Background Irinotecan hydrochloride, a topoisomerase I inhibitor,is effective against small-cell lung cancer. In a phase 2 studyof irinotecan plus cisplatin in patients with extensive small-celllung cancer, there was a high response rate and a promisingmedian survival time.
Methods We conducted a multicenter, randomized, phase 3 studyin which we compared irinotecan plus cisplatin with etoposideplus cisplatin in patients with extensive (metastatic) small-celllung cancer.
Results The planned size of the study population was 230 patients,but enrollment was terminated early because an interim analysisfound a statistically significant difference in survival betweenthe patients assigned to receive irinotecan and cisplatin andthose assigned to receive etoposide and cisplatin; as a result,only 154 patients were enrolled. The median survival was 12.8months in the irinotecan-plus-cisplatin group and 9.4 monthsin the etoposide-plus-cisplatin group (P=0.002 by the unadjustedlog-rank test). At two years, the proportion of patients survivingwas 19.5 percent in the irinotecan-plus-cisplatin group and5.2 percent in the etoposide-plus-cisplatin group. Severe orlife-threatening myelosuppression was more frequent in the etoposide-plus-cisplatingroup than in the irinotecan-plus-cisplatin group, and severeor life-threatening diarrhea was more frequent in the irinotecan-plus-cisplatingroup than in the etoposide-plus-cisplatin group.
Conclusions Irinotecan plus cisplatin is an effective treatmentfor metastatic small-cell lung cancer.
Source Information
From Kanagawa Cancer Center, Yokohama (K.N.); National Cancer Center Hospital East, Chiba (Y.N.); National Kinki Central Hospital for Chest Diseases, Osaka (M.K.); Osaka City General Hospital, Osaka (S.N.); Aichi Cancer Center, Nagoya (T.S.); Niigata Cancer Center Hospital, Niigata (A.Y.); Kinki University School of Medicine, Osaka (M.F.); Tochigi Cancer Center, Tochigi (K.M.); Yokohama Municipal Citizen's Hospital, Yokohama (K.W.); National Cancer Center Central Hospital, Tokyo (T.T., N.S.); and the Cancer Information and Epidemiology Division, National Cancer Center Research Institute, Tokyo (S.Y.) — all in Japan.
Address reprint requests to Dr. Saijo at the National Cancer Center, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan, or at nsaijo{at}ncc.go.jp.
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