Treatment-Related Adverse Events and Associated Outcomes in Patients With Advanced Urothelial Carcinoma Treated With Enfortumab Vedotin: Analysis of the UNITE Study.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
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Nizam Amanda, Nguyen Charles B, Li Jinju, Zabor Emily C, Msaouel Pavlos, Jiang Cindy Y, Alhalabi Omar, Oh Eugene, Davidsohn Matthew P, Epstein Ilana B, Bakaloudi Dimitra Rafailia, Talukder Rafee, Jindal Tanya, Taylor Amy K, Glover Michael J, Khaki Ali Raza, Lemke Emily, Mabey Hannah, Abuqayas Bashar, Jang Albert, Brown Jason R, Evans Sean T, Pywell Cameron, Basu Arnab, Bilen Mehmet A, Barata Pedro C, Zakharia Yousef, Milowsky Matthew I, Kilari Deepak, Hoimes Christopher J, Shah Sumit A, Emamekhoo Hamid, Davis Nancy B, Gupta Shilpa, Grivas Petros, Bellmunt Joaquim, Campbell Matthew T, Alva Ajjai S, Koshkin Vadim S
Аннотация
MATERIALS AND METHODS: UNITE is a multicenter, retrospective study across 16 US sites of patients with aUC treated with targeted agents, including EV. Primary endpoints were the incidence of EV treatment-related adverse events (TRAEs, any grade) and TRAE-related treatment modifications. Secondary endpoints included a comparison of ORR, progression-free survival (PFS), and overall survival (OS) between patients with and without dermatologic toxicities and neuropathy. To reduce immortal time bias, Cox regression models incorporated TRAEs as time-dependent covariates to adjust for EV treatment duration as well as Eastern Cooperative Oncology Group performance status (ECOG PS), hemoglobin, and liver metastases.
RESULTS: Between 2018 and 2023, 485 patients with aUC received > 1 dose of EV monotherapy. Most (67%) received > 2 prior therapy lines. Any grade TRAEs occurred in 77%, most frequently neuropathy (36%) and dermatologic toxicities (27%); 57% required treatment modification and 21% discontinued EV, primarily due to neuropathy (9%) and fatigue (3%). Patients with dermatologic toxicities and neuropathy had higher ORR (56% vs. 42%; p = 0.007 and 64% vs. 35%; p < 0.0001, respectively). Neuropathy was independently associated with improved OS (HR 0.66; 95% CI 0.50-0.87; p = 0.002); dermatologic TRAEs were not associated with PFS or OS benefit.
CONCLUSIONS: EV safety outside clinical trials was consistent with prior reports, with no new signals. Treatment modifications were most often due to neuropathy, dermatologic toxicities, and fatigue. Both dermatologic toxicities and neuropathy correlated with higher ORR, but only neuropathy was independently associated with improved OS.