Yang Zhong-Yin, Yuan Fei, Lu Sheng, Xu Wei, Wu Jun-Wei, Xi Wen-Qi, Shi Min, Wang Zhen-Qiang, Ni Zhen-Tian, He Chang-Yu, Yao Xue-Xin, Zheng Ya-Nan, Zhu Zheng-Lun, Liu Wen-Tao, Zhang Jun, Zhang Huan, Li Chen, Yan Chao, Yan Min, Zhu Zheng-Gang
Department of General Surgery, Gastrointestinal Surgery, Shanghai Key laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Pathology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Front Oncol. 2022 Jun 20;12:905922. doi: 10.3389/fonc.2022.905922. eCollection 2022.
Neoadjuvant intraperitoneal and systemic chemotherapy (NIPS) has shown promising results in gastric cancer (GC) with peritoneal metastasis. However, clinical practice experience of NIPS is still lacking in China. In this study, we investigate the efficacy and safety of NIPS in Chinese patients.
Eligible patients received NIPS every 3 weeks. Gastrectomy was performed for patients who met the criteria of conversion surgery. The primary end point was 1-year overall survival (OS) rate. Secondary end points were the response rate, toxic effects, conversion surgery outcomes and median survival time (MST).
Sixty-seven patients were enrolled. The primary endpoint was achieved with 1-year OS rate reached 67.2% (95% CI, 56.8%-79.4%). Conversion surgery was performed in 42 patients (62.9%), and R0 resection was achieved in 23 patients (54.8%) with the MST of 31.3 months (95% CI, 24.3-38.3). And the MST was 19.3 months (95% CI, 16.4-22.2) for all patients. Toxicity and surgical complications were well-tolerated. Moreover, sex, R0 resection, pathological nodal stage and tumor regression grade (TRG) were independent prognostic factors for patients who underwent conversion surgery.
The NIPS is effective and safe in treating GC patients with peritoneal metastasis. Male patients, patients who underwent R0 resection, patients with ypN0-1 or TRG 1 after conversion surgery are more likely to benefit from the NIPS.
http://www.chictr.org.cn/, identifier https://clinicaltrials.gov/ (
新辅助腹腔内和全身化疗（NIPS）在伴有腹膜转移的胃癌（GC）治疗中已显示出有前景的结果。然而，中国仍缺乏NIPS的临床实践经验。在本研究中，我们调查了NIPS在中国患者中的疗效和安全性。
符合条件的患者每3周接受一次NIPS。对符合转化手术标准的患者进行胃切除术。主要终点是1年总生存率（OS）。次要终点是缓解率、毒性作用、转化手术结果和中位生存时间（MST）。
共纳入67例患者。达到主要终点，1年OS率达到67.2%（95%CI，56.8%-79.4%）。42例患者（62.9%）进行了转化手术，23例患者（54.8%）实现了R0切除，MST为31.3个月（95%CI，24.3-38.3）。所有患者的MST为19.3个月（95%CI，16.4-22.2）。毒性和手术并发症耐受性良好。此外，性别、R0切除、病理淋巴结分期和肿瘤退缩分级（TRG）是接受转化手术患者的独立预后因素。
NIPS治疗伴有腹膜转移的GC患者有效且安全。男性患者、接受R0切除的患者、转化手术后ypN0-1或TRG为1的患者更有可能从NIPS中获益。
