Shinji Atagi1, Junki Mizusawa2, Satoshi Ishikura3, Toshiaki Takahashi4, Hiroaki Okamoto5, Hiroshi Tanaka6, Koichi Goto7, Kazuhiko Nakagawa8, Masao Harada9, Yuichiro Takeda10, Naoyuki Nogami11, Yuka Fujita12, Takashi Kasai13, Kazuma Kishi14, Toshiyuki Sawa15, Koji Takeda16, Keisuke Tomii17, Miyako Satouchi18, Takashi Seto19, Yuichiro Ohe20. 1. Department of Thoracic Oncology, Kinki-chuo Chest Medical Center, Osaka, Japan. Electronic address: s-atagi@kch.hosp.go.jp. 2. Japan Clinical Oncology Group Data Center, National Cancer Center Hospital, Tokyo, Japan. 3. Department of Radiology, Nagoya City University, Nagoya, Japan. 4. Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. 5. Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan. 6. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. 7. Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 8. Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan. 9. Department of Respiratory Medicine, Hokkaido Cancer Center, Hokkaido, Japan. 10. Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan. 11. Department of Thoracic Oncology, Shikoku Cancer Center, Ehime, Japan. 12. Department of Respiratory Medicine, Asahikawa Medical Center, Hokkaido, Japan. 13. Department of Medical Oncology, Tochigi Cancer Center, Tochigi, Japan. 14. Department of Respiratory Medicine, Toranomon Hospital, Tokyo, Japan. 15. Division of Respiratory Medicine and Medical Oncology, Gifu Municipal Hospital, Gifu, Japan. 16. Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan. 17. Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan. 18. Department of Thoracic Oncology, Hyogo Cancer Center, Hyogo, Japan. 19. Department of Thoracic Oncology, Kyusyu Cancer Center, Fukuoka, Japan. 20. Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Abstract
INTRODUCTION: In the phase III JCOG0301 trial, chemoradiotherapy (CRT) with daily low-dose carboplatin showed significant benefits in elderly patients with locally advanced non-small-cell lung cancer (NSCLC) compared with radiotherapy (RT) alone. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT in elderly patients are not well elucidated. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years. PATIENTS AND METHODS: Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT or CRT. Prognosis and adverse events data were collected beyond those in the initial report. Late toxicities were defined as occurring more than 90 days after RT initiation. RESULTS:From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better overall survival than the RT arm (hazard ratio, 0.743; 95% confidence interval, 0.552-0.998; 1-sided P = .0239). The proportion of Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) and treatment-related death have been seen since the initial report that was published. CONCLUSION: Long-term follow-up confirmed the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT compared with RT alone.
RCT Entities:
INTRODUCTION: In the phase III JCOG0301 trial, chemoradiotherapy (CRT) with daily low-dose carboplatin showed significant benefits in elderly patients with locally advanced non-small-cell lung cancer (NSCLC) compared with radiotherapy (RT) alone. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT in elderly patients are not well elucidated. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years. PATIENTS AND METHODS: Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT or CRT. Prognosis and adverse events data were collected beyond those in the initial report. Late toxicities were defined as occurring more than 90 days after RT initiation. RESULTS: From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better overall survival than the RT arm (hazard ratio, 0.743; 95% confidence interval, 0.552-0.998; 1-sided P = .0239). The proportion of Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) and treatment-related death have been seen since the initial report that was published. CONCLUSION: Long-term follow-up confirmed the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT compared with RT alone.