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Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer

Cancer Mar 05, 2020

Lee YC, Wang L, Kohn EC, et al. - Given the possibility of increased risk for adverse events (AEs) in women with gynecologic cancer due to peritoneal disease burden and prior treatment (surgery, chemotherapy, and pelvic radiotherapy), researchers here compared patients with and without gynecologic cancer enrolled in phase 1 trials in terms of their toxicity profiles. In this retrospective analysis, they assessed the National Cancer Institute phase 1 database for all trials enrolling 1 or more patients with gynecologic cancer over 2 decades (1995-2015). They identified enrollment of a total of 4,269 patients (median age: 58 years) in 150 trials; these patients were divided into 3 groups: 1) women with gynecologic cancer (n = 685), 2) women with nongynecologic cancer (n = 1698), and 3) men with cancer (n = 1,886). During treatment, highest mean number of total AEs were reported in women with gynecologic cancer, and this supports providing attention to their symptom burden. They recommend considering study dose management for recurrent grade 2 AEs, especially during continuous therapy.
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