Final results of a phase III trial to evaluate bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).

Authors

null

Hitoshi Katai

National Cancer Center Hospital, Tokyo, Japan

Hitoshi Katai , Yuichiro Doki , Yukinori Kurokawa , Junki Mizusawa , Takaki Yoshikawa , Yutaka Kimura , Shuji Takiguchi , Yasunori Nishida , Takeshi Sano , Kenichi Nakamura , Mitsuru Sasako , Masanori Terashima

Organizations

National Cancer Center Hospital, Tokyo, Japan, Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Suita City, Osaka, Japan, Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan, Kanagawa Cancer Center, Kanagawa, Japan, Sakai City Medical Center, Sakai, Japan, Osaka University Graduate School of Medicine, Osaka, Japan, Keiyukai Sapporo Hospital, Sapporo, Japan, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan, Division of Upper Gastrointestinal Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan, Shizuoka Cancer Center, Shizuoka, Japan

Research Funding

Other Government Agency
Japan Agency for Medical Research and Development

Background: We previously reported that the superiority of bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the expected events observed. We report the final 5-year follow-up data. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach, cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-bursectomy arm or bursectomy arm. Primary endpoint was overall survival (OS), and secondary endpoint was relapse-free survival (RFS). A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: A total of 1204 eligible patients with cT3 / cT4a gastric cancer were randomized (602 in non-bursectomy arm, 602 in bursectomy arm, respectively). Patients’ background and operative procedures were well balanced between the arms. The 5y-OS were 76.5% (95% CI, 72.8 to 79.7) in non-bursectomy arm and 74.9% (71.2 to 78.2) in bursectomy arm. Hazard ratio (HR) for bursectomy was 1.03 (0.83-1.27, one-sided p = 0.598). The 5y-RFS were 70.7% (66.9 to 74.2) in non-bursectomy arm and 66.8% (62.9 to 70.5) in bursectomy arm [HR: 1.131 (0.93-1.38)]. HR for death was almost similar in all sub-categories (0.73-1.29) except cN2 (13th edition of Japanese Classification of Gastric Carcinoma); HR classified by cN was 1.06 (95% CI: 0.75-1.49) for cN0 (n = 521), 1.25 (0.92-1.71) for cN1 (n = 525), and 0.59 (0.32-1.06) for cN2 (n = 158) (p = 0.048 for interaction). The most frequent site of recurrence was the peritoneum [74 (12.3%) in non-bursectomy arm, 73 (12.1%) in bursectomy arm], and bursectomy arm showed a trend of increasing liver metastasis (n = 45, 7.5%) as compared with non-bursectomy arm (n = 33, 5.5%). Six independent poor prognostic factors were identified by multivariable analysis for OS: age ≥ 66 (vs. ≤ 65) (HR, 1.30; 95% CI, 1.04-1.62), macroscopic type 3/5 (vs. type 0/1/2) (1.43; 1.15-1.79), total gastrectomy (vs. distal gastrectomy) (1.44; 1.03-2.02), pT3 (vs. pT1-2) (1.77; 1.17-2.676), pT4 (vs. pT1-2) (3.00; 1.99-4.53), pN1 (vs. pN0) (2.34; 1.52-3.59), pN2-3b (vs. pN0)(4.02; 2.82-5.74) and adjuvant chemotherapy (vs. without chemotherapy) (0.53; 0.42-0.67), but bursectomy was not significant (1.10 0.89-1.36). Conclusions: In the final analysis as well as in the interim analysis, bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.

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Abstract Details

Meeting

2021 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Esophageal and Gastric Cancer

Track

Esophageal and Gastric Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

UMIN000003688

Citation

J Clin Oncol 39, 2021 (suppl 3; abstr 206)

DOI

10.1200/JCO.2021.39.3_suppl.206

Abstract #

206

Poster Bd #

Online Only

Abstract Disclosures