Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine, 3-19-18, Nishishinbashi, Minato-ku, Tokyo, 105-8471, Japan.
Invest New Drugs. 2020 Apr;38(2):533-540. doi: 10.1007/s10637-019-00822-3. Epub 2019 Jul 2.
Background Ramucirumab (RAM) plus solvent-based (sb)-paclitaxel (PTX) is the standard second-line chemotherapy for advanced gastric cancer (AGC). The subset analysis of the ABSOLUTE trial, which confirmed non-inferiority of weekly nanoparticle albumin-bound (nab)-PTX to weekly sb-PTX, suggested that nab-PTX might have better efficacy than sb-PTX in patients with peritoneal metastasis. We retrospectively evaluated the efficacy and safety of RAM plus sb-PTX and nab-PTX in patients with peritoneal metastasis of AGC. Methods AGC patients who received RAM plus sb-PTX or nab-PTX as second-line chemotherapy from June 2015 to February 2019 were included in the study. Overall survival (OS), progression-free survival (PFS), response rate, and safety were assessed. Results A total of 128 patients were included in this study (93 in the RAM plus sb-PTX group and 35 in the RAM plus nab-PTX group). PFS was 4.1 months in the RAM plus sb-PTX group and 4.6 months in the RAM plus nab-PTX group (HR 0.90; 95%CI 0.58-1.41, p = 0.643). OS was 8.9 months in the RAM plus sb-PTX group and 11.4 months in the RAM plus nab-PTX group (HR 0.95; 95%CI 0.56-1.62, p = 0.847). A total of 62 and 31 patients had peritoneal metastasis in the RAM plus sb-PTX and the RAM plus nab-PTX groups, respectively. RAM plus nab-PTX showed a slightly longer survival compared to RAM plus sb-PTX in patients with peritoneal metastasis (PFS 5.8 vs 3.5 months, HR 0.66; 95% CI 0.40-1.10, p = 0.109). Conclusion This study suggests that RAM plus nab-PTX might be a more effective treatment for peritoneal metastasis of AGC.
雷莫芦单抗(RAM)联合溶剂型紫杉醇(PTX)是晚期胃癌(AGC)的标准二线化疗。ABSOLUTE 试验的亚组分析证实,与每周溶剂型紫杉醇相比,每周纳米白蛋白结合紫杉醇具有非劣效性,这表明对于腹膜转移的患者,纳米白蛋白结合紫杉醇可能比溶剂型紫杉醇更有效。我们回顾性评估了 RAM 联合溶剂型紫杉醇和纳米白蛋白结合紫杉醇在腹膜转移的 AGC 患者中的疗效和安全性。
本研究纳入了 2015 年 6 月至 2019 年 2 月期间接受 RAM 联合溶剂型紫杉醇或纳米白蛋白结合紫杉醇二线化疗的 AGC 患者。评估总生存期(OS)、无进展生存期(PFS)、缓解率和安全性。
本研究共纳入 128 例患者(RAM 联合溶剂型紫杉醇组 93 例,RAM 联合纳米白蛋白结合紫杉醇组 35 例)。RAM 联合溶剂型紫杉醇组的 PFS 为 4.1 个月,RAM 联合纳米白蛋白结合紫杉醇组的 PFS 为 4.6 个月(HR 0.90;95%CI 0.58-1.41,p=0.643)。RAM 联合溶剂型紫杉醇组的 OS 为 8.9 个月,RAM 联合纳米白蛋白结合紫杉醇组的 OS 为 11.4 个月(HR 0.95;95%CI 0.56-1.62,p=0.847)。RAM 联合溶剂型紫杉醇组和 RAM 联合纳米白蛋白结合紫杉醇组中分别有 62 例和 31 例患者有腹膜转移。在有腹膜转移的患者中,RAM 联合纳米白蛋白结合紫杉醇组的生存时间略长于 RAM 联合溶剂型紫杉醇组(PFS 5.8 比 3.5 个月,HR 0.66;95%CI 0.40-1.10,p=0.109)。
本研究表明,RAM 联合纳米白蛋白结合紫杉醇可能是治疗 AGC 腹膜转移的更有效方法。