The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.
Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer
Open accessAbstract
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.).
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In the citing paper
“Nivolumab has significantly improved outcomes in patients with metastatic non-small cell lung cancer (NSCLC); however, reliable prognostic biomarkers remain an unmet need.”
From SUVmax-IPI as a New Prognostic Index in Metastatic Non-Small Cell Lung Cancer Patients Receiving Nivolumab (2025) · cites this paper as [3]
Experimental — accuracy not yet measuredIn the citing paper
“The development of immune checkpoint inhibitors (ICI) targeting the PD-1/PD-L1 interaction has transformed the therapeutic landscape of patients with advanced non-small cell lung cancer (NSCLC) [1][2][3][4][5][6] .”
From Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer (2022) · cites this paper as [2]
In the citing paper
“Landmark trials performed on previously treated patients with advanced NSCLC demonstrated superior overall survival (OS) with PD-1/PD-L1 blockade compared to standard chemotherapy [1][2][3] .”
From Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer (2022) · cites this paper as [2]
In the citing paper
“Although PD-L1 expression on tumor cells was correlated with treatment efficacy in melanoma patients (67, 108), it was not in patients with squamous cell carcinoma, non-small cell lung cancer and Merkel cell carcinoma (70, 72, 74).”
From Anti-PD-1 and Anti-CTLA-4 Therapies in Cancer: Mechanisms of Action, Efficacy, and Limitations (2018) · cites this paper as [72]
In the citing paper
“At the data cut-off, median OS was 9.2 months (95% CI: 7.3-13.3months) on nivolumab compared with 6.0 months (95% CI: 5.1-7.3months) on docetaxel, with a 41% reduction in the risk of death in the nivolumab arm (HR 0.59, 95% CI: 0.44-0.49;P < 0.001).”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
In the citing paper
“The expression of PD-L1 was neither prognostic nor predictive of clinical benefit in a retrospective analysis using various cut points in this study.”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
In the citing paper
“A phase III trial (CheckMate 017) in patients previously treated for SCC compared 3 mg/kg of nivolumab given every 2 weeks with docetaxel, showing an improvement of 3.2 months [97,98]”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
In the citing paper
“In the phase III trial, nivolumab was better tolerated than docetaxel, with 85% of nivolumab patients receiving at least 90% of their planned dose intensity, compared with 69% of docetaxel patients, together with a treatment discontinuation rate of 10% versus 3% of the patients treated with nivolumab and docetaxel, respectively.”
From Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2016) · cites this paper as [98]
In the citing paper
“The primary end point was overall response rate, which occurred in 17 (14.5%) of 117 patients (95% CI 8.7 to 22.2).”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [98]
In the citing paper
“Median time to response was 3.3 months; median duration of response had not been reached at the time of publication.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [98]
In the citing paper
“Adverse effects included dyspnea, fatigue, pneumonitis, diarrhea, musculoskeletal pain, and severe immune-mediated adverse effects98,99; 59% of patients experienced serious adverse events.100”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [98]
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Metadata
- Authors
- Brahmer, J., Reckamp, K. L., Baas, P., Crinò, L., Eberhardt, W. E. E., Poddubskaya, E., Antonia, S., Pluzanski, A., Vokes, E. E., Holgado, E., Waterhouse, D., Ready, N., Gainor, J., Arén Frontera, O., Havel, L., Steins, M., Garassino, M. C., Aerts, J. G., Domine, M., Paz-Ares, L., Reck, M., Baudelet, C., Harbison, C. T., Lestini, B., & Spigel, D. R.
- Affiliations
- City Of Hope National Medical Center (US)
- The Netherlands Cancer Institute (NL)
- University of Perugia (IT)
- Ruhrlandklinik (DE)
- Russian Cancer Research Center NN Blokhin (RU)
- Moffitt Cancer Center (US)
- University of Chicago (US)
- Oncology Hematology Care (US)
- Duke Medical Center (US)
- Massachusetts General Hospital (US)
- Fakultní nemocnice Bulovka (CZ)
- University Hospital Heidelberg (DE)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- Amphia Ziekenhuis (NL)
- Hospital Universitario Virgen del Rocío (ES)
- LungenClinic Grosshansdorf (DE)
- Bristol-Myers Squibb (United States) (US)
- Tennessee Oncology (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-07-09
- Volume
- 373
- Issue
- 2
- Pages
- 123-135
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4681400
- OpenAlex
- W2156353875
- Cited by
- 8,447
- References
- 22
- Citations by year
- 2026: 204 · 2025: 332 · 2024: 525 · 2023: 627 · 2022: 718 · 2021: 928 · 2020: 1065 · 2019: 969 · 2018: 1066 · 2017: 1001 · 2016: 803 · 2015: 184
- FWCI
- 444.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Funders
- National Cancer Institute (P30CA076292)
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- nivolumab, docetaxel, squamous cell non-small cell lung cancer, PD-1 inhibitors, immune checkpoint inhibitors, overall survival, progression-free survival, PD-L1 expression, treatment-related adverse events, second-line therapy, previously treated patients, response rate, treatment safety and efficacy comparison, immunotherapy versus chemotherapy
- MeSH terms
- Docetaxel, Nivolumab, Adult, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Female, Humans, Immunoglobulin G, Lung Neoplasms, Male, Middle Aged, Survival Analysis, Taxoids, B7-H1 Antigen, Programmed Cell Death 1 Receptor
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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