Phase II study of 3-week scheduling of irinotecan in combination with cisplatin in patients with advanced nonsmall-cell lung cancer.
OBJECTIVE
The combination of irinotecan and cisplatin given every 4 weeks is one of the standard treatments for advanced nonsmall-cell lung cancer (NSCLC) in Japan. The purpose of this study is to evaluate the efficacy, safety and dose-intensity as a measure of the feasibility of 3-week scheduling of irinotecan and cisplatin in patients with advanced NSCLC in phase II study.


METHODS
Previously untreated patients with stage IIIB and IV NSCLC were treated intravenously with irinotecan (60 mg/m2) on days 1 and 8 and cisplatin (60 mg/m2) on day 1 of a 3-week cycle.


RESULTS
Of the 28 patients enrolled, 27 were evaluable for response and toxicity. The response rate was 30% (95% confidence interval, 14-50%). The median duration of response was 16 weeks (range, 10-26 weeks). The median survival time for all patients was 52 weeks and the 1-year and 2-year survival rates were 48% and 29%, respectively. The dose-intensity of irinotecan was 34 mg/m2/wk (range, 19-40). The major toxicities observed were neutropenia (grade 3, 30%; 4, 30%), leukopenia (grade 3, 30%), and diarrhea (grade 3, 22%). Other toxicities were generally mild.


CONCLUSIONS
Three-week scheduling of irinotecan and cisplatin is effective and feasible in advanced NSCLC.
Saito
Hiroshi
H
Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki, Japan. hsaito@sun-inet.or.jp
Kudoh
Shinzoh
S
Nakagawa
Kazuhiko
K
Negoro
Shunichi
S
Matsui
Kaoru
K
Semba
Hiroshi
H
Takada
Minoru
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin