Abstract
BACKGROUND 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. METHODS 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. RESULTS 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
| Original language | English (US) |
|---|---|
| Pages (from-to) | 123-135 |
| Number of pages | 13 |
| Journal | New England Journal of Medicine |
| Volume | 373 |
| Issue number | 2 |
| DOIs | |
| State | Published - Jul 9 2015 |
Fingerprint
ASJC Scopus subject areas
- Medicine(all)
Cite this
Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. / Brahmer, Julie; Reckamp, Karen L.; Baas, Paul; Crinò, Lucio; Eberhardt, Wilfried E E; Poddubskaya, Elena; Antonia, Scott; Pluzanski, Adam; Vokes, Everett E.; Holgado, Esther; Waterhouse, David; Ready, Neal; Gainor, Justin; Frontera, Osvaldo Arén; Havel, Libor; Steins, Martin; Garassino, Marina C.; Aerts, Joachim G.; Domine, Manuel; Paz-Ares, Luis; Reck, Martin; Baudelet, Christine; Harbison, Christopher T.; Lestini, Brian; Spigel, David R.
In: New England Journal of Medicine, Vol. 373, No. 2, 09.07.2015, p. 123-135.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer
AU - Brahmer, Julie
AU - Reckamp, Karen L.
AU - Baas, Paul
AU - Crinò, Lucio
AU - Eberhardt, Wilfried E E
AU - Poddubskaya, Elena
AU - Antonia, Scott
AU - Pluzanski, Adam
AU - Vokes, Everett E.
AU - Holgado, Esther
AU - Waterhouse, David
AU - Ready, Neal
AU - Gainor, Justin
AU - Frontera, Osvaldo Arén
AU - Havel, Libor
AU - Steins, Martin
AU - Garassino, Marina C.
AU - Aerts, Joachim G.
AU - Domine, Manuel
AU - Paz-Ares, Luis
AU - Reck, Martin
AU - Baudelet, Christine
AU - Harbison, Christopher T.
AU - Lestini, Brian
AU - Spigel, David R.
PY - 2015/7/9
Y1 - 2015/7/9
N2 - BACKGROUND 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. METHODS 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. RESULTS 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
AB - BACKGROUND 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. METHODS 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. RESULTS 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
UR - http://www.scopus.com/inward/record.url?scp=84936791837&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84936791837&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1504627
DO - 10.1056/NEJMoa1504627
M3 - Article
C2 - 26028407
AN - SCOPUS:84936791837
VL - 373
SP - 123
EP - 135
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 2
ER -