Adverse effects of methotrexate in gestational trophoblastic neoplasia treatment

Objective: Identify the incidence and related factors of elevated transaminases in low-risk gestational trophoblastic disease patients treated with methotrexate. Methods: Prospective cohort. 163 patients were recruited with low-risk gestational trophoblastic disease, treated with methotrexate and folinic acid, from October 2019 to June 2020 at Tu Du hospital. Kaplan-Meier survival analysis is performed to determine the incidence of elevated transaminases over time. We apply Cox regression model in order to identify factors related to elevated transaminases and build a Nomogram to predict the risk of elevated transaminases. Results: The incidence of elevated transaminases is 28.83%. Out of 47 cases of elevated transaminases, 16 cases occurred after 1 cycle of treatment, 14 cases occurred after 2 cycles and 9 cases appeared after 3 cycles, and after 4, 5, and 6 cycles, there were only 4, 2, 1 cases of elevated transaminases, respectively. There were no cases after treatment cycle eighth and ninth. In patients with pre-treatment aspartate aminotransferase (AST)> 25 UI/L, the risk of elevated transaminases is 2.29 times higher than in patience with pre-treatment AST < 25 UI/L. Based on Cox regression model, we built a Nomogram with 4 variables, including age, body mass index (BMI), pre-treatment AST, and pre-treatment alanine aminotransferase (ALT). Conclusions: The overall incidence of elevated transaminases is 28.83%, usually occurred within the first 3 to 4 treatment cycle. Pre-treatment AST is related to elevated transaminases.