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Phase II Study of Etoposide and Cisplatin With Concurrent Twice-Daily Thoracic Radiotherapy Followed by Irinotecan and Cisplatin in Patients With Limited-Disease Small-Cell Lung Cancer: West Japan Thoracic Oncology Group 9902

Hiroshi Saito, Yoshiki Takada, Yukito Ichinose, Kenji Eguchi, Shinzoh Kudoh, Kaoru Matsui, Kazuhiko Nakagawa, Minoru Takada, Shunichi Negoro, Kenji Tamura, Masahiko Ando, Takuhito Tada, Masahiro Fukuoka

From the Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki, Aichi; Departments of Thoracic Oncology and Respiratory Medicine, Hyogo Medical Center for Adults, Akashi, Hyogo; Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka; Department of Internal Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime; Department of Respiratory Medicine, Osaka City University Hospital; Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino; Department of Medical Oncology, Kinki University School of Medicine, Osakasayama; Department of Pulmonary Medicine, Rinku General Medical Center, Izumisano; Department of Radiology, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Osaka; Department of Medical Oncology, Kinki University School of Medicine, Nara Hospital, Ikoma, Nara; and the Health Service, Kyoto University, Kyoto, Japan

Address reprint requests to Hiroshi Saito, MD, Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, 18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan; e-mail: hsaito{at}sun-inet.or.jp

Purpose: We initially conducted a randomized phase II study to compare irinotecan and cisplatin (IP) versus irinotecan, cisplatin, and etoposide (IPE) after etoposide and cisplatin (EP) with concurrent twice-daily thoracic radiotherapy (TRT) in limited-disease small-cell lung cancer (LD-SCLC). We amended the protocol to evaluate IP after EP with concurrent twice-daily TRT in a single-arm phase II study because of an unacceptable toxicity in IPE.

Patients and Methods: Previously untreated patients with LD-SCLC were treated intravenously with etoposide 100 mg/m² on days 1 through 3 and cisplatin 80 mg/m² on day 1 with concurrent twice-daily TRT (1.5 Gy per fraction, a total dose of 45 Gy) beginning on day 2 followed by three cycles of irinotecan 60 mg/m² on days 1, 8, and 15 and cisplatin 60 mg/m² on day 1 of a 4-week cycle.

Results: Of the 51 patients enrolled, 49 patients were assessable for response and toxicity. The overall response rate and complete response rate were 88% and 41%, respectively. The median survival time for all patients was 23 months. The 2-year and 3-year survival rates were 49% and 29.7%, respectively. The median progression-free survival was 11.8 months. The major toxicities observed were neutropenia (grade 4, 84%), febrile neutropenia (grade 3, 31%), infection (grade 3 to 4, 33%), electrolytes imbalance (grade 3 to 4, 20%), and diarrhea (grade 3 to 4, 14%).

Conclusion: EP with concurrent twice-daily TRT followed by the consolidation of IP appears to be an active regimen which deserves further phase III testing in patients with LD-SCLC.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL, and the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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