PMID- 26028407
OWN - NLM
STAT- MEDLINE
DCOM- 20150716
LR  - 20220420
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Print)
IS  - 0028-4793 (Linking)
VI  - 373
IP  - 2
DP  - 2015 Jul 9
TI  - Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.
PG  - 123-35
LID - 10.1056/NEJMoa1504627 [doi]
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<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. CONCLUSIONS: 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.).
FAU - Brahmer, Julie
AU  - Brahmer J
AD  - From the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore 
      (J.B.); the City of Hope Comprehensive Cancer Center, Duarte, CA (K.L.R.); the 
      Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam 
      (P.B.), Erasmus MC Cancer Institute, Rotterdam (J.G.A.), and Ziekenhuis Amphia, 
      Breda (J.G.A.) - all in the Netherlands; the University Hospital of Perugia, 
      Perugia (L.C.), and the Fondazione IRCCS Istituto Nazionale dei Tumori, Milan 
      (M.C.G.) - both in Italy; the Department of Medical Oncology, West German Cancer 
      Center, Universitatsklinikum Essen, and the Ruhrlandklinik, Universitat 
      Duisburg-Essen, Essen (W.E.E.E.), the Thoraxklinik, Heidelberg University 
      Hospital, Heidelberg (M.S.), and the LungenClinic Grosshansdorf, Grosshansdorf 
      (M.R.) - all in Germany; the N.N. Blokhin Russian Cancer Research Center, Moscow 
      (E.P.); the H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 
      (S.A.); the Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie, Warsaw, 
      Poland (A.P.); the University of Chicago Medicine and Biological Sciences, 
      Chicago (E.E.V.); the Hospital Madrid Norte Sanchinarro (E.H.), the Hospital 
      Universitario Fundacion Jimenez Diaz, Madrid (M.D.), and the Hospital 
      Universitario Virgen Del Rocio, Seville (L.P.-A.) - all in Spain; Oncology 
      Hematology Care, Cincinnati (D.W.); the Duke University Medical Center, Durham, 
      NC (N.R.); Massachusetts General Hospital, Boston (J.G.); Centro Internacional de 
      Estudios Clinicos, Santiago, Chile (O.A.F.); Nemocnice Na Bulovce, Prague, Czech 
      Republic (L.H.); Bristol-Myers Squibb, Princeton, NJ (C.B., C.T.H., B.L.); and 
      the Sarah Cannon Research Institute and Tennessee Oncology, Nashville (D.R.S.).
FAU - Reckamp, Karen L
AU  - Reckamp KL
FAU - Baas, Paul
AU  - Baas P
FAU - Crino, Lucio
AU  - Crino L
FAU - Eberhardt, Wilfried E E
AU  - Eberhardt WE
FAU - Poddubskaya, Elena
AU  - Poddubskaya E
FAU - Antonia, Scott
AU  - Antonia S
FAU - Pluzanski, Adam
AU  - Pluzanski A
FAU - Vokes, Everett E
AU  - Vokes EE
FAU - Holgado, Esther
AU  - Holgado E
FAU - Waterhouse, David
AU  - Waterhouse D
FAU - Ready, Neal
AU  - Ready N
FAU - Gainor, Justin
AU  - Gainor J
FAU - Aren Frontera, Osvaldo
AU  - Aren Frontera O
FAU - Havel, Libor
AU  - Havel L
FAU - Steins, Martin
AU  - Steins M
FAU - Garassino, Marina C
AU  - Garassino MC
FAU - Aerts, Joachim G
AU  - Aerts JG
FAU - Domine, Manuel
AU  - Domine M
FAU - Paz-Ares, Luis
AU  - Paz-Ares L
FAU - Reck, Martin
AU  - Reck M
FAU - Baudelet, Christine
AU  - Baudelet C
FAU - Harbison, Christopher T
AU  - Harbison CT
FAU - Lestini, Brian
AU  - Lestini B
FAU - Spigel, David R
AU  - Spigel DR
LA  - eng
SI  - ClinicalTrials.gov/NCT01642004
GR  - P30 CA076292/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150531
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (CD274 protein, human)
RN  - 0 (Immunoglobulin G)
RN  - 0 (PDCD1 protein, human)
RN  - 0 (Programmed Cell Death 1 Receptor)
RN  - 0 (Taxoids)
RN  - 15H5577CQD (Docetaxel)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
CIN - Nat Rev Clin Oncol. 2015 Aug;12(8):436. PMID: 26122186
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/adverse effects/*therapeutic use
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - B7-H1 Antigen/*metabolism
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality
MH  - Carcinoma, Squamous Cell/drug therapy/mortality
MH  - Docetaxel
MH  - Female
MH  - Humans
MH  - Immunoglobulin G
MH  - Lung Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Nivolumab
MH  - Programmed Cell Death 1 Receptor/immunology
MH  - Survival Analysis
MH  - Taxoids/adverse effects/*therapeutic use
PMC - PMC4681400
MID - NIHMS739447
EDAT- 2015/06/02 06:00
MHDA- 2015/07/17 06:00
PMCR- 2016/07/09
CRDT- 2015/06/02 06:00
PHST- 2015/06/02 06:00 [entrez]
PHST- 2015/06/02 06:00 [pubmed]
PHST- 2015/07/17 06:00 [medline]
PHST- 2016/07/09 00:00 [pmc-release]
AID - 10.1056/NEJMoa1504627 [doi]
PST - ppublish
SO  - N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 
      31.