S-Space College of Medicine/School of Medicine (의과대학/대학원) Cancer Research Institute (암연구소) Journal Papers (저널논문_암연구소)
Randomized phase III trial of irinotecan plus cisplatin versus etoposide plus cisplatin in chemotherapy-naïve Korean patients with extensive-disease small cell lung cancer
- Kim, Dong-Wan; Kim, Hoon-Gu; Kim, Joo-Hang; Park, Keunchil; Kim, Hoon-Kyo; Jang, Joung Soon; Kim, Bong-Seog; Kang, Jin-Hyoung; Lee, Kyung Flee; Kim, Sang-We; Ryoo, Hun Mo; Kim, Jin-Soo; Lee, Ki Hyeong; Kwon, Jung Hye; Choi, Jin-Hyuk; Shin, Sang Won; Hahn, Seokyung; Heo, Dae Seog
- Issue Date
- Cancer Research and Treatment, Vol.51 No.1, pp.119-127
- 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/m(2) intravenously on days 1 and 8+cisplatin 70 mg/m(2) intravenously on day 1 every 3 weeks, or EP, composed of etoposide 100 mg/m(2) intravenously on days 1, 2, 3+cisplatin 70 mg/m(2) 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 months vs. 10.3 months, p=0.120) and the median progression-free survival (6.5 months vs. 5.8 months, p=0.115). However, there was a significant difference in response rate (62.4% vs. 48.2%, p=0.006). The pre-planned subgroup analyses showed that IP was associated with longer overall survival in male (11.3 months vs. 10.1 months, p=0.036), <65 years old (12.7 months vs. 11.3 months, p=0.024), and Eastern Cooperative Oncology Group performance status 0/1 (12.4 months vs. 10.9 months, p=0.040) 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.