Phase II study of a 3-week schedule of irinotecan combined with cisplatin in previously untreated extensive-stage small-cell lung cancer.

BACKGROUND: Irinotecan has been introduced to improve the treatment of small-cell lung cancer (SCLC). We conducted a trial involving a 3-week schedule of irinotecan combined with cisplatin (IP) to validate the efficacy and toxicity of this regimen in patients with previously untreated extensive-stage SCLC (ES-SCLC). PATIENTS AND METHODS: Twenty-eight patients with previously untreated ES-SCLC were enrolled in the study between January 2003 and December 2005. Irinotecan 60 mg/m(2) was administered intravenously on days 1 and 8 in combination with cisplatin 60 mg/m(2) on day 1 every 21 days. RESULTS: Twenty-eight patients were followed until July 2007. The median follow-up time was 15.6 months. The actual dose intensities (DIs) of cisplatin and irinotecan were 97.7 and 92.2%, respectively. Among the 28 ES-SCLC patients, the objective response rate was 89.3% (25 patients). The major grade 3/4 hematological toxicity was neutropenia (26.9% of cycles). Grade 3/4 non-hematological toxicities were rare. The median progression-free and overall survival times were 8.7 and 16.5 months, with a 1-year survival rate of 66.6% and 2-year survival rate of 22.2%. CONCLUSION: The 3-week schedule of IP was feasible and showed a high DI of irinotecan and decreased toxicity.