Second Department of Surgery, Wakayama Medical University, Wakayama, Japan,
Second Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Oncology. 2021;99(1):57-61. doi: 10.1159/000509396. Epub 2020 Sep 2.
A regimen of S-1 combined with oxaliplatin (SOX) has been widely used as the first-line regimen for advanced gastric cancer. To further improve the antitumor efficacy for gastric cancer patients with peritoneal metastasis, we added nab-paclitaxel to the established SOX regimen (NSOX). Nab-paclitaxel (nanoparticle albumin-bound paclitaxel) has effective transferability to tumor tissues and strong antitumor effects for peritoneal metastasis. We performed a phase 1 study of this regimen to determine the maximum tolerated dose (MTD) and the recommended dose (RD) in patients with gastric cancer with peritoneal metastasis.
The NSOX regimen involved 21-day cycles with escalated doses of nab-paclitaxel (50 [level 1] to 80 [level 4] mg/m2 on days 1 and 8) and fixed doses of oxaliplatin (100 mg/m2 on day 1) and S-1 (80 mg/m2/day for 2 weeks).
Six patients with gastric cancer with peritoneal metastasis were enrolled. The MTD was determined to be dose level 2, as 2 of 3 patients experienced dose-limiting toxicities (DLTs), grade 4 non-hematological toxicities. One patient experienced acute myocardial infarction, and the other patient developed jejunal perforation. There were no treatment-related deaths. No patients experienced DLTs, so the RD was determined to be dose level 1.
The NSOX regimen was shown to be a tolerable regimen and may be a promising triplet therapy for patients with gastric cancer with peritoneal metastasis.
替吉奥联合奥沙利铂（SOX）方案已广泛用于晚期胃癌的一线治疗。为了进一步提高腹膜转移的胃癌患者的抗肿瘤疗效，我们在既定的 SOX 方案中加入了白蛋白结合型紫杉醇（nab-紫杉醇）（NSOX）。nab-紫杉醇（纳米白蛋白结合型紫杉醇）具有向肿瘤组织有效转移的能力，对腹膜转移具有强大的抗肿瘤作用。我们进行了这项方案的 1 期研究，以确定腹膜转移的胃癌患者的最大耐受剂量（MTD）和推荐剂量（RD）。
NSOX 方案包括 21 天周期，nab-紫杉醇剂量递增（第 1 天和第 8 天 50[第 1 级]至 80[第 4 级]mg/m2），奥沙利铂和替吉奥剂量固定（第 1 天 100mg/m2，2 周内每天 80mg/m2）。
共纳入 6 例腹膜转移的胃癌患者。MTD 确定为剂量 2 级，因为 3 例中有 2 例发生剂量限制性毒性（DLT），即 4 级非血液学毒性。1 例患者发生急性心肌梗死，另 1 例患者发生空肠穿孔。无治疗相关死亡。无患者发生 DLT，因此 RD 确定为剂量 1 级。
NSOX 方案具有良好的耐受性，可能是腹膜转移的胃癌患者有前途的三联疗法。
