Journal of Clinical Oncology, Vol 16, 1068-1074, Copyright © 1998 by American Society of Clinical Oncology
Phase II study of irinotecan combined with cisplatin in patients with previously untreated small-cell lung cancer. West Japan Lung Cancer Group
S Kudoh, Y Fujiwara, Y Takada, H Yamamoto, A Kinoshita, Y Ariyoshi, K Furuse and M Fukuoka
First Department of Internal Medicine, Osaka City University Medical School, Osaka, Japan. shinzohykudoh@msic.med.osaka-cu.ac.jp
PURPOSE: Irinotecan (CPT-11) is effective against small-cell lung cancer
(SCLC) as monotherapy. Cisplatin is also a key drug against SCLC. We
conducted a phase II study of CPT-11 combined with cisplatin to evaluate
the efficacy and toxicity of this regimen in patients with previously
untreated SCLC. PATIENTS AND METHODS: Seventy-five patients with previously
untreated SCLC were enrolled onto the study. CPT-11 60 mg/m2 was
administered intravenously on days 1, 8, and 15 in combination with
cisplatin 60 mg/m2 on day 1 every 28 days. Four courses of chemotherapy
followed by thoracic irradiation were given to patients with limited
disease (LD) and six courses to patients with extensive disease (ED).
RESULTS: The overall response rate was 84%, with a complete response (CR)
rate of 29%. Forty patients with LD achieved an overall response rate of
83% and a CR rate of 30% and 35 patients with ED achieved an overall
response rate of 86% and a CR rate of 29%. The median response duration was
8.0 months for LD patients and 6.6 months for ED patients. The median
survival was 14.3 months for LD patients and 13.0 months for ED patients.
The major grade 3 or 4 toxicities were neutropenia (77%), leukopenia (45%),
diarrhea (19%), and anemia (39%). Two patients died with concomitant
neutropenia and diarrhea. CONCLUSION: This is a new active regimen for
SCLC, especially ED-SCLC, with acceptable toxicity. A phase III study that
compares CPT- 11/cisplatin with etoposide/cisplatin for ED-SCLC is now
being conducted.
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