Treatment-free survival after immune checkpoint inhibitor therapy versus targeted therapy for advanced renal cell carcinoma: 42-month results of the CheckMate 214 trial Journal Article

   

Authors:	Regan, M. M.; Jegede, O. A.; Mantia, C. M.; Powles, T.; Werner, L.; Motzer, R. J.; Tannir, N. M.; Lee, C. H.; Tomita, Y.; Voss, M. H.; Plimack, E. R.; Choueiri, T. K.; Rini, B. I.; Hammers, H. J.; Escudier, B.; Albiges, L.; Huo, S.; Del Tejo, V.; Stwalley, B.; Atkins, M. B.; McDermott, D. F.
Article Title:	Treatment-free survival after immune checkpoint inhibitor therapy versus targeted therapy for advanced renal cell carcinoma: 42-month results of the CheckMate 214 trial
Abstract:	Purpose: Patients discontinuing immuno-oncology regimens may experience periods of disease control without need for ongoing anticancer therapy, but toxicity may persist. We describe treatment-free survival (TFS), with and without toxicity. Patients and Methods: Data were analyzed from the randomized phase III CheckMate 214 trial of nivolumab plus ipilimumab (n = 550) versus sunitinib (n = 546) for treatment-naive, advanced renal cell carcinoma (aRCC). TFS was estimated by the 42-month restricted mean times defined by the area between Kaplan-Meier curves for two time-to-event endpoints defined from randomization: time to protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was subdivided as TFS with and without toxicity by counting days with >= 1 grade >= 3 treatment-related adverse event (TRAE). Results: At 42 months since randomization, 52% of nivolumab plus ipilimumab and 39% of sunitinib intermediate/poor-risk patients were alive; 18% and 5% surviving treatment-free, respectively. Among favorable-risk patients, 70% and 73% of nivolumab plus ipilimumab and sunitinib patients were alive; 20% and 9% treatment-free. Over the 42-month period, mean TFS was over twice as long after nivolumab plus ipilimumab than sunitinib for intermediate/poor-risk (6.9 vs. 3.1 months) and three times as long for favorable-risk patients (11.0 vs. 3.7 months). Mean TFS with grade >= 3 TRAEs was a small proportion of time for both treatments (0.6 vs. 03 months after nivolumab plus ipilimumab vs. sunitinib for intermediate/poor-risk, and 0.9 vs. 0.3 months for favorable-risk patients). Conclusions: Patients initiating first-line nivolumab plus ipilimumab for aRCC spent more survival time treatment-free without toxicity versus those on sunitinib, regardless of risk group.
Keywords:	interferon; sunitinib; ipilimumab; outcomes; cancer; combined nivolumab
Journal Title:	Clinical Cancer Research
Volume:	27
Issue:	24
ISSN:	1078-0432
Publisher:	American Association for Cancer Research
Date Published:	2021-12-15
Start Page:	6687
End Page:	6695
Language:	English
ACCESSION:	WOS:000732485700001
DOI:	10.1158/1078-0432.Ccr-21-2283
PROVIDER:	wos
PUBMED:	34759043
PMCID:	PMC9357269
Notes:	Article -- Source: Wos

https://synapse.mskcc.org/synapse/works/has_related_data_chk/191843