Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer center, Peking University Cancer Hospital and Institute, Fu-Cheng Road 52#, Hai-Dian District, Beijing, 100142, China.
BMC Cancer. 2021 Mar 2;21(1):216. doi: 10.1186/s12885-021-07925-2.
HIPEC is an emerging procedure to treat peritoneal metastasis of gastric cancer. Data about HIPEC in locally advanced gastric cancer is scarce. The purpose of this trial is to evaluate the safety and toxicity of prophylactic HIPEC with cisplatin for patients with locally advanced gastric cancer.
From March 2015 to November 2016, a prospective, randomized phase II trial was conducted. After radical gastrectomy, patients in the experimental group underwent HIPEC with cisplatin followed by adjuvant chemotherapy with SOX regime. Patients in the other group were treated with SOX regime alone. Postoperative complications and patient survival were compared.
In total, 50 patients were eligible for analyses. No significant difference was found in the incidence of postoperative complications including anastomotic/intestinal leakage, liver dysfunction, bone marrow suppression, wound infection and ileus (P > 0.05). Mean duration of hospitalization after radical gastrectomy was 11.7 days. 12.2 days in experimental group and 10.8 days in control group respectively (P = 0.255). The percentage of patients with elevated tumor markers was 12.1% in experimental group, which was significantly lower than 41.2% in control group (P = 0.02). 3-year RFS of patients who treated with or without prophylactic HIPEC were 84.8 and 88.2% respectively (P = 0.986). In the multivariate analysis, pathological T stage was the only independent risk factor for the RFS of patients (P = 0.012, HR =15.071).
Additional intraoperative HIPEC with cisplatin did not increase postoperative complications for locally advanced gastric cancer after curative surgery. Prophylactic HIPEC with cisplatin was safe and tolerable, while it did not reduce the risk of peritoneal recurrence in this trial, supporting further studies to validate the efficacy of it.
Chinese Clinical Trial Registry, ChiCTR2000038331. Registered 18 September 2020 - Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=59692 .
HIPEC 是一种新兴的治疗胃癌腹膜转移的方法。关于局部进展期胃癌 HIPEC 的数据很少。本试验的目的是评估局部进展期胃癌患者预防性顺铂 HIPEC 的安全性和毒性。
从 2015 年 3 月至 2016 年 11 月，进行了一项前瞻性、随机的二期试验。根治性胃切除术后，实验组患者接受顺铂 HIPEC 联合 SOX 方案辅助化疗，对照组患者仅接受 SOX 方案治疗。比较术后并发症和患者生存情况。
共 50 例患者符合分析条件。两组术后并发症（吻合口/肠漏、肝功能障碍、骨髓抑制、伤口感染和肠梗阻）发生率无显著差异（P>0.05）。根治性胃切除术后平均住院时间分别为实验组 11.7 天和对照组 10.8 天（P=0.255）。实验组肿瘤标志物升高患者比例为 12.1%，明显低于对照组的 41.2%（P=0.02）。接受或不接受预防性 HIPEC 的患者 3 年 RFS 分别为 84.8%和 88.2%（P=0.986）。多因素分析显示，病理 T 分期是患者 RFS 的唯一独立危险因素（P=0.012，HR=15.071）。
根治性手术后，术中额外应用顺铂 HIPEC 不会增加局部进展期胃癌的术后并发症。预防性顺铂 HIPEC 安全且耐受良好，但在本试验中并未降低腹膜复发的风险，支持进一步研究验证其疗效。
中国临床试验注册中心，ChiCTR2000038331。注册日期 2020 年 9 月 18 日-回顾性注册，http://www.chictr.org.cn/showproj.aspx?proj=59692。
