We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
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).
- Authors
Terashima, Masanori; Iwasaki, Yoshiaki; Mizusawa, Junki; Katayama, Hiroshi; Nakamura, Kenichi; Katai, Hitoshi; Yoshikawa, Takaki; Ito, Yuichi; Kaji, Masahide; Kimura, Yutaka; Hirao, Motohiro; Yamada, Makoto; Kurita, Akira; Takagi, Masakazu; Boku, Narikazu; Sano, Takeshi; Sasako, Mitsuru
- 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.
- Subjects
STOMACH cancer; CLINICAL trial registries; CISPLATIN; ADJUVANT treatment of cancer; ONCOLOGY
- Publication
Gastric Cancer, 2019, Vol 22, Issue 5, p1044
- ISSN
1436-3291
- Publication type
Article
- DOI
10.1007/s10120-019-00941-z