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.

Autor: Iwasaki Y; Department of Surgery, IMS Tokyo Katsushika General Hospital, Tokyo, Japan., Terashima M; Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Shuzioka, 411-8777, Japan. m.terashima@scchr.jp., Mizusawa J; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan., Katayama H; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan., Nakamura K; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan., Katai H; Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan., Yoshikawa T; Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan., Ito S; Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan., Kaji M; Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan., Kimura Y; Department of Surgery, Sakai City Medical Center, Sakai, Japan., Hirao M; Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan., Yamada M; Department of Surgery, Gifu Municipal Hospital, Gifu, Japan., Kurita A; Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan., Takagi M; Department of Surgery, Shizuoka General Hospital, Shizuoka, Japan., Lee SW; Department of General and Gastroenterological Surgery, Osaka Medical College Hospital, Takatsuki, Japan., Takagane A; Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan., Yabusaki H; Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan., Hihara J; Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan., Boku N; Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan., Sano T; Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan., Sasako M; Department of Surgery, Yodogawa Christian Hospital, Osaka, Japan.
Jazyk: angličtina
Zdroj: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2021 Mar; Vol. 24 (2), pp. 492-502. Date of Electronic Publication: 2020 Nov 16.
DOI: 10.1007/s10120-020-01136-7
Abstrakt: 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.
Databáze: MEDLINE
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