Abstract
7283 Purpose: The combination chemotherapy of irinotecan and cisplatin has been previously reported to be effective in the treatment of extensive-disease small-cell lung cancer (ED-SCLC). We conducted a phase II trial of the combination chemotherapy of irinotecan and carboplatin in replace of cisplatin in untreated ED-SCLC to evaluate the efficacy and toxicities. Methods: From Jan. 2003 to Aug. 2004, 24 patients (pts) with previously untreated ED-SCLC were enrolled. Pts were treated with irinotecan (50mg/m2 i.v. on day 1, 8 and 15) and carboplatin (target AUC=5 i.v. on day 1) every 4 weeks for up to 6 cycles. Results: The pts characteristics were as follows: median age 63 yrs (range, 39–72 yrs), ECOG PS 0–1/2 13/9, male/female 22/2. Median 5 cycles of chemotherapy (range, 1–6 cycles) and total 105 cycles was given to pts. Twenty one pts were assessable for response and toxicity. The median follow-up duration was 8months (range, 4–23 months). By intent-to-treat analysis the overall response rate was 75% (1 CR, 17 PR and 3 PD). The median time to progression was 6 months (95% CI: 4–7months). The median response duration and overall survival time was not reached. Major toxicityis was myelosuppression. G3/G4 neutropenia and thrombocytopenia occurred in 12.4% and 6%, respectively. G3/4 non-hematoloic toxicities included diarrhea (3%), infection (2%) and nausea (3%). There was one treatment-related death because of superimposed infection on bronchopleural fistula. Conclusion: The combination chemotherapy of irinotecan and carboplatin was effective and tolerable in ED-SCLC. No significant financial relationships to disclose.
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