Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer

Julie Brahmer, Karen L. Reckamp, Paul Baas, Lucio Crinò, Wilfried E E Eberhardt, Elena Poddubskaya, Scott Antonia, Adam Pluzanski, Everett E. Vokes, Esther Holgado, David Waterhouse, Neal Ready, Justin Gainor, Osvaldo Arén Frontera, Libor Havel, Martin Steins, Marina C. Garassino, Joachim G. Aerts, Manuel Domine, Luis Paz-AresMartin Reck, Christine Baudelet, Christopher T. Harbison, Brian Lestini, David R. Spigel

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)123-135
Number of pages13
JournalNew England Journal of Medicine
Volume373
Issue number2
DOIs
StatePublished - Jul 9 2015

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docetaxel
Non-Small Cell Lung Carcinoma
Epithelial Cells
Confidence Intervals
Survival
Body Surface Area
Disease Progression
Immunoglobulin G
Body Weight
Safety
Drug Therapy
nivolumab
Antibodies
Population

ASJC Scopus subject areas

  • Medicine(all)

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Brahmer, J., Reckamp, K. L., Baas, P., Crinò, L., Eberhardt, W. E. E., Poddubskaya, E., ... Spigel, D. R. (2015). Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. New England Journal of Medicine, 373(2), 123-135. https://doi.org/10.1056/NEJMoa1504627

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 journalArticle

Brahmer, J, Reckamp, KL, Baas, P, Crinò, L, Eberhardt, WEE, Poddubskaya, E, Antonia, S, Pluzanski, A, Vokes, EE, Holgado, E, Waterhouse, D, Ready, N, Gainor, J, Frontera, OA, Havel, L, Steins, M, Garassino, MC, Aerts, JG, Domine, M, Paz-Ares, L, Reck, M, Baudelet, C, Harbison, CT, Lestini, B & Spigel, DR 2015, 'Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer', New England Journal of Medicine, vol. 373, no. 2, pp. 123-135. https://doi.org/10.1056/NEJMoa1504627
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. / Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 2. pp. 123-135.
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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

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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

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