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Regan, Meredith M.; Jegede, Opeyemi A.; Mantia, Charlene M.; Powles, Thomas; Werner, Lillian; Motzer, Robert J.; Tannir, Nizar M.; Lee, Chung-Han; Tomita, Yoshihiko; Voss, Martin H.; Plimack, Elizabeth R.; Choueiri, Toni K.; Rini, Brian I.; Hammers, Hans J.; Escudier, Bernard; Albiges, Laurence; Huo, Stephen; Del Tejo, Viviana; Stwalley, Brian; Atkins, Michael B.; McDermott, David F.

Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial

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  • Medientyp: E-Artikel
  • Titel: Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial
  • Beteiligte: Regan, Meredith M.; Jegede, Opeyemi A.; Mantia, Charlene M.; Powles, Thomas; Werner, Lillian; Motzer, Robert J.; Tannir, Nizar M.; Lee, Chung-Han; Tomita, Yoshihiko; Voss, Martin H.; Plimack, Elizabeth R.; Choueiri, Toni K.; Rini, Brian I.; Hammers, Hans J.; Escudier, Bernard; Albiges, Laurence; Huo, Stephen; Del Tejo, Viviana; Stwalley, Brian; Atkins, Michael B.; McDermott, David F.
  • Erschienen: American Association for Cancer Research (AACR), 2021
  • Erschienen in: Clinical Cancer Research, 27 (2021) 24, Seite 6687-6695
  • Sprache: Englisch
  • DOI: 10.1158/1078-0432.ccr-21-2283
  • ISSN: 1078-0432; 1557-3265
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: 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-naïve, 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. 0.3 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.
  • Zugangsstatus: Freier Zugang