Randomized phase III trial of gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-03-02

AUTHORS

Masanori Terashima, Yoshiaki Iwasaki, Junki Mizusawa, Hiroshi Katayama, Kenichi Nakamura, Hitoshi Katai, Takaki Yoshikawa, Yuichi Ito, Masahide Kaji, Yutaka Kimura, Motohiro Hirao, Makoto Yamada, Akira Kurita, Masakazu Takagi, Narikazu Boku, Takeshi Sano, Mitsuru Sasako,

ABSTRACT

BackgroundThe 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.MethodsEligible 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.ResultsFrom 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).ConclusionsNAC for type 4 and large type 3 gastric cancer followed by D2 gastrectomy can be safely performed without increasing the morbidity or mortality. More... »

PAGES

1044-1052

Journal

TITLE

Gastric Cancer

ISSUE

5

VOLUME

22

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10120-019-00941-z

DOI

http://dx.doi.org/10.1007/s10120-019-00941-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112504584

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30827001


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382 grid-institutes:grid.415535.3 schema:alternateName Department of Surgery, Gifu Municipal Hospital, Gifu, Japan
383 schema:name Department of Surgery, Gifu Municipal Hospital, Gifu, Japan
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385 grid-institutes:grid.415740.3 schema:alternateName Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
386 schema:name Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
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388 grid-institutes:grid.415797.9 schema:alternateName Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Monagakubo, Nagaizumi-cho, Sunto-gun, 411-8777, Nagaizumi, Shizuoka, Japan
389 schema:name Division of Gastric Surgery, Shizuoka Cancer Center, 1007 Monagakubo, Nagaizumi-cho, Sunto-gun, 411-8777, Nagaizumi, Shizuoka, Japan
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392 schema:name Department of Surgery, Shizuoka General Hospital, Shizuoka, Japan
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394 grid-institutes:grid.416803.8 schema:alternateName Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan
395 schema:name Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan
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397 grid-institutes:grid.417235.6 schema:alternateName Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan
398 schema:name Department of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan
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