Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open
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ORIGINAL ARTICLE
Gastrectomy with or without neoadjuvant S‑1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open‑label, phase 3, randomized controlled trial Yoshiaki Iwasaki1 · Masanori Terashima2 · Junki Mizusawa3 · Hiroshi Katayama3 · Kenichi Nakamura3 · Hitoshi Katai4 · Takaki Yoshikawa5 · Seiji Ito6 · Masahide Kaji7 · Yutaka Kimura8 · Motohiro Hirao9 · Makoto Yamada10 · Akira Kurita11 · Masakazu Takagi12 · Sang‑Woong Lee13 · Akinori Takagane14 · Hiroshi Yabusaki15 · Jun Hihara16 · Narikazu Boku17 · Takeshi Sano18 · Mitsuru Sasako19 Received: 3 September 2020 / Accepted: 19 October 2020 © The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2020
Abstract Background Specific treatment strategies are sorely needed for scirrhous-type gastric cancer still, which has poor prognosis. Based on the promising results of our previous phase II study (JCOG0210), we initiated a phase III study to confirm the efficacy of neoadjuvant chemotherapy (NAC) in type 4 or large type 3 gastric cancer. Methods Patients aged 20–75 years without a macroscopic unresectable factor as confirmed via staging laparoscopy were randomly assigned to surgery followed by adjuvant chemotherapy with S-1 (Arm A) or NAC (S-1plus cisplatin) followed by D2 gastrectomy plus adjuvant chemotherapy with S-1 (Arm B). The primary endpoint was overall survival (OS). Results Between October 2005 and July 2013, 316 patients were enrolled, allocating 158 patients to each arm. In Arm B, in which NAC was completed in 88% of patients. Significant downstaging based on tumor depth, lymph node metastasis, and peritoneal cytology was observed using NAC. Excluding the initial 16 patients randomized before the first revision of the protocol, 149 and 151 patients in arms A and B, respectively, were included in the primary analysis. The 3-year OS rates were 62.4% [95% confidence interval (CI) 54.1–69.6] in Arm A and 60.9% (95% CI 52.7–68.2) in Arm B. The hazard ratio of Arm B against Arm A was 0.916 (95% CI 0.679–1.236). Conclusions For type 4 or large type 3 gastric cancer, NAC with S-1 plus cisplatin failed to demonstrate a survival benefit. D2 surgery followed by adjuvant chemotherapy remains the standard treatment. Keywords Type 4 · Linitis plastica · Large type 3 · Neoadjuvant chemotherapy
Introduction Gastric cancer (GC) is the third leading cause of cancerrelated death [1]. Although the incidence of GC in Japan has decreased in recent years, similar to that observed in Western countries, it remains the second most common cancer in Japan [2]. Among GCs, Borrmann type 4 GC, including linitis plastica and scirrhous-type cancer, has the Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10120-020-01136-7) contains supplementary material, which is available to authorized users. * Masanori Terashima [email protected] Extended author information available on the last page of the article
unique characteristics of diffuse invasion inside the gastric wal
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