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02.03.2019 | Original Article | Ausgabe 5/2019

Gastric Cancer 5/2019

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)

Zeitschrift:
Gastric Cancer > Ausgabe 5/2019
Autoren:
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, Stomach Cancer Study Group, Japan Clinical Oncology Group
Wichtige Hinweise
The Stomach Cancer Study Group, Japan Clinical Oncology Group members are listed in acknowledgement.

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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.

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