Home-based and hospital-based 8-day methotrexate/folinic acid chemotherapy for low-risk gestational trophoblastic neoplasia: a comparison of outcomes at two tertiary referral centers

Abstract

Low-risk gestational trophoblastic neoplasia (GTN) can be effectively treated by chemotherapy with a single agent, which is usually methotrexate (MTX) associated with folinic acid (FA) as it is less toxic than MTX or actinomycin D alone. There are no studies comparing treatment outcomes among regional centers with different socioeconomic characteristics and different treatment settings. Objectives: To compare the outcomes of low-risk postmolar GTN between two regional tertiary referral centers that provide MTX/folinic acid treatment in two different settings (home-based versus hospital-based). Methods: Multiple cohort studies including women with low-risk GTN treated with first-line 8-day MTX/FA at the New England Trophoblastic Disease Center (NETDC) and at the Botucatu Trophoblastic Diseases Center, Universidade Estadual Paulista (BTDC), between 2002 and 2020. Independent variable: cohort source (NETDC or BTDC). Potentially confounding variables: age at diagnosis, hydatiform mole histological type (complete/partial), pre-treatment hCG (IU/L), FIGO risk score. Outcomes: The effectiveness of treatment with MTX/FA, home versus institutional hospital, will be evaluated by analyzing the occurrence of GTN complete response, resistance, and relapse; and the safety of the treatments will be evaluated by the development of adverse events to MTX graded according to the Toxicity Criteria (CTCAE, version 5.0). Comparison between cohorts will be made by fitting Poisson, multiple regression models.(AU)