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

  • Minoru Takada
    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.
  • Masahiro Fukuoka
    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.
  • Masaaki Kawahara
    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.
  • Takahiko Sugiura
    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.
  • Akira Yokoyama
    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.
  • Soichiro Yokota
    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.
  • Yutaka Nishiwaki
    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.
  • Koshiro Watanabe
    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.
  • Kazumasa Noda
    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.
  • Tomohide Tamura
    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.
  • Haruhiko Fukuda
    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.
  • Nagahiro Saijo
    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.

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<jats:p> 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. </jats:p><jats:p> 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. </jats:p><jats:p> 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. </jats:p><jats:p> 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. </jats:p>

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