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Nivolumab vs docetaxel in previously treated patients with advanced non–small-cell lung cancer: Two-year outcomes from two randomized, open-label, phase III trials (CheckMate 017 and CheckMate 057)

Journal of Clinical Oncology Dec 22, 2017

Horn L, et al. - Researchers pursued a comparative scrutiny of the efficacy of nivolumab and docetaxel in previously treated patients with advanced non–small-cell lung cancer. The findings unveiled long-term clinical benefit and a favorable tolerability profile of nivolumab compared with docetaxel in the study cohort.

Methods

  • The eligible candidates included patients with stage IIIB/IV squamous (N = 272) or nonsquamous (N = 582) NSCLC and disease progression during or after prior platinum-based chemotherapy.
  • Enrollees were randomly assigned 1:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m2 every 3 weeks).
  • It was noted that the minimum follow-up for survival was 24.2 months.

Results

  • Researchers illustrated that the two-year overall survival rates with nivolumab vs docetaxel were 23% (95% CI, 16% to 30%) vs 8% (95% CI, 4% to 13%) in squamous NSCLC and 29% (95% CI, 24% to 34%) vs 16% (95% CI, 12% to 20%) in nonsquamous NSCLC.
  • Similar relative reductions were revealed between the risk of death with nivolumab vs docetaxel and those reported in the primary analyses.
  • Nivolumab presented durable responses; 10 (37%) of 27 confirmed responders with squamous NSCLC and 19 (34%) of 56 with nonsquamous NSCLC exhibited ongoing responses after 2 years’ minimum follow-up.
  • Ongoing response was not obtained from any patient in either docetaxel group.
  • Pooled analysis demonstrated that the relative reduction in the risk of death with nivolumab vs docetaxel was 28% (hazard ratio, 0.72; 95% CI, 0.62 to 0.84).
  • Experts exhibited lower rates of treatment-related adverse events with nivolumab than with docetaxel (any grade, 68% v 88%; grade 3 to 4, 10% v 55%).

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