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Nivolumab versusDocetaxel in AdvancedSquamous-CellNon–Small-Cell LungCancer Julie R. BrahmerKaren L. ReckampPaul Baas2015 год

Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer
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Аннотация: Patients with advanced squamous-cell non-small-cell lung cancer (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options. This randomized, open-label, international, phase 3 study evaluated the efficacy and safety of nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, as compared with docetaxel in this patient population.We randomly assigned 272 patients to receive nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, or docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks. The primary end point was overall survival.The median overall survival was 9.2 months (95% confidence interval [CI], 7.3 to 13.3) with nivolumab versus 6.0 months (95% CI, 5.1 to 7.3) with docetaxel. The risk of death was 41% lower with nivolumab than with docetaxel (hazard ratio, 0.59; 95% CI, 0.44 to 0.79; P<0.001). At 1 year, the overall survival rate was 42% (95% CI, 34 to 50) with nivolumab versus 24% (95% CI, 17 to 31) with docetaxel. The response rate was 20% with nivolumab versus 9% with docetaxel (P=0.008). The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel (hazard ratio for death or disease progression, 0.62; 95% CI, 0.47 to 0.81; P<0.001). The expression of the PD-1 ligand (PD-L1) was neither prognostic nor predictive of benefit. Treatment-related adverse events of grade 3 or 4 were reported in 7% of the patients in the nivolumab group as compared with 55% of those in the docetaxel group.Among patients with advanced, previously treated squamous-cell NSCLC, overall survival, response rate, and progression-free survival were significantly better with nivolumab than with docetaxel, regardless of PD-L1 expression level. (Funded by Bristol-Myers Squibb; CheckMate 017 ClinicalTrials.gov number, NCT01642004.).
Год издания: 2015
Авторы: Julie R. Brahmer, Karen L. Reckamp, Paul Baas, Lucio Crinó, Wilfried Eberhardt, Elena Poddubskaya, Scott Antonia, Adam Płużański, Everett E. Vokes, Esther Holgado, David Waterhouse, Neal Ready, Justin F. Gainor, Osvaldo Arén Frontera, Libor Havel, Martin Steins, Marina Chiara Garassino, Joachim G.J.V. Aerts, Manuel Dómine, Luís Paz-Ares, Martin Reck, Christine Baudelet, Christopher Harbison, Brian Lestini, David R. Spigel
Издательство: Massachusetts Medical Society
Источник: New England Journal of Medicine
Ключевые слова: Cancer Immunotherapy and Biomarkers, Lung Cancer Treatments and Mutations, Lung Cancer Research Studies
Другие ссылки: New England Journal of Medicine (PDF)
New England Journal of Medicine (HTML)
Europe PMC (PubMed Central) (PDF)
Europe PMC (PubMed Central) (HTML)
PubMed Central (HTML)
PubMed (HTML)