Parallel-group controlled trial of esophagectomy versus chemoradiotherapy in patients with clinical stage I esophageal carcinoma (JCOG0502).

Authors

Ken Kato

Ken Kato

Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

Ken Kato , Hiroyasu Igaki , Yoshinori Ito , Isao Nozaki , Hiroyuki Daiko , Masahiko Yano , Masaki Ueno , Satoru Nakagawa , Masakazu Takagi , Shigeru Tsunoda , Tetsuya Abe , Tetsu Nakamura , Jun Hihara , Yasushi Toh , Yuichi Shibuya , Junki Mizusawa , Hiroshi Katayama , Kenichi Nakamura , Yuko Kitagawa

Organizations

Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan, Esophageal Surgery Division, National Cancer Center Hospital, Tokyo, Japan, Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan, Department of Surgery, Shikoku Cancer Center Hospital, Matsuyama, Japan, National Cancer Center Hospital East, Kashiwa, Japan, Osaka International Cancer Center, Osaka, Japan, Gastroenterological Surgery, Toranomon Hospital, Tokyo, Japan, Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan, Shizuoka General Hospital, Shizuoka, Japan, Department of Surgery, Kyoto University, Kyoto, Japan, Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan, Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan, Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan, Department of Gastroenterological Surgery, National Kyushu Cancer Center, Fukuoka, Japan, Department of Gastroenterological Surgery, Kochi Health Sciences Center, Kochi, Japan, Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan, JCOG Data Center/ Operation Office, National Cancer Center, Tokyo, Japan, Keio University School of Medicine, Tokyo, Japan

Research Funding

Other Foundation

Background: Esophagectomy (E) is the standard of care for stage I esophageal squamous cell carcinoma (ESCC), while chemoradiotherapy (CRT) is a treatment option. A parallel-group controlled trial including randomized arms to confirm the non-inferiority of CRT to E for stage IA ESCC was conducted. Methods: Patients (pts) with thoracic ESCC, adenosquamous cell, or basaloid cell carcinoma with stage IA (T1bN0M0), age 20 to 75, performance status 0 to 1, and adequate organ function were eligible. If pts accepted randomization, they were randomly allocated to E with 2-3 field lymph node dissection (arm A) or CRT (arm B). However, if pts had a preference and refused randomization, they were allocated to pts preference arm, E (arm C) or CRT (arm D). CRT consisted of cisplatin and 5-FU, with radiation at the dose of 60 Gy concurrently. The primary endpoint was overall survival (OS) of arm A and B, secondary endpoint included OS of arm C and D using inverse probability weighting with propensity score. The planned sample size in arm A and B was 114 pts in total with one-sided alpha of 10%, power of 75% and non-inferiority margin of HR as 1.78. The sample size in arm C and D was at least 156 pts in each arm with one-sided alpha of 2.5%, power of 85% and non-inferiority margin of HR as 1.78. Results: Between December 2006 and February 2013, 379 (Arm A: 4, B: 7, C: 209 C, D: 159) pts were enrolled. Primary endpoint was not calculated due to small number of randomized arms. Patients characteristics of arm C and D were as follows; median age: 62 and 65, male (%): 82.8 and 88.1, PS 0 (%): 99.5 and D 98.1. All histologic type was SCC except one basaloid cell carcinoma in arm C. The 3- and 5-year OS were 94.7% and 86.5% in arm C, and 93.1% and 85.5% in arm D (adjusted HR 1.05; 95% CI 0.67-1.64 [< 1.78]).Treatment related death were observed in two pts in arm C and none in arm D. Conclusions: Though the accrual of randomized arms was shortened, CRT showed trend toward non-inferiority compared to E in pts preference arms. CRT is considered as a treatment option for stage IA ESCC with organ preservation. Clinical trial information: UMIN000000551.

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Abstract Details

Meeting

2019 Gastrointestinal Cancers Symposium

Session Type

Rapid Oral Abstract Session

Session Title

Rapid Abstract Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

UMIN000000551

Citation

J Clin Oncol 37, 2019 (suppl 4; abstr 7)

DOI

10.1200/JCO.2019.37.4_suppl.7

Abstract #

7

Abstract Disclosures

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