Izildinha Maestá1, Roni Nitecki2, Neil S Horowitz3, Donald P Goldstein3, Marjory de Freitas Segalla Moreira4, Kevin M Elias3, Ross S Berkowitz3. 1. Department of Gynecology and Obstetrics, Botucatu Medical School, UNESP-Sao Paulo State University, Botucatu, SP, Brazil; Trophoblastic Diseases Center of the Botucatu Medical School, UNESP-Sao Paulo State University, Botucatu, SP, Brazil; Postgraduate Program of Gynecology, Obstetrics and Mastology of Botucatu Medical School, UNESP-São Paulo State University, Botucatu, SP, Brazil.. Electronic address: imaesta@fmb.unesp.br. 2. Department of Obstetrics and Gynecology, Brigham and Women's Hospital Boston, MA, USA. 3. Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Brigham and Women's Hospital, Boston, MA, USA; New England Trophoblastic Disease Center, Donald P. Goldstein M.D. Tumor Registry, Boston, MA, USA; Dana Farber Cancer Institute/Harvard Cancer Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. 4. Department of Gynecology and Obstetrics, Botucatu Medical School, UNESP-Sao Paulo State University, Botucatu, SP, Brazil; Trophoblastic Diseases Center of the Botucatu Medical School, UNESP-Sao Paulo State University, Botucatu, SP, Brazil; Postgraduate Program of Gynecology, Obstetrics and Mastology of Botucatu Medical School, UNESP-São Paulo State University, Botucatu, SP, Brazil.
Abstract
OBJECTIVES: To assess the outcomes and toxicity of first-line methotrexate (MTX) chemotherapy in low-risk postmolar gestational trophoblastic neoplasia (GTN) patients receiving 8-day methotrexate or one-day methotrexate infusion regimens. METHODS: This retrospective cohort study was conducted at the New England Trophoblastic Disease Center (NETDC), between 1974 and 2014, and included 325 patients with FIGO-defined low-risk postmolar GTN receiving first-line 8-day MTX/folinic acid (FA) or one-day MTX infusion and FA. Demographics, disease presentation, initial treatment plan, treatment outcome, and treatment-related adverse events were assessed. RESULTS: Sustained remission (84% vs 62%, p<0.001) and need to switch to second-line therapy due to treatment-related adverse events (5.3% vs 0%, p=0.001) were higher for 8-day MTX/FA compared to one-day MTX infusion. MTX resistance, however, was more frequent with one-day MTX (34.5%) than with 8-day MTX/FA (7.3%, p<0.001). Relapse rates were similar with both regimens (3.0%). Compared to one-day MTX infusion, 8-day MTX/FA was associated with significantly higher gastrointestinal disorders (48% vs 24%), abnormal laboratory findings (48% vs 28%), eye disorders (37% vs 19%) and general disorders (22% vs 5%) (p<0.001). Only infection frequency did not differ between 8-day MTX/FA and one-day MTX infusion (20% vs 12%, p=0.083). CONCLUSIONS: This is one of the largest studies to comprehensively catalogue toxicities associated with 8-day MTX/FA and one-day MTX infusion. Although treatment-related adverse events were more frequent with 8-day MTX/FA, these were all self-limited and resolved with no long-term sequelae. Given this and its higher effectiveness, 8-day MTX/FA remains the treatment of choice at NETDC for patients with low-risk postmolar GTN.
OBJECTIVES: To assess the outcomes and toxicity of first-line methotrexate (MTX) chemotherapy in low-risk postmolar gestational trophoblastic neoplasia (GTN) patients receiving 8-day methotrexate or one-day methotrexate infusion regimens. METHODS: This retrospective cohort study was conducted at the New England Trophoblastic Disease Center (NETDC), between 1974 and 2014, and included 325 patients with FIGO-defined low-risk postmolar GTN receiving first-line 8-day MTX/folinic acid (FA) or one-day MTX infusion and FA. Demographics, disease presentation, initial treatment plan, treatment outcome, and treatment-related adverse events were assessed. RESULTS: Sustained remission (84% vs 62%, p<0.001) and need to switch to second-line therapy due to treatment-related adverse events (5.3% vs 0%, p=0.001) were higher for 8-day MTX/FA compared to one-day MTX infusion. MTX resistance, however, was more frequent with one-day MTX (34.5%) than with 8-day MTX/FA (7.3%, p<0.001). Relapse rates were similar with both regimens (3.0%). Compared to one-day MTX infusion, 8-day MTX/FA was associated with significantly higher gastrointestinal disorders (48% vs 24%), abnormal laboratory findings (48% vs 28%), eye disorders (37% vs 19%) and general disorders (22% vs 5%) (p<0.001). Only infection frequency did not differ between 8-day MTX/FA and one-day MTX infusion (20% vs 12%, p=0.083). CONCLUSIONS: This is one of the largest studies to comprehensively catalogue toxicities associated with 8-day MTX/FA and one-day MTX infusion. Although treatment-related adverse events were more frequent with 8-day MTX/FA, these were all self-limited and resolved with no long-term sequelae. Given this and its higher effectiveness, 8-day MTX/FA remains the treatment of choice at NETDC for patients with low-risk postmolar GTN.