Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction: KSCC1601,Gastric Cancer

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Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction: KSCC1601
Gastric Cancer ( IF 7.4 ) Pub Date : 2021-08-11 , DOI: 10.1007/s10120-021-01218-0
Masaaki Iwatsuki ₁ , Hiroyuki Orita ₂ , Kazuma Kobayashi ₃ , Shigekazu Hidaka ₄ , Takaaki Arigami ₅ , Tetsuya Kusumoto ₆ , Hironaga Satake ₇ , Eiji Oki ₈ , Satoshi Tsutsumi ₉ , Kazutoshi Tobimatsu ₁₀ , Mototsugu Shimokawa ₁₁ , Hiroshi Saeki ₁₂ , Akitaka Makiyama ₁₃ , Hideo Baba ₁ , Masaki Mori ₈

Affiliation

Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Department of Surgery, Nakatsu Municipal Hospital, Nakatsu, Japan.
Department of Surgery, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Department of Surgical Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Department of Onco-Biological Surgery, Kagoshima University, Kagoshima, Japan.
Department of Gastroenterological Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan.
Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Department of Surgery, Oita Prefectural Hospital, Oita, Japan.
Division of Gastroenterology, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan.
Department of Biostatistics, Cancer Biostatistics Laboratory, Yamaguchi University Graduate School of Medicine, Clinical Research Institute, Yamaguchi, Japan.
Department of General Surgical Science, Graduate School of Medicine, Gunma University, Maebashi, Japan.
Cancer Center, Gifu University Hospital, Gifu, Japan.

Background

Perioperative chemotherapy is the standard of care for locally advanced gastric cancer (LAGC). This phase II study investigated the efficacy and safety of S-1 and oxaliplatin (SOX) as neoadjuvant chemotherapy (NAC) for LAGC and esophagogastric junction cancer (EGJC).

Methods

Patients completed up to three cycles of SOX₁₃₀ (oxaliplatin 130 mg/m² on day 1, oral S-1 40–60 mg twice daily for 2 weeks every 3 weeks), followed by gastrectomy and D2 lymphadenectomy. The primary endpoint was the pathological response rate (pRR). The anastomosis leakage rate was the secondary endpoint in patients with EGJC, and other secondary endpoints were the R0 resection, overall survival (OS), and relapse-free survival (RFS) rates.

Results

Between April 2016 and July 2017, 47 patients (24 EGJC, 23 LAGC) were enrolled in this study. Forty-two patients (89.4%, 95% confidence interval [CI] = 76.9–96.5) underwent surgery, and R0 resection was achieved in 41 patients. The pRR was 59.5% (90% CI = 45.7–72.3). The major grade 3 or 4 toxicities were appetite loss in six patients (12.8%), thrombocytopenia in five patients (10.6%), and neutropenia and diarrhea in three patients (6.4%) each. The rate of severe anastomotic leakage (Clavien–Dindo classification grade III or higher) in 20 EGJC was 25.0% (90% CI = 10.4–45.6). The 3-year OS and RFS rate were 62.9% (95% CI = 47.2–75.1) and 53.2% (95% CI = 38.1–66.2), respectively.

Conclusion

SOX₁₃₀ demonstrated substantial benefit for LAGC and EGJC. However, special attention should be paid to anastomotic leakage during surgery for EGJC.

中文翻译：

S-1和奥沙利铂作为胃或食管胃交界处局部晚期腺癌新辅助化疗的II期研究：KSCC1601

背景

围手术期化疗是局部晚期胃癌（LAGC）的标准治疗。这项 II 期研究调查了 S-1 和奥沙利铂 (SOX) 作为 LAGC 和食管胃结合部癌 (EGJC) 的新辅助化疗 (NAC) 的疗效和安全性。

方法

患者完成了多达三个周期的 SOX ₁₃₀（奥沙利铂 130 mg/m ²第 1 天，口服 S-1 40-60 mg 每天两次，每 3 周连续 2 周），然后进行胃切除术和 D2 淋巴结切除术。主要终点是病理反应率（pRR）。吻合口漏率是 EGJC 患者的次要终点，其他次要终点是 R0 切除率、总生存期 (OS) 和无复发生存期 (RFS) 率。

结果

2016 年 4 月至 2017 年 7 月期间，47 名患者（24 名 EGJC，23 名 LAGC）参加了这项研究。42 名患者（89.4%，95% 置信区间 [CI] = 76.9-96.5）接受了手术，41 名患者实现了 R0 切除。pRR 为 59.5% (90% CI = 45.7–72.3)。主要的 3 级或 4 级毒性是 6 名患者 (12.8%) 的食欲减退、5 名患者 (10.6%) 的血小板减少症和 3 名患者 (6.4%) 的中性粒细胞减少症和腹泻。20 例 EGJC 中严重吻合口漏（Clavien-Dindo 分级 III 级或更高）的发生率为 25.0%（90% CI = 10.4-45.6）。3 年 OS 和 RFS 率分别为 62.9% (95% CI = 47.2–75.1) 和 53.2% (95% CI = 38.1–66.2)。