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Gastric Cancer. 2019 Mar 2. doi: 10.1007/s10120-019-00941-z. [Epub ahead of print]

Randomized phase III trial of gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer, the short-term safety and surgical results: Japan Clinical Oncology Group Study (JCOG0501).

Author information

1
Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Monagakubo, Nagaizumi-cho, Sunto-gun, Nagaizumi, Shizuoka, 411-8777, Japan. m.terashima@scchr.jp.
2
Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
3
JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
4
Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.
5
Department of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.
6
Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
7
Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan.
8
Department of Surgery, Sakai City Hospital, Sakai, Japan.
9
Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
10
Department of Surgery, Gifu Municipal Hospital, Gifu, Japan.
11
Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
12
Department of Surgery, Shizuoka General Hospital, Shizuoka, Japan.
13
Department of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan.
14
Department of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
15
Department of Surgery, Hyogo College of Medicine, Kobe, Japan.

Abstract

BACKGROUND:

The prognosis of patients with linitis plastica (type 4) and large (≥ 8 cm) ulcero-invasive-type (type 3) gastric cancer is extremely poor, even after extended surgery and adjuvant chemotherapy. Given the promising results of our previous phase II study evaluating neoadjuvant chemotherapy (NAC) with S-1 plus cisplatin (JCOG0210), we performed a phase III study to confirm the efficacy of NAC in these patients, with the safety and surgical results are presented here.

METHODS:

Eligible patients were randomized to gastrectomy plus adjuvant chemotherapy with S-1 (Arm A) or NAC followed by gastrectomy + adjuvant chemotherapy (Arm B). The primary endpoint was the overall survival (OS). This trial is registered at the UMIN Clinical Trials Registry as C000000279.

RESULTS:

From February 2007 to July 2013, 300 patients were randomized (Arm A 149, Arm B 151). NAC was completed in 133 patients (88%). Major grade 3/4 adverse events during NAC were neutropenia (29.3%), nausea (5.4%), diarrhea (4.8%), and fatigue (2.7%). Gastrectomy was performed in 147 patients (99%) in Arm A and 139 patients (92%) in Arm B. The operation time was significantly shorter in Arm B than in Arm A (median 255 vs. 240 min, respectively; p = 0.024). There were no significant differences in Grade 2-4 morbidity and mortality (25.2% and 1.3% in Arm A and 15.8% and 0.7% in Arm B, respectively).

CONCLUSIONS:

NAC for type 4 and large type 3 gastric cancer followed by D2 gastrectomy can be safely performed without increasing the morbidity or mortality.

KEYWORDS:

Large type 3; Linitis plastica; Neoadjuvant chemotherapy

PMID:
30827001
DOI:
10.1007/s10120-019-00941-z

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