Given the non-randomized, preference-based design, these findings should be interpreted with caution. Selective use in carefully chosen high-risk patients may be beneficial, particularly in settings where reliable follow-up is limited.
METHODS: A prospective comparative study was conducted from March 2021 to February 2023 at hospitals affiliated with the University of Medicine-1, Yangon, Myanmar. Women with high-risk hydatidiform mole were enrolled using pre-defined clinical criteria. After evacuation, treatment allocation was determined by patient preference: 51 received intra-muscular methotrexate (0.4 mg/kg/day for 5 days), and 51 were managed expectantly. All patients underwent serial serum β-human chorionic gonadotropin monitoring for six months. Multi-variable logistic regression was performed to adjust for potential confounders.
RESULTS: A total of 102 women were included. Baseline characteristics were comparable between groups; mean age was 31.1 ± 10.3 years in the prophylactic group and 35.5 ± 10.1 years in the control group, and complete hydatidiform mole accounted for 60.8% and 64.7% of cases, respectively. Progression to gestational trophoblastic neoplasia occurred in 11/51 patients (21.6%) in the prophylactic group compared with 31/51 patients (60.8%) in the control group (p <.001). Prophylactic methotrexate was independently associated with reduced gestational trophoblastic neoplasia progression (adjusted odds ratio 0.16, 95% confidence interval 0.06 to 0.42, p <.001). Treatment-related adverse events occurred in 31/51 patients (60.8%), most commonly elevated liver enzymes (39.3%), fatigue (41.2%), and mucositis (37.3%), predominantly Common Terminology Criteria for Adverse Events grade 1 to 2. One patient developed grade 3 pancytopenia and recovered fully with supportive care. No grade 4 events or treatment-related deaths occurred.
CONCLUSION: Prophylactic low-dose methotrexate was associated with a reduced risk of gestational trophoblastic neoplasia in women with high-risk hydatidiform mole. Given the non-randomized, preference-based design, these findings should be interpreted with caution. Selective use in carefully chosen high-risk patients may be beneficial, particularly in settings where reliable follow-up is limited.