Department of Gastroenterological Surgery, Komaki City Hospital, Komaki, Japan.
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Ann Surg Oncol. 2024 Feb;31(2):735-743. doi: 10.1245/s10434-023-14240-6. Epub 2023 Nov 11.
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/m. 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.
腹腔内化疗对伴有腹膜转移的胃癌具有一定前景。尽管一项 III 期研究未能显示腹腔内紫杉醇联合 S-1 和静脉紫杉醇在统计学上具有显著优势，但敏感性分析提示了其临床疗效。因此，有必要尝试将腹腔内紫杉醇与其他疗效更高的全身治疗方法联合使用。我们旨在探讨腹腔内紫杉醇联合 S-1 和顺铂的疗效。
患有腹膜转移的胃癌患者被纳入这项 II 期试验。除了每 5 周进行的既定 S-1 和顺铂方案外，在第 1、8 和 22 天给予腹腔内紫杉醇，剂量为 20mg/m。主要终点为治疗开始后 1 年的总生存率。次要终点为无进展生存率和毒性。
53 例患者入组并对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%），达到了主要终点。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%）、贫血症（30%）、腹泻（13%）和厌食症（17%）。四名患者出现腹腔内导管和植入式端口相关并发症。有一例与治疗相关的死亡。
腹腔内紫杉醇联合 S-1 和顺铂治疗腹膜转移的胃癌患者耐受性良好且疗效显著。
