Phase II study of irinotecan combined with carboplatin in previously untreated non-small-cell lung cancer.
OBJECTIVE
Irinotecan, a topoisomerase I inhibitor, is an effective agent for non-small-cell lung cancer (NSCLC). To determine the efficacy and toxicity of irinotecan and carboplatin, we conducted a phase II study in 61 patients with advanced NSCLC.


METHODS
Every 4 weeks, the patients received irinotecan 50 mg/m2 (days 1, 8 and 15) and carboplatin (day 1) with a target AUC of 5 mg min/ml using the Chatelut formula.


RESULTS
All patients were evaluable for toxicity, and of 59 patients evaluable for response, 20 achieved a partial response and 26 showed no change. The overall response rate was 34% (95% confidence interval 23-48%). Grade 3 or 4 anemia, leukopenia, neutropenia, thrombocytopenia and diarrhea occurred in 32%, 32%, 60%, 25%, and 7%, respectively. The median survival time and 1-year, and 2-year survival rates were 10.0 months, 37.6%, and 15.2%, respectively.


CONCLUSIONS
Irinotecan with carboplatin is effective for advanced NSCLC and safe.
Fukuda
Minoru
M
Division of Respiratory Disease, Department of Medicine, Kawasaki Medical School, 577 Matsushima, Kurashiki, 701-0192, Okayama, Japan, mifukuda258@nifty.com.
Oka
Mikio
M
Soda
Hiroshi
H
Kinoshita
Akitoshi
A
Fukuda
Masaaki
M
Nagashima
Seiji
S
Kuba
Mutsuo
M
Takatani
Hiroshi
H
Tsurutani
Junji
J
Nakamura
Yoichi
Y
Kasai
Takashi
T
Inoue
Yuichi
Y
Soejima
Yoshifumi
Y
Kohno
Shigeru
S
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced
D000077146:Irinotecan; D016190:Carboplatin; D002166:Camptothecin