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Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma.
Motzer, Robert J; Hutson, Thomas E; Tomczak, Piotr; Michaelson, M Dror; Bukowski, Ronald M; Oudard, Stéphane; Negrier, Sylvie; Szczylik, Cezary; Pili, Roberto; Bjarnason, Georg A; Garcia-Del-Muro, Xavier; Sosman, Jeffrey A; Solska, Ewa; Wilding, George; Thompson, John A; Kim, Sindy T; Chen, Isan; Huang, Xin; Figlin, Robert A.
Afiliação
  • Motzer RJ; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Hutson TE; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Tomczak P; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Michaelson MD; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Bukowski RM; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Oudard S; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Negrier S; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Szczylik C; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Pili R; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Bjarnason GA; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Garcia-Del-Muro X; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Sosman JA; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Solska E; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Wilding G; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Thompson JA; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Kim ST; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Chen I; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Huang X; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
  • Figlin RA; From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University,
J Clin Oncol ; 41(11): 1965-1971, 2023 04 10.
Article em En | MEDLINE | ID: mdl-37018919
ABSTRACT

PURPOSE:

A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-α) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported. PATIENTS AND

METHODS:

Seven hundred fifty treatment-naïve patients with metastatic clear cell RCC were randomly assigned to sunitinib 50 mg orally once daily on a 4 weeks on, 2 weeks off dosing schedule or to IFN-α 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. Progression-free survival, response, and safety end points were assessed with updated follow-up.

RESULTS:

Median overall survival was greater in the sunitinib group than in the IFN-α group (26.4 v 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P = .051) per the primary analysis of unstratified log-rank test (P = .013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P = .049). Within the IFN-α group, 33% of patients received sunitinib, and 32% received other vascular endothelial growth factor-signaling inhibitors after discontinuation from the trial. Median progression-free survival was 11 months for sunitinib compared with 5 months for IFN-α (P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN-α (P < .001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%).

CONCLUSION:

Sunitinib demonstrates longer overall survival compared with IFN-α plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Prognostic_studies Idioma: En Ano de publicação: 2023 Tipo de documento: Article