학술논문
Early endpoints of a randomized phase II trial of preoperative chemotherapy with S-1/CDDP with or without trastuzumab followed by surgery for HER2-positive resectable gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301C (Trigger Study).
Document Type
Academic Journal
Author
Tokunaga M; Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-Ku, Tokyo, Japan. tokunaga.srg1@tmd.ac.jp.; Machida N; Department of Gastroenterology, Kanagawa Cancer Center, Kanagawa, Japan.; Mizusawa J; Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.; Ito S; Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.; Yabusaki H; Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.; Hirao M; Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.; Watanabe M; Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.; Imamura H; Department of Surgery, Toyonaka Municipal Hospital, Toyonaka, Japan.; Kinoshita T; Department of Gastric Surgery, National Cancer Center Hospital East, Chiba, Japan.; Yasuda T; Department of Surgery, Kinki University Faculty of Medicine, Osaka, Japan.; Hihara J; Department of Gastrointestinal Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan.; Fukuda H; Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.; Yoshikawa T; Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.; Boku N; Department of Oncology and General Medicine, IMSUT Hospital, Institute of Medical Science, University of Tokyo, Tokyo, Japan.; Terashima M; Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi, Japan.
Source
Publisher: Springer-Verlag Tokyo Country of Publication: Japan NLM ID: 100886238 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1436-3305 (Electronic) Linking ISSN: 14363291 NLM ISO Abbreviation: Gastric Cancer Subsets: MEDLINE
Subject
Language
English
Abstract
Background: This randomized phase II study explored the superiority of trastuzumab plus S-1 plus cisplatin (SP) over SP alone as neoadjuvant chemotherapy (NAC) for HER2-positive resectable gastric cancer with extensive lymph node metastasis.
Methods: Eligible patients with HER2-positive gastric or esophagogastric junction cancer and extensive lymph node metastasis were randomized to receive three or four courses of preoperative chemotherapy with SP (arm A) or SP plus trastuzumab (arm B). Following gastrectomy, adjuvant chemotherapy with S-1 was administered for 1 year in both arms. The primary endpoint was overall survival, and the sample size was 130 patients in total. The trial is registered with the Japan Registry of Clinical Trials, jRCTs031180006.
Results: This report elucidates the early endpoints, including pathological findings and safety. The study was terminated early due to slow patient accruals. In total, 46 patients were allocated to arm A (n = 22) and arm B (n = 24). NAC was completed in 20 patients (91%) in arm A and 23 patients (96%) in arm B, with similar incidences of grade 3-4 hematological and non-hematological adverse events. Objective response rates were 50% in arm A and 84% in arm B (p = 0·065). %R0 resection rates were 91% and 92%, and pathological response rates (≥ grade 1b in Japanese classification) were 23% and 50% (p = 0·072) in resected patients, respectively.
Conclusions: Trastuzumab can be safely added to platinum-containing doublet chemotherapy as NAC, and it has the potential to contribute to higher antitumor activity against locally advanced, HER2-positive gastric or esophagogastric junction cancer with extensive nodal metastasis.
(© 2024. The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.)
Methods: Eligible patients with HER2-positive gastric or esophagogastric junction cancer and extensive lymph node metastasis were randomized to receive three or four courses of preoperative chemotherapy with SP (arm A) or SP plus trastuzumab (arm B). Following gastrectomy, adjuvant chemotherapy with S-1 was administered for 1 year in both arms. The primary endpoint was overall survival, and the sample size was 130 patients in total. The trial is registered with the Japan Registry of Clinical Trials, jRCTs031180006.
Results: This report elucidates the early endpoints, including pathological findings and safety. The study was terminated early due to slow patient accruals. In total, 46 patients were allocated to arm A (n = 22) and arm B (n = 24). NAC was completed in 20 patients (91%) in arm A and 23 patients (96%) in arm B, with similar incidences of grade 3-4 hematological and non-hematological adverse events. Objective response rates were 50% in arm A and 84% in arm B (p = 0·065). %R0 resection rates were 91% and 92%, and pathological response rates (≥ grade 1b in Japanese classification) were 23% and 50% (p = 0·072) in resected patients, respectively.
Conclusions: Trastuzumab can be safely added to platinum-containing doublet chemotherapy as NAC, and it has the potential to contribute to higher antitumor activity against locally advanced, HER2-positive gastric or esophagogastric junction cancer with extensive nodal metastasis.
(© 2024. The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.)