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Treatment-free survival and partitioned survival analysis of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib: 5-year update of CheckMate 214.
Mantia, Charlene M; Jegede, Opeyemi A; Plimack, Elizabeth R; Powles, Thomas; Motzer, Robert J; Tannir, Nizar M; Lee, Chung-Han; Tomita, Yoshihiko; Voss, Martin H; Choueiri, Toni K; Rini, Brian I; Hammers, Hans J; Escudier, Bernard; Albigès, Laurence; Rosenblatt, Lisa; Atkins, Michael B; Regan, Meredith M; McDermott, David F.
Afiliação
  • Mantia CM; Harvard Medical School, Boston, Massachussetts, USA.
  • Jegede OA; Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
  • Plimack ER; Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
  • Powles T; Department of Hematology/Oncology, Fox Chase Cancer Center, Temple Health, Philadelphia, Pennsylvania, USA.
  • Motzer RJ; Department of Urology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, UK.
  • Tannir NM; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
  • Lee CH; Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
  • Tomita Y; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
  • Voss MH; Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
  • Choueiri TK; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
  • Rini BI; Harvard Medical School, Boston, Massachussetts, USA.
  • Hammers HJ; Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
  • Escudier B; Department of Medicine, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.
  • Albigès L; Division of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
  • Rosenblatt L; Department of Medical Oncology, Gustave Roussy, Villejuif, France.
  • Atkins MB; Department of Cancer Medicine, Gustave Roussy, Villejuif, France.
  • Regan MM; Bristol Myers Squibb, Princeton, New Jersey, USA.
  • McDermott DF; Georgetown-Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA.
J Immunother Cancer ; 12(7)2024 Jul 25.
Article em En | MEDLINE | ID: mdl-39060019
ABSTRACT

BACKGROUND:

Immunotherapy can be associated with prolonged disease control even after cessation of treatment without the need for further cancer-directed therapy. Treatment-related adverse events (TRAEs) can also persist after discontinuation of therapy. Treatment-free survival (TFS) with and without toxicity as a component of a partitioned survival model can characterize patient survival time, which is not captured by standard outcome measures.

METHODS:

Data from 1096 patients with advanced renal cell carcinoma treated with first-line nivolumab plus ipilimumab (NIVO+IPI) versus sunitinib (SUN) in the CheckMate 214 trial were analyzed. TFS was defined as the area between two Kaplan-Meier curves for time from randomization to protocol therapy discontinuation and time from randomization to subsequent systemic therapy initiation or death, estimated as the difference in 60-month restricted mean times with confidence intervals (CIs) obtained using bootstrap sampling. Time on protocol therapy and TFS were further characterized as time with and without grade 2+ and 3+TRAEs. Survival functions were estimated in subgroups including International Metastatic Renal Cell Carcinoma Database Consortium risk groups using the Kaplan-Meier method.

RESULTS:

At 5 years from randomization, 48% of patients treated with NIVO+IPI and 37% of patients treated with SUN were alive. In the intent-to-treat population, 18% of the NIVO+IPI-treated and 5% of SUN-treated patients are surviving treatment-free. For favorable-risk patients, the 60-month mean TFS was 14.4 months for NIVO+IPI versus 5.5 months for SUN (difference 8.9 months (95% CI 4.9 to 12.8)). TFS for NIVO+IPI versus SUN with grade 2+TRAEs was 5.0 and 2.1 months, respectively, and with grade 3+TRAEs was 1.2 and 0.3 months, respectively. For intermediate/poor-risk patients, the 60-month mean TFS was 10.1 months for NIVO+IPI versus 4.1 months for SUN (difference 6.1 months (95% CI 4.2 to 7.9)). TFS for NIVO+IPI versus SUN with grade 2+TRAEs was 4.0 versus 2.0 months, respectively, and 0.6 versus 0.3 months with grade 3+TRAEs.

CONCLUSIONS:

Although overall survival was similar, favorable-risk patients treated with NIVO+IPI spent more time surviving treatment-free with and without toxicity versus SUN after 60 months of follow-up. Intermediate/poor-risk patients treated with NIVO+IPI had longer survival and longer TFS without toxicity versus SUN. TRIAL REGISTRATION NUMBER NCT02231749.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Carcinoma de Células Renais / Protocolos de Quimioterapia Combinada Antineoplásica / Ipilimumab / Sunitinibe / Nivolumabe / Neoplasias Renais Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Immunother Cancer Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Carcinoma de Células Renais / Protocolos de Quimioterapia Combinada Antineoplásica / Ipilimumab / Sunitinibe / Nivolumabe / Neoplasias Renais Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Immunother Cancer Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Estados Unidos