A multicenter randomized phase II study of the irinotecan/gemcitabine doublet versus irinotecan monotherapy in previously treated patients with extensive stage small-cell lung cancer

ObjectivesTo compare the efficacy and safety profile of irinotecan (I) versus the combination of irinotecan/gemcitabine (IG) as second-line treatment of patients with extensive stage small-cell lung cancer (SCLC).TreatmentPatients with SCLC who have received at least one chemotherapy regimen were randomized to receive either the IG regimen (gemcitabine 1000 mg/m2 intravenous (i.v.) on days 1 and 8 and irinotecan 300 mg/m2 i.v. on day 8) or I monotherapy (300 mg/m2 i.v. on day 1) both every 3 weeks.ResultsThirty-eight patients were enrolled in the IG and 31 in the I arm. Due to slow accrual an early closure of the study was decided. Response rate was significantly higher in the IG than in I arm (23.7% vs. 0%; p = 0.004). The median time to progression (TTP) was 3.9 months (range: 0.5–14.5 months; 95% CI: 1.4–6.6) and 1.7 months (range: 0.5–9.9 months; 95% CI: 1.2–2.3) (p = 0.010) for the IG and I arms, respectively. There was no difference in terms of median overall survival between the two arms (6.8 months and 4.6 months for the IG and I arm, respectively). The most frequent toxicities were grade III/IV neutropenia and grade III/IV diarrhea.ConclusionsAlthough the IG regimen seems to be more active than the I monotherapy, the premature closure of the study prevents the drawing of definitive conclusions.