Randomized Phase III Trial of Irinotecan Plus Cisplatin Versus Etoposide Plus Cisplatin in Chemotherapy-Naïve Korean Patients with Extensive-Disease Small Cell Lung Cancer.

Purpose: This randomized phase III study was designed to compare the efficacy and safety of irinotecan plus cisplatin (IP) over etoposide plus cisplatin (EP) in Korean patients with extensive-disease small-cell lung cancer (SCLC).

Materials and Methods: Patients were randomly assigned to receive IP, composed of irinotecan 65 mg/m2 intravenously on days 1 and 8 + cisplatin 70 mg/m2 intravenously on day1 every 3 weeks, or EP, composed of etoposide 100 mg/m2 intravenously on days 1, 2, 3+cisplatin 70 mg/m2 intravenously on day 1, every 3 weeks for a maximum of six cycles, until disease progression, or until unacceptable toxicity occurred. The primary endpoint was overall survival.

Results: A total of 362 patients were randomized to IP (n=173) and EP (n=189) arms. There were no significant differences between IP and EP arms for the median overall survival (10.9 vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 vs. 5.8 months, p=0.1125). However, there was a significant difference in response rate (62.4 vs. 48.2%, p=0.0064). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 vs. 10.1 months, p=0.0361), <65 years old (12.7 vs. 11.3 months, p=0.0240), and ECOG performance status 0/1 (12.4 vs. 10.9 months, p=0.0407) patient groups. The severity of treatment-related adverse events such as grade 3/4 anemia, nausea and diarrhea was more frequent in patients treated with IP.

Conclusion: The IP chemotherapy did not significantly improve the survival compared with EP chemotherapy in Korean patients with extensive-disease SCLC. (ClinicalTrials.gov Identifier: NCT00349492).