Meeting
2020 Gastrointestinal Cancers Symposium
Comparing five-weekly S-1 plus cisplatin with tri-weekly capecitabine plus cisplatin in patients with HER2-negative recurrent gastric cancer after S-1 adjuvant therapy or chemotherapy naïve advanced gastric cancer: A pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.
Authors
Jin Matsuyama
Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan
Jin Matsuyama , Hisato Kawakami , Kazumasa Fujitani , Yusuke Akamaru , Shigeyuki Tamura , Shunji Endo , Yutaka Kimura , Youichi Makari , Takao Tamura , Naotoshi Sugimoto , Daisuke Sakai , Toshimasa Tsujinaka , Masahiro Goto , Yukinori Kurokawa , Toshio Shimokawa , Taroh Satoh
Organizations
Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan, Department of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan, Osaka Prefectural General Medical Center, Osaka-Shi, Japan, Department of Surgery, Ikeda Municipal Hospital, Ikeda, Japan, Yao Municipal Hospital, Yao City, Osaka, Japan, Sakai City Medical Center, Sakai, Japan, Department of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan, Osaka International Cancer Institute, Osaka, Japan, Osaka University Hospital, Osaka, Japan, Kaizuka City Hospital, Osaka, Japan, Department of Cancer Chemotherapy Center, Osaka Medical Collage Hospital, Osaka, Japan, Department of Gastroenterological Surgery, Osaka University, Graduate School of Medicine, Suita City, Osaka, Japan, Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG), Osaka, Japan, Osaka University, Osaka, Japan
Research Funding
No funding received
None
Background: HERBIS-2 trial was a phase II trial where S-1 plus cisplatin (SP) and capecitabine plus cisplatin (XP) were compared in recurrent HER2 negative gastric cancer (GC) patients with recurrence free interval (RFI) by S-1containing adjuvant of ≥ 6 months. We performed pooled analyses of HERBIS-2 and HERBIS-4A trial where SP and XP were compared in chemotherapy-naive HER2 negative gastric cancer (GC) patients as these trials being identical. Methods: Both HERBIS-2 and 4A trials, patients were randomly assigned to receive either SP (S-1 at 40–60 mg twice daily for 21 days plus cisplatin at 60 mg/ m2on day 8, every 5 weeks) or XP (capecitabine 1,000 mg/m2twice daily for 14 days plus cisplatin 80 mg/m2on day 1, every 3 weeks). Results: In HERBIS-2 which was s closed early due to poor accrual, SP (N= 10) tended to confer a better overall survival (OS) compared with XP (N= 9)[18.7 (95%CI, 2.8 – NR) monthsvs.13.4 (95% CI, 5.2 – 31.3) months; hazard ratio (HR), 0.443 (95% CI, 0.156 – 1.258);P= .117]. In pooled analyses with HERBIS-2 and 4A, SP (N= 50) vs. XP (N = 51) showed longer progression free survival (6.4 vs.5.1 months; HR, 0.666; P= .62), OS (14.8 vs. 10.6 months; HR, 0.695;P= .099), time to treatment failure (4.6 vs. 3.6 months; HR, 0.668; P= .045), and higher disease control rate (86.4% vs. 68.1%, P= .149). Subgroup analysis revealed that OS benefit in SP arm compared to XP arm was significantly larger if the patient having PS of 0 [HR, 0.554 (95% CI, 0.309 to 0.959; interaction P= .035], or the tumor arising from upper area of stomach [HR, 0.266 (95% CI, 0.070 to 0.731); interaction P= .013] or harboring differentiated type cancer [HR, 0.433 (95% CI, 0.228 to 0.822); interaction P= .011], respectively. Conclusions: Our data suggest the use of SP in the 1stline setting in HER2 negative advanced or recurrent GC with RFI by S-1 adjuvant of ≥ 6 months. Pooled analyses further suggest SP as the standard 1st line chemotherapy for HER2 negative AGC irrespective of S-1 adjuvant in Japan. Clinical trial information: UMIN000006755/UMIN000006105.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session A: Esophageal and Gastric Cancer and Other GI Cancers
Track
Esophageal and Gastric Cancer,Other GI Cancer
Sub Track
Therapeutics
Clinical Trial Registration Number
UMIN000006755/UMIN000006105
Citation
J Clin Oncol 38, 2020 (suppl 4; abstr 379)
Abstract #
379
Poster Bd #
E12
Abstract Disclosures
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