Ipilimumab with paclitaxel and carboplatin as first-line therapy in extensive disease small cell lung cancer

This study investigated the effects of ipilimumab (Yervoy) in combination with chemotherapy in the treatment of extensive disease small-cell lung cancer (ED-SCLC).

Ipilimumab is a drug used to modify the behavior of the immune system. Ipilimumab acts against regulatory immune cells (cells that inhibit the action of certain components of the immune system). Removing this inhibition allows the immune system to attack cancer cells. Ipilimumab has already been approved for treatment of advanced melanoma patients, and has shown promising results.

This early phase trial examined whether ipilimumab could also benefit lung cancer patients when given in combination with chemotherapy. The manner in which these treatments should be combined was also under investigation. 

130 patients diagnosed with ED-SCLC were randomized into 3 groups. Patients in the control group received chemotherapy and a placebo. The remaining patients received chemotherapy and ipilimumab in two alternative regimens. The concurrent ipilimumab group received ipilimumab and chemotherapy combined, followed by chemotherapy treatment alone. The phased ipilimumab group received chemotherapy treatment alone, followed by combined ipilimumab and chemotherapy treatment.

Results showed that phased ipilimumab, but not concurrent ipilimumab, improved progression free survival (PFS; the time until the disease progresses or worsens after treatment) compared to chemotherapy treatment alone. PFS was 6.4 months in the phased ipilimumab group compared to 5.3 months in the control group. Overall survival was 12.9 months in the phased ipilimumab group compared to 9.9 months in the control group. However, the increase in overall survival did not prove to be statistically significant. In addition, both the phased and concurrent ipilimumab treatments showed higher rates of serious adverse effects compared to the control group.

In conclusion, this early phase trial showed that ipilimumab was a viable treatment option for extensive disease small-cell lung cancer patients. Ipilimumab may increase survival warranting further larger studies.

This study was an early phase trial, aimed at providing initial data on the effect and most beneficial dosages of the drug. A phase III trial is currently underway to verify ipilimumab's clinical benefits. This study was sponsored by Bristol-Myers Squibb, the manufactures of ipilimumab (yervoy).