PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: http://www.chictr.org.cn/, identifier https://clinicaltrials.gov/ ().
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: http://www.chictr.org.cn/, identifier https://clinicaltrials.gov/ (
摘要：
■新辅助腹膜内和全身化疗（NIPS）在伴有腹膜转移的胃癌（GC）中显示出可喜的结果。然而,我国目前还缺乏NIPS的临床实践经验。在这项研究中,我们调查了NIPS在中国患者中的有效性和安全性。
■符合条件的患者每3周接受一次NIPS。对符合转换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）。次要终点是反应率，毒性作用,转换手术结果和中位生存时间(MST)。
■纳入67例患者。主要终点为1年OS率达到67.2%（95%CI，56.8%-79.4%）。42例患者（62.9%）进行了转换手术，23例患者（54.8%）完成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消退分级(TRG)是中转手术患者的独立预后因素.
■NIPS在治疗有腹膜转移的GC患者中是有效且安全的。男性患者,接受R0切除的患者，转换手术后患有ypN0-1或TRG1的患者更有可能从NIPS中获益.
■http://www.chictr.org.cn/,标识符https://clinicaltrials.gov/()。
■符合条件的患者每3周接受一次NIPS。对符合转换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）。次要终点是反应率，毒性作用,转换手术结果和中位生存时间(MST)。
■纳入67例患者。主要终点为1年OS率达到67.2%（95%CI，56.8%-79.4%）。42例患者（62.9%）进行了转换手术，23例患者（54.8%）完成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消退分级(TRG)是中转手术患者的独立预后因素.
■NIPS在治疗有腹膜转移的GC患者中是有效且安全的。男性患者,接受R0切除的患者，转换手术后患有ypN0-1或TRG1的患者更有可能从NIPS中获益.
■http://www.chictr.org.cn/,标识符https://clinicaltrials.gov/(
