TY - JOUR
T1 - Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma
T2 - 42-Month Results of the CheckMate 214 Trial
AU - Regan, Meredith M.
AU - Jegede, Opeyemi A.
AU - Mantia, Charlene M.
AU - Powles, Thomas
AU - Werner, Lillian
AU - Motzer, Robert J.
AU - Tannir, Nizar M.
AU - Lee, Chung Han
AU - Tomita, Yoshihiko
AU - Voss, Martin H.
AU - Plimack, Elizabeth R.
AU - Choueiri, Toni K.
AU - Rini, Brian I.
AU - Hammers, Hans J.
AU - Escudier, Bernard
AU - Albiges, Laurence
AU - Huo, Stephen
AU - Del Tejo, Viviana
AU - Stwalley, Brian
AU - Atkins, Michael B.
AU - McDermott, David F.
N1 - Publisher Copyright:
© 2021 The Authors.
PY - 2021/12/15
Y1 - 2021/12/15
N2 - 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. 3.7months).MeanTFSwith grade ≥3 TRAEs was a small proportion of time for both treatments (0.6 vs. 0.3 months after nivolumab plus ipilimumab vs. sunitinib for intermediate/ poor-risk, and 0.9 vs. 0.3months 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.
AB - 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. 3.7months).MeanTFSwith grade ≥3 TRAEs was a small proportion of time for both treatments (0.6 vs. 0.3 months after nivolumab plus ipilimumab vs. sunitinib for intermediate/ poor-risk, and 0.9 vs. 0.3months 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.
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Carcinoma, Renal Cell/pathology
KW - Humans
KW - Immune Checkpoint Inhibitors
KW - Ipilimumab/adverse effects
KW - Kidney Neoplasms/pathology
KW - Sunitinib/therapeutic use
UR - http://www.scopus.com/inward/record.url?scp=85119257748&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000732485700001&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1158/1078-0432.CCR-21-2283
DO - 10.1158/1078-0432.CCR-21-2283
M3 - Article
C2 - 34759043
SN - 1078-0432
VL - 27
SP - 6687
EP - 6695
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 24
ER -