The addition of ipilimumab to etoposide and a platinum agent failed to demonstrate improved survival in patients with extensive-stage small-cell lung cancer when compared with chemotherapy alone, a study published in the Journal of Clinical Oncology has shown.
Despite first-line chemotherapy with etoposide and platinum, survival outcomes for patients with extensive-stage small-cell lung cancer still have poor outcomes. Thus, researchers led by Martin Reck, MD, PhD, LurgenClinic Grosshansdorf, Germany, conducted a randomized, double-blind phase III study comparing the safety and efficacy of adding ipilimumab or a placebo to etoposide and platinum treatment in patients with extensive-stage small-cell lung cancer.
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A total of 1132 patients were randomly assigned to received ipilumumab 10 mg/kg or placebo every 3 weeks for a total of four doses each in a phased induction schedule followed by ipilimumab or placebo maintenance every 12 weeks. The primary endpoint was overall survival, though researchers also looked at the rates and severity of treatment-related adverse events.
At analysis, 954 patients received at least one dose of study therapy (chemotherapy plus ipilimumab, n = 478; chemotherapy plus placebo, n = 476). Overall survival in those who received ipilimumab was 11 months compared with 10.9 months for those who were treated with chemotherapy plus placebo, indicating no significant difference between the two modalities. Similarly, progression-free survival was 4.6 months and 4.4 months in these same patients, respectively.
Treatment-related adverse events were also similar between the two treatment arms, except for diarrhea, rash, and colitis, which were reported more frequently in those who received ipilimumab. Additionally, there were 5 treatment-related deaths among those receiving ipilimumab and only 2 in the placebo group.
Researchers concluded that the addition of ipilimumab to etoposide and a platinum agent did not improve survival compared with chemotherapy alone in patients with newly diagnosed extensive-stage small cell lung cancer. Other studies are currently underway evaluating the benefit of ipilimumab in combination with programmed death-1 inhibitors.
