晚期胃癌患者每三周一次低剂量纳米白蛋白结合型紫杉醇化疗的II期研究
A Phase II Study of Tri-weekly Low-dose Nab-paclitaxel Chemotherapy for Patients with Advanced Gastric Cancer.
作者信息
Sato Sho, Kunisaki Chikara, Tanaka Yusaku, Sato Kei, Miyamoto Hiroshi, Yukawa Norio, Fujii Yoshiro, Kimura Jun, Takagawa Ryo, Takahashi Masazumi, Kosaka Takashi, Akiyama Hirotoshi, Saigusa Yusuke, Taguri Masataka, Yamanaka Takeharu, Endo Itaru
机构信息
Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama, Japan.
Department of Surgery, Gastroenterological Center, Yokohama City University, Yokohama, Japan
出版信息
Anticancer Res. 2018 Dec;38(12):6911-6917. doi: 10.21873/anticanres.13068.
BACKGROUND/AIM: Nanoparticle albumin-bound (nab)-paclitaxel has demonstrated antitumor activity against advanced gastric cancer. However, gastric cancer patients can be difficult to treat with the recommended dose because of the high incidence of adverse toxicities. The aim of this study was to evaluate the safety and effectiveness of low-dose nab-paclitaxel in a multicenter, single-arm, phase II study.
PATIENTS AND METHODS
Treatment included low doses of 180 mg/m nab-paclitaxel administered on day 1 of each 21-day cycle. The primary endpoint was defined as the overall response rate (ORR). The secondary endpoints included progression-free survival (PFS), safety, and overall survival (OS). A total of 34 patients were enrolled in the full-analysis set.
RESULTS
The ORR was 5.9%. The median PFS and OS were 2.4 months and 9.2 months, respectively. The most common grade 3/4 toxicities were anemia (8.8%), neutropenia (5.9%), appetite loss (5.9%) and peripheral sensory neuropathy (5.9%). No treatment-related deaths occurred.
CONCLUSION
The tri-weekly low dose of nab-paclitaxel therapy is effective towards advanced gastric cancer patients with good tolerability and an acceptable margin of safety.
背景/目的：纳米白蛋白结合型（nab）紫杉醇已显示出对晚期胃癌的抗肿瘤活性。然而，由于不良反应发生率高，胃癌患者可能难以接受推荐剂量的治疗。本研究的目的是在一项多中心、单臂、II期研究中评估低剂量nab紫杉醇的安全性和有效性。
患者与方法
治疗包括在每21天周期的第1天给予低剂量180mg/m²的nab紫杉醇。主要终点定义为总缓解率（ORR）。次要终点包括无进展生存期（PFS）、安全性和总生存期（OS）。共有34例患者纳入全分析集。
结果
ORR为5.9%。中位PFS和OS分别为2.4个月和9.2个月。最常见的3/4级毒性反应为贫血（8.8%）、中性粒细胞减少（5.9%）、食欲减退（5.9%）和周围感觉神经病变（5.9%）。未发生与治疗相关的死亡。
结论
每三周一次的低剂量nab紫杉醇治疗对晚期胃癌患者有效，耐受性良好，安全性可接受。
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