The addition of ipilimumab to etoposide and a platinum agent failed to prolong overall survival, when contrasted with chemotherapy only, for patients with extensive-stage small cell lung cancer (SCLC), a study published in the Journal of Clinical Oncology has shown.1
Patients with extensive-stage SCLC have poor survival outcomes despite the use of etoposide and a platinum agent as first-line therapy; researchers evaluated the efficacy and safety of adding ipilimumab to that regimen in newly diagnosed patients in this phase 3 trial.
For this double-blind study, investigators enrolled 1132 patients and randomly assigned them 1:1 to receive chemotherapy with etoposide and cisplatin or carboplatin, plus ipilimumab 10 mg/kg or placebo every 3 weeks for a total of 4 doses.
Among the 954 patients who received at least 1 dose of study therapy, median overall survival was 11.0 months with chemoimmunotherapy, compared with 10.9 months for chemotherapy plus placebo (hazard ratio, 0.94; 95% CI, 0.81-1.09; P = .3775).
Median progression-free survival was 4.6 months and 4.4 months for chemotherapy plus ipilimumab and chemotherapy plus placebo, respectively (hazard ratio, 0.85; 95% CI, 0.75-0.97).
Treatment-related adverse events were similar between the 2 groups, though diarrhea, rash, and colitis occurred more frequently in the ipilimumab group.
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Eighteen percent of patients in the ipilimumab arm discontinued treatment due to toxicities, versus 2% in the placebo arm. Five patients treated with ipilimumab died; 2 died in the placebo group; these deaths were treatment-related.
- Reck M, Luft A, Szczesna A, et al. Phase III randomized trial of ipilimumab plus etoposide and platinum versus placebo plus etoposide and platinum in extensive-stage small-cell lung cancer. J Clin Oncol. 2016 Jul 25. doi: 10.1200/JCO.2016.67.6601 [Epub ahead of print]