Antonio Braga1, Clymene de Souza Hartung Araújo2, Paulo Alexandre Ribeiro Mora3, Eduardo Paulino4, Andréia Cristina de Melo4, Guillermo Coca Velarde5, Ana Paula Vieira Dos Santos Esteves2, Joffre Amim Junior2, Jorge Rezende Filho2, Kevin M Elias6, Neil S Horowitz6, Ross S Berkowitz6. 1. Rio de Janeiro Trophoblastic Disease Center (Maternity School of Rio de Janeiro Federal University, Antonio Pedro University Hospital of Fluminense Federal University), Rio de Janeiro, RJ, Brazil; Postgraduate Program in Perinatal Health, Faculty of Medicine, Maternity School of Rio de Janeiro Federal University, Brazil; Postgraduate Program in Medical Sciences, Fluminense Federal University, Niterói, RJ, Brazil. Electronic address: antonio.braga@ufrj.br. 2. Rio de Janeiro Trophoblastic Disease Center (Maternity School of Rio de Janeiro Federal University, Antonio Pedro University Hospital of Fluminense Federal University), Rio de Janeiro, RJ, Brazil; Postgraduate Program in Perinatal Health, Faculty of Medicine, Maternity School of Rio de Janeiro Federal University, Brazil. 3. Rio de Janeiro Trophoblastic Disease Center (Maternity School of Rio de Janeiro Federal University, Antonio Pedro University Hospital of Fluminense Federal University), Rio de Janeiro, RJ, Brazil; Postgraduate Program in Medical Sciences, Fluminense Federal University, Niterói, RJ, Brazil; Brazilian National Cancer Institute, Hospital do Câncer 2, Rio de Janeiro, RJ, Brazil. 4. Brazilian National Cancer Institute, Hospital do Câncer 2, Rio de Janeiro, RJ, Brazil. 5. Postgraduate Program in Medical Sciences, Fluminense Federal University, Niterói, RJ, Brazil. 6. New England Trophoblastic Disease Center, Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Abstract
OBJECTIVE: To compare the outcomes of patients with low-risk gestational trophoblastic neoplasia (GTN) treated with standard 8-day methotrexate/folinic acid (MTX/FA) versus modified regimen. METHODS: Retrospective cohort study of patients with low-risk GTN followed at Rio de Janeiro Federal University, from January/1990-December/2017 with standard 8-day MTX/FA or modified regimen (MTX administered on the 8th day rather than 7th) to avoid treatment on the weekend. RESULTS: From 937 patients with low-risk GTN, 538 were treated with standard MTX/FA and 98 patients received modified regimen. Both groups were comparable in age (p = .749), antecedent pregnancy (p = .221), time to initiate chemotherapy (p = .926), hCG pretreatment level (p = .112) and WHO/FIGO prognostic risk score (p = .723). Patients treated with modified MTX/FA had twice of cases of metastatic lung disease compared with the standard regimen (22.5% vs 10.6%; p = .002). The rate of remission (p = .999), number of cycles to remission in the first-line (p = .966), chemoresistance (p = .500), time to switch to second-line therapy (p = .176), need for multiagent chemotherapy (p = .084), relapse (p = .122) or death (p = .475) was the same for both MTX/FA regimen. However, although patients receiving modified MTX/FA required a higher total number of remission cycles (6 vs 5 cycles; p = .004) and longer time to remission (19 vs 16 weeks; p < .001) when compared with the standard regimen, these variables showed no significant differences after multivariate logistic regression adjusted for lung metastasis. CONCLUSION: The modified 8-day MTX/FA regimen didn't compromise oncologic outcomes for women with low-risk GTN. This regimen appears to be an acceptable alternative to standard 8-day MTX/FA when treatment on weekend isn't an option.
OBJECTIVE: To compare the outcomes of patients with low-risk gestational trophoblastic neoplasia (GTN) treated with standard 8-day methotrexate/folinic acid (MTX/FA) versus modified regimen. METHODS: Retrospective cohort study of patients with low-risk GTN followed at Rio de Janeiro Federal University, from January/1990-December/2017 with standard 8-day MTX/FA or modified regimen (MTX administered on the 8th day rather than 7th) to avoid treatment on the weekend. RESULTS: From 937 patients with low-risk GTN, 538 were treated with standard MTX/FA and 98 patients received modified regimen. Both groups were comparable in age (p = .749), antecedent pregnancy (p = .221), time to initiate chemotherapy (p = .926), hCG pretreatment level (p = .112) and WHO/FIGO prognostic risk score (p = .723). Patients treated with modified MTX/FA had twice of cases of metastatic lung disease compared with the standard regimen (22.5% vs 10.6%; p = .002). The rate of remission (p = .999), number of cycles to remission in the first-line (p = .966), chemoresistance (p = .500), time to switch to second-line therapy (p = .176), need for multiagent chemotherapy (p = .084), relapse (p = .122) or death (p = .475) was the same for both MTX/FA regimen. However, although patients receiving modified MTX/FA required a higher total number of remission cycles (6 vs 5 cycles; p = .004) and longer time to remission (19 vs 16 weeks; p < .001) when compared with the standard regimen, these variables showed no significant differences after multivariate logistic regression adjusted for lung metastasis. CONCLUSION: The modified 8-day MTX/FA regimen didn't compromise oncologic outcomes for women with low-risk GTN. This regimen appears to be an acceptable alternative to standard 8-day MTX/FA when treatment on weekend isn't an option.