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Treatment-free survival: A novel outcome measure of the effects of immune checkpoint inhibition—A pooled analysis of patients with advanced melanoma

Journal of Clinical Oncology Sep 18, 2019

Regan MM, Werner L, Rao S, et al. - Researchers sought to determine the outcome measures that comprehensively capture attributes of immuno-oncology agents, including prolonged treatment-free time and persistent treatment-related adverse events (TRAEs), in order to complement conventional survival endpoints. From the CheckMate 067 and 069 clinical trials of nivolumab and ipilimumab, as monotherapies or in combination, for patients with advanced melanoma, data were obtained for this work. Among the 1,077 patients who initiated ICI therapy, many were alive at 36 months with no subsequent therapy initiation (47% nivolumab plus ipilimumab, 37% nivolumab, 15% ipilimumab). Nivolumab plus ipilimumab vs nivolumab or ipilimumab led to longer restricted mean treatment-free survival (TFS) (11.1 months vs 4.6 months vs 8.7 months) without toxicity among patients with advanced melanoma. A small proportion of the TFS involved grade 3 or higher TRAEs regardless of treatment.
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