Title |
Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer
|
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Published in |
New England Journal of Medicine, September 2015
|
DOI | 10.1056/nejmoa1507643 |
Pubmed ID | |
Authors |
Hossein Borghaei, Luis Paz-Ares, Leora Horn, David R Spigel, Martin Steins, Neal E Ready, Laura Q Chow, Everett E Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhäufl, Oscar Arrieta, Marco Angelo Burgio, Jérôme Fayette, Hervé Lena, Elena Poddubskaya, David E Gerber, Scott N Gettinger, Charles M Rudin, Naiyer Rizvi, Lucio Crinò, George R Blumenschein, Scott J Antonia, Cécile Dorange, Christopher T Harbison, Friedrich Graf Finckenstein, Julie R Brahmer |
Abstract |
Background Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity. Methods In this randomized, open-label, international phase 3 study, we assigned patients with nonsquamous non-small-cell lung cancer (NSCLC) that had progressed during or after platinum-based doublet chemotherapy 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. Results Overall survival was longer with nivolumab than with docetaxel. The median overall survival was 12.2 months (95% confidence interval [CI], 9.7 to 15.0) among 292 patients in the nivolumab group and 9.4 months (95% CI, 8.1 to 10.7) among 290 patients in the docetaxel group (hazard ratio for death, 0.73; 96% CI, 0.59 to 0.89; P=0.002). At 1 year, the overall survival rate was 51% (95% CI, 45 to 56) with nivolumab versus 39% (95% CI, 33 to 45) with docetaxel. With additional follow-up, the overall survival rate at 18 months was 39% (95% CI, 34 to 45) with nivolumab versus 23% (95% CI, 19 to 28) with docetaxel. The response rate was 19% with nivolumab versus 12% with docetaxel (P=0.02). Although progression-free survival did not favor nivolumab over docetaxel (median, 2.3 months and 4.2 months, respectively), the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel (19% and 8%, respectively). Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression (≥1%, ≥5%, and ≥10%) of the PD-1 ligand. Treatment-related adverse events of grade 3 or 4 were reported in 10% of the patients in the nivolumab group, as compared with 54% of those in the docetaxel group. Conclusions Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy, overall survival was longer with nivolumab than with docetaxel. (Funded by Bristol-Myers Squibb; CheckMate 057 ClinicalTrials.gov number, NCT01673867 .). |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Japan | 65 | 21% |
United States | 18 | 6% |
Spain | 15 | 5% |
United Kingdom | 8 | 3% |
Mexico | 3 | <1% |
Canada | 3 | <1% |
Germany | 2 | <1% |
Brazil | 2 | <1% |
Italy | 2 | <1% |
Other | 10 | 3% |
Unknown | 180 | 58% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 275 | 89% |
Practitioners (doctors, other healthcare professionals) | 18 | 6% |
Scientists | 14 | 5% |
Science communicators (journalists, bloggers, editors) | 1 | <1% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 7 | <1% |
Spain | 6 | <1% |
Japan | 4 | <1% |
Brazil | 3 | <1% |
France | 3 | <1% |
Italy | 2 | <1% |
Netherlands | 2 | <1% |
Germany | 2 | <1% |
United Kingdom | 2 | <1% |
Other | 4 | <1% |
Unknown | 3114 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 524 | 17% |
Student > Ph. D. Student | 384 | 12% |
Other | 300 | 10% |
Student > Bachelor | 298 | 9% |
Student > Master | 264 | 8% |
Other | 593 | 19% |
Unknown | 786 | 25% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 1164 | 37% |
Biochemistry, Genetics and Molecular Biology | 326 | 10% |
Agricultural and Biological Sciences | 203 | 6% |
Pharmacology, Toxicology and Pharmaceutical Science | 130 | 4% |
Immunology and Microbiology | 127 | 4% |
Other | 268 | 9% |
Unknown | 931 | 30% |