Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
Grantová podpora
P30 CA076292
NCI NIH HHS - United States
PubMed
26028407
PubMed Central
PMC4681400
DOI
10.1056/nejmoa1504627
Knihovny.cz E-zdroje
- MeSH
- analýza přežití MeSH
- antigeny CD274 metabolismus MeSH
- antigeny CD279 imunologie MeSH
- antitumorózní látky škodlivé účinky terapeutické užití MeSH
- docetaxel MeSH
- dospělí MeSH
- imunoglobulin G MeSH
- lidé středního věku MeSH
- lidé MeSH
- monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- nádory plic farmakoterapie mortalita MeSH
- nemalobuněčný karcinom plic farmakoterapie mortalita MeSH
- nivolumab MeSH
- senioři MeSH
- spinocelulární karcinom farmakoterapie mortalita MeSH
- taxoidy škodlivé účinky terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- antigeny CD274 MeSH
- antigeny CD279 MeSH
- antitumorózní látky MeSH
- CD274 protein, human MeSH Prohlížeč
- docetaxel MeSH
- imunoglobulin G MeSH
- monoklonální protilátky MeSH
- nivolumab MeSH
- PDCD1 protein, human MeSH Prohlížeč
- taxoidy MeSH
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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ClinicalTrials.gov
NCT01642004