Keiko Minashi1, Keiji Nihei2, Junki Mizusawa3, Kohei Takizawa4, Tomonori Yano5, Yasumasa Ezoe6, Tomohiro Tsuchida7, Hiroyuki Ono4, Toshiro Iizuka8, Noboru Hanaoka9, Ichiro Oda10, Yoshinori Morita11, Masahiro Tajika12, Junko Fujiwara13, Yoshinobu Yamamoto14, Chikatoshi Katada15, Shinichiro Hori16, Hisashi Doyama17, Tsuneo Oyama18, Hiroko Nebiki19, Kenji Amagai20, Yutaro Kubota21, Ken Nishimura22, Nozomu Kobayashi23, Takuto Suzuki24, Kingo Hirasawa25, Toshihisa Takeuchi26, Haruhiko Fukuda3, Manabu Muto27. 1. Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan. 2. Radiation Oncology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan. 3. Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan. 4. Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan. 5. Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan. 6. Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan. 7. Department of Gastroenterology, Cancer Institute Ariake Hospital, Tokyo, Japan. 8. Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan. 9. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. 10. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 11. Department of Gastroenterology, Kobe University School of Medicine, Hyogo, Japan. 12. Department of Endoscopy, Aichi Cancer Center Hospital, Aichi, Japan. 13. Department of Endoscopy, Komagome Hospital, Tokyo, Japan. 14. Department of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan. 15. Department of Gastroenterology, Kitasato University School of Medicine, Kanagawa, Japan. 16. Department of Gastroenterology, Shikoku Cancer Center, Ehime, Japan. 17. Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan. 18. Department of Endoscopy, Saku Central Hospital Advanced Care Center, Nagano, Japan. 19. Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan. 20. Division of Gastroenterology and Gastrointestinal Oncology, Ibaraki Prefectural Central Hospital and Cancer Center, Ibaraki, Japan. 21. Division of Gastroenterology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan. 22. Department of Gastroenterology, Kanagawa Cancer Center, Kanagawa, Japan. 23. Department of Gastroenterology, Tochigi Cancer Center, Tochigi, Japan. 24. Division of Endoscopy, Chiba Cancer Center, Chiba, Japan. 25. Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan. 26. Second Department of Internal Medicine, Osaka Medical Collage, Osaka, Japan. 27. Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: mmuto@kuhp.kyoto-u.ac.jp.
Abstract
BACKGROUND & AIMS: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). METHODS: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. RESULTS: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%). CONCLUSIONS: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.
BACKGROUND & AIMS: Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). METHODS: We performed a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. RESULTS: Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%-94.7%) and 92.6% in all patients (90% confidence interval, 88.5%-95.2%). CONCLUSIONS: In a prospective study of patients with T1b (SM1-2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553.
Authors: Chan Hyuk Park; Dong-Hoon Yang; Jong Wook Kim; Jie-Hyun Kim; Ji Hyun Kim; Yang Won Min; Si Hyung Lee; Jung Ho Bae; Hyunsoo Chung; Kee Don Choi; Jun Chul Park; Hyuk Lee; Min-Seob Kwak; Bun Kim; Hyun Jung Lee; Hye Seung Lee; Miyoung Choi; Dong-Ah Park; Jong Yeul Lee; Jeong-Sik Byeon; Chan Guk Park; Joo Young Cho; Soo Teik Lee; Hoon Jai Chun Journal: Clin Endosc Date: 2020-03-30
Authors: Chan Hyuk Park; Dong-Hoon Yang; Jong Wook Kim; Jie-Hyun Kim; Ji Hyun Kim; Yang Won Min; Si Hyung Lee; Jung Ho Bae; Hyunsoo Chung; Kee Don Choi; Jun Chul Park; Hyuk Lee; Min-Seob Kwak; Bun Kim; Hyun Jung Lee; Hye Seung Lee; Miyoung Choi; Dong-Ah Park; Jong Yeul Lee; Jeong-Sik Byeon; Chan Guk Park; Joo Young Cho; Soo Teik Lee; Hoon Jai Chun Journal: Intest Res Date: 2020-10-13