Journal of Clinical Oncology, Vol 20, Issue 14
(July), 2002: 3054-3060
© 2002 American Society for Clinical Oncology
Phase III Study of Concurrent Versus Sequential Thoracic Radiotherapy in Combination With Cisplatin and Etoposide for Limited-Stage Small-Cell Lung Cancer: Results of the Japan Clinical Oncology Group Study 9104
By Minoru Takada,
Masahiro Fukuoka,
Masaaki Kawahara,
Takahiko Sugiura,
Akira Yokoyama,
Soichiro Yokota,
Yutaka Nishiwaki,
Koshiro Watanabe,
Kazumasa Noda,
Tomohide Tamura,
Haruhiko Fukuda,
Nagahiro Saijo for the Members of the Japan Clinical Oncology Group
From the Osaka Prefectural Habikino Hospital, Osaka City General Medical Center, Kinki National Hospital for Chest Disease, and National Toneyama Hospital for Chest Disease, Osaka; Aichi Cancer Center, Aichi; Niigata Cancer Center Hospital, Niigata; National Cancer Center Hospital East, Chiba; Yokohama Municipal Citizen’s Hospital and Kanagawa Cancer Center, Kanagawa; and National Cancer Center Hospital and National Cancer Center Research Institute, Tokyo, Japan.
Address reprint requests to Nagahiro Saijo, MD, Division of Internal Medicine, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan; email: nsaijo{at}ncc.go.jp
PURPOSE: To evaluate the optimal timing for thoracic radiotherapy (TRT) in limited-stage small-cell lung cancer (LS-SCLC), the Lung Cancer Study Group of the Japan Clinical Oncology Group conducted a phase III study in which patients were randomized to sequential TRT or concurrent TRT.
PATIENTS AND METHODS: We treated 231 patients with LS-SCLC. TRT consisted of 45 Gy over 3 weeks (1.5 Gy twice daily), and the patients were randomly assigned to receive either sequential or concurrent TRT. All patients received four cycles of cisplatin plus etoposide every 3 weeks (sequential arm) or 4 weeks (concurrent arm). TRT was begun on day 2 of the first cycle of chemotherapy in the concurrent arm and after the fourth cycle in the sequential arm.
RESULTS: Concurrent radiotherapy yielded better survival than sequential radiotherapy (P = .097 by log-rank test). The median survival time was 19.7 months in the sequential arm versus 27.2 months in the concurrent arm. The 2-, 3-, and 5-year survival rates for patients who received sequential radiotherapy were 35.1%, 20.2%, and 18.3%, respectively, as opposed to 54.4%, 29.8% and 23.7%, respectively, for the patients who received concurrent radiotherapy. Hematologic toxicity was more severe in the concurrent arm. However, severe esophagitis was infrequent in both arms, occurring in 9% of the patients in the concurrent arm and 4% in the sequential arm.
CONCLUSION: This study strongly suggests that cisplatin plus etoposide and concurrent radiotherapy is more effective for the treatment of LS-SCLC than cisplatin plus etoposide and sequential radiotherapy.
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