腹腔内化疗对于腹膜转移的胃癌有希望。尽管III期研究未能显示腹腔注射紫杉醇联合S-1和静脉注射紫杉醇具有统计学上的显着优势，但敏感性分析提示了临床疗效。因此，有必要尝试将腹膜内紫杉醇与其他具有更高功效的全身疗法相结合。我们试图探讨腹腔注射紫杉醇联合S-1和顺铂的疗效。II期试验纳入腹膜转移的胃癌患者。除了每 5 周建立的 S-1 和顺铂方案外，还在第 1、8 和 22 天腹腔注射紫杉醇，剂量为 20 mg/m2。主要终点是治疗开始后 1 年的总体生存率。次要终点是无进展生存期和毒性。招募了 53 名患者并对其疗效和毒性进行了全面评估。 1 年总生存率为 73.6%（95% 置信区间 59.5-83.4%），达到主要终点。中位生存时间为 19.4 个月（95% 置信区间，16.1-24.6 个月）。 1 年无进展生存率为 49.6%（95% 置信区间，34.6-62.9%）。 3/4 级血液学和非血液学毒性的发生率分别为 43% 和 47%。常见的 3/4 级毒性包括中性粒细胞减少症 (25%)、贫血 (30%)、腹泻 (13%) 和厌食症 (17%)。 4 名患者观察到腹腔内导管和植入端口相关并发症。发生 1 例治疗相关死亡。腹腔注射紫杉醇联合 S-1 和顺铂对腹膜转移的胃癌患者耐受性良好且有效。© 2023。外科肿瘤学会。

Intraperitoneal chemotherapy is promising for gastric cancer with peritoneal metastasis. Although a phase III study failed to show a statistically significant superiority of intraperitoneal paclitaxel combined with S-1 and intravenous paclitaxel, the sensitivity analysis suggested clinical efficacy. Thus, attempts to combine intraperitoneal paclitaxel with other systemic therapies with higher efficacy have been warranted. We sought to explore the efficacy of intraperitoneal paclitaxel with S-1 and cisplatin.Gastric cancer patients with peritoneal metastasis were enrolled in the phase II trial. In addition to the established S-1 and cisplatin regimen every 5 weeks, intraperitoneal paclitaxel was administered on days 1, 8, and 22 at a dose of 20 mg/m2. The primary endpoint was overall survival rate at 1 year after treatment initiation. Secondary endpoints were progression-free survival and toxicity.Fifty-three patients were enrolled and fully evaluated for efficacy and toxicity. The 1-year overall survival rate was 73.6% (95% confidence interval 59.5-83.4%), and the primary endpoint was met. The median survival time was 19.4 months (95% confidence interval, 16.1-24.6 months). The 1-year progression-free survival rate was 49.6% (95% confidence interval, 34.6-62.9%). The incidences of grade 3/4 hematological and non-hematological toxicities were 43% and 47%, respectively. The frequent grade 3/4 toxicities included neutropenia (25%), anemia (30%), diarrhea (13%), and anorexia (17%). Intraperitoneal catheter and implanted port-related complications were observed in four patients. There was one treatment-related death.Intraperitoneal paclitaxel combined with S-1 and cisplatin is well tolerated and active in gastric cancer patients with peritoneal metastasis.© 2023. Society of Surgical Oncology.