Ken Kato1, Yoshinori Ito2, Isao Nozaki3, Hiroyuki Daiko4, Takashi Kojima5, Masahiko Yano6, Masaki Ueno7, Satoru Nakagawa8, Masakazu Takagi9, Shigeru Tsunoda10, Tetsuya Abe11, Tetsu Nakamura12, Morihito Okada13, Yasushi Toh14, Yuichi Shibuya15, Seiichiro Yamamoto16, Hiroshi Katayama16, Kenichi Nakamura16, Yuko Kitagawa17. 1. Department of Esophageal Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: kenkato@ncc.go.jp. 2. Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan. 3. Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. 4. Esophageal Surgery Division, National Cancer Center Hospital, Tokyo, Japan. 5. Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 6. Department of Surgery, Osaka International Cancer Center, Osaka, Japan. 7. Gastroenterological Surgery, Toranomon Hospital, Tokyo, Japan. 8. Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan. 9. Department of Surgery, Shizuoka General Hospital, Shizuoka, Japan. 10. Department of Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan. 11. Department of Gastrointestinal Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. 12. Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan. 13. Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan. 14. Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan. 15. Department of Surgery, Kochi Health Sciences Center, Kochi, Japan. 16. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan. 17. Department of Surgery, Keio University, School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND & AIMS: Surgery is the standard of care for T1bN0M0 esophageal squamous cell carcinoma (ESCC), whereas chemoradiotherapy (CRT) is a treatment option. This trial aimed to investigate the noninferiority of CRT relative to surgery for T1bN0M0 ESCC. METHODS: Clinical T1bN0M0 ESCC patients were eligible for enrollment in this prospective nonrandomized controlled study of surgery versus CRT. The primary endpoint was overall survival, which was determined using inverse probability weighting with propensity scoring. Surgery consisted of an esophagectomy with 2- or 3-field lymph node dissection. CRT consisted of 2 courses of 5-fluorouracil (700 mg/m2) on days 1-4 and cisplatin (70 mg/m2) on day 1 every 4 weeks with concurrent radiation (60 Gy). RESULTS: From December 20, 2006 to February 5, 2013, a total of 368 patients were enrolled in the nonrandomized portion of the study. The patient characteristics in surgery arm and CRT arm, respectively, were as follows: median age, 62 and 65 years; proportion of males, 82.8% and 88.1%; and proportion of performance status 0, 99.5% and 98.1%. Comparisons were made using the nonrandomized groups. The 5-year overall survival rate was 86.5% in the surgery arm and 85.5% in the CRT arm (adjusted hazard ratio, 1.05; 95% confidence interval, 0.67-1.64 [<1.78]). The complete response rate in the CRT arm was 87.3% (95% confidence interval, 81.1-92.1). The 5-year progression-free survival rate was 81.7% in the surgery arm and 71.6% in the CRT arm. Treatment-related deaths occurred in 2 patients in the surgery arm and none in the CRT arm. CONCLUSIONS: CRT is noninferior to surgery and should be considered for the treatment of T1bN0M0 ESCC.
BACKGROUND & AIMS: Surgery is the standard of care for T1bN0M0 esophageal squamous cell carcinoma (ESCC), whereas chemoradiotherapy (CRT) is a treatment option. This trial aimed to investigate the noninferiority of CRT relative to surgery for T1bN0M0 ESCC. METHODS: Clinical T1bN0M0 ESCC patients were eligible for enrollment in this prospective nonrandomized controlled study of surgery versus CRT. The primary endpoint was overall survival, which was determined using inverse probability weighting with propensity scoring. Surgery consisted of an esophagectomy with 2- or 3-field lymph node dissection. CRT consisted of 2 courses of 5-fluorouracil (700 mg/m2) on days 1-4 and cisplatin (70 mg/m2) on day 1 every 4 weeks with concurrent radiation (60 Gy). RESULTS: From December 20, 2006 to February 5, 2013, a total of 368 patients were enrolled in the nonrandomized portion of the study. The patient characteristics in surgery arm and CRT arm, respectively, were as follows: median age, 62 and 65 years; proportion of males, 82.8% and 88.1%; and proportion of performance status 0, 99.5% and 98.1%. Comparisons were made using the nonrandomized groups. The 5-year overall survival rate was 86.5% in the surgery arm and 85.5% in the CRT arm (adjusted hazard ratio, 1.05; 95% confidence interval, 0.67-1.64 [<1.78]). The complete response rate in the CRT arm was 87.3% (95% confidence interval, 81.1-92.1). The 5-year progression-free survival rate was 81.7% in the surgery arm and 71.6% in the CRT arm. Treatment-related deaths occurred in 2 patients in the surgery arm and none in the CRT arm. CONCLUSIONS: CRT is noninferior to surgery and should be considered for the treatment of T1bN0M0 ESCC.