Final analysis of single-arm confirmatory study of diagnostic endoscopic resection(ER) plus selective chemoradiotherapy (CRT) for stage I esophageal squamous cell carcinoma (ESCC): JCOG0508.

Authors

null

Keiko Minashi

Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan

Keiko Minashi , Keiji Nihei , Gakuto Ogawa , Kohei Takizawa , Tomonori Yano , Yusuke Amanuma , Tomohiro Tsuchida , Hiroyuki Ono , Toshiro Iizuka , Satoki Shichijyo , Ichiro Oda , Yoshinori Morita , Masahiro Tajika , Junko Fujiwara , Yoshinobu Yamamoto , Chikatoshi Katada , Shinichiro Hori , Hisashi Doyama , Haruhiko Fukuda , Manabu Muto

Organizations

Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan, Tokyo Komagome Hospital, Bunkyo-Ku Tokyo, Japan, Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan, Department of Endoscopy, Shizuoka Cancer Center, Sunto, Japan, Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan, Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, JP, Cancer Institute Hospital, Tokyo, Japan, Division of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan, Toranomon Hospital, Tokyo, Japan, Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan, National Cancer Center Hospital, Tokyo, Japan, Kobe University School of Medicine, Hyogo, Japan, Aichi Cancer Center Hospital, Nagoya, Japan, Tokyo Metropolitan Cancer and Infectious deseases Center Komagome Hospital, Tokyo, Japan, Hyogo Cancer Center, Hyogo, Japan, Kitasato University, Kanagawa, Japan, Depatrment of Endoscopy, Shikoku Cancer Center, Mtatsuyama, Japan, Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan, Kyoto University, Kyoto, Japan

Research Funding

Other Foundation

Background: For clinical stage I submucosal (cT1b-SM) ESCC, surgery is the standard treatment and CRT is optional. We conducted a single-arm confirmatory study of diagnostic ER plus selective CRT for cT1bN0M0 ESCC and reported the 3-year survival at 2016 ASCO Annual Meeting. We will report the final data of survival analysis after 5-year follow-up with a cutoff date of Aug 2017. Methods: Clinical stage I ESCC (cSM1-2, N0M0), tumor size ≤ 5 cm and circumference ≤ 3/4 was eligible. After ER, additional treatment was selected based on the histological evaluation: Group A, pT1a with negative resection margin and no lymphovascular invasion (LVI) -no additional treatment; Group B, pT1b with negative resection margin and pT1a with LVI -prophylactic CRT; Group C, pT1b with positive resection margin -definitive CRT. CRT consisted of concurrent 2 courses of chemotherapy (5-fluorouracil and cisplatin with 4-week interval, and radiotherapy of 41.4 Gy/23 fr (Group B) or 50.4Gy/28 fr (Group C). Primary endpoint was 3-year overall survival (OS) of Group B. The sample size was 82 for primary analysis, with one-sided alpha of 0.05 and power of 90%, based on the expected and threshold 3-year OS as 90% and 80%. Final analysis was planned after 5-year follow-up for all pts. Results: Between Dec 2006 and July 2012, 177 pts were enrolled from 23 institutions in Japan. 176 pts underwent ER and Group A/B/C were 74/87/15, respectively. The 3- and 5-year OS of Group B was 90.8% (90% CI; 84.1- 94.8) and 89.7% (95% CI; 81.1-94.5). The 3- and 5-year OS of all pts was 92.6% (90% CI; 88.6-95.3) and 90.9% (95% CI; 85.6-94.3). Twenty pts relapsed (Group A; 1 primary, 1 distant LN, Group B; 4 primaries , 8 regional LNs, 2 distant, Group C; 2 regional LNs, 2 distant), 7 pts underwent salvage esophagectomy. Univariable analysis in 83 pts of Group B showed that vascular invasion , one course of chemotherapy, SM2 with LVI had lower progression-free survival. Conclusions: Five-year survival data was comparable to that of surgery or CRT for c stage I ESCC. Vascular invasion, one course of chemotherapy, SM2 with LVI may be a risk factor of recurrence for prophylactic CRT after ER. Clinical trial information: UMIN000000553.

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Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

UMIN000000553

Citation

J Clin Oncol 36, 2018 (suppl; abstr 4023)

DOI

10.1200/JCO.2018.36.15_suppl.4023

Abstract #

4023

Poster Bd #

212

Abstract Disclosures

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