Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer.
Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer.
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DOI：
10.1111/cas.12419
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发表时间：
2014-07
期刊：
影响因子：
5.7
通讯作者：
Miyata Y
中科院分区：
文献类型：
--
作者：
Sasaki Y;Nishina T;Yasui H;Goto M;Muro K;Tsuji A;Koizumi W;Toh Y;Hara T;Miyata Y
这项多中心II期研究首先研究了纳米粒白蛋白结合紫杉醇（nab-paclitaxel）每3周给药一次的疗效和安全性，这些患者患有不可切除或复发的胃癌，之前接受过一轮含氟嘧啶的化疗。研究了不可切除或复发性胃癌患者，尽管接受了含氟嘧啶的治疗，但仍发生进展。在每个21天周期的第1天静脉给予Nab-紫杉醇260 mg/m2，不进行抗过敏前驱用药，直至疾病进展或研究中止。主要终点是总体缓解率。次要终点是疾病控制率、无进展生存期、总生存期和安全性。从2008年4月至2010年7月，入组了56例患者，55例患者接受了研究治疗，54例患者的缓解可评价。根据独立审查委员会，总体缓解率为27.8%（15/54; 95%置信区间[CI]，16.5-41.6），疾病控制率为59.3%（32/54; 95% CI，45.0-72.4）。1例患者完全缓解。中位无进展生存期和总生存期分别为2.9个月（95%CI，2.4-3.6）和9.2个月（95%CI，6.9-11.4）。最常见的3/4级毒性为中性粒细胞减少症（49.1%）、白细胞减少症（20.0%）、淋巴细胞减少症（10.9%）和周围感觉神经病变（23.6%）。无治疗相关死亡。白蛋白结合型紫杉醇，每3周给药一次，对以前治疗过的不可切除或复发的胃癌显示出有希望的活性，具有良好的耐受性毒性。（试用注册，ClinicalTrials.gov：NCT 00661167）。
This multicenter phase II study first investigated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) when given every 3 weeks to patients with unresectable or recurrent gastric cancer who had received a prior round of fluoropyrimidine-containing chemotherapy. Patients with unresectable or recurrent gastric cancer who experienced progression despite fluoropyrimidine-containing treatment were studied. Nab-paclitaxel was given i.v. at 260 mg/m2 on day 1 of each 21-day cycle without anti-allergic premedication until disease progression or study discontinuation. The primary endpoint was the overall response rate. The secondary endpoints were the disease control rate, progression-free survival, overall survival, and safety. From April 2008 to July 2010, 56 patients were enrolled, 55 patients received the study treatment, and 54 patients were evaluable for responses. According to an independent review committee, the overall response rate was 27.8% (15/54; 95% confidence interval [CI], 16.5–41.6) and the disease control rate was 59.3% (32/54; 95% CI, 45.0–72.4). One patient had a complete response. The median progression-free survival and overall survival were 2.9 months (95% CI, 2.4–3.6) and 9.2 months (95% CI, 6.9–11.4), respectively. The most common grade 3/4 toxicities were neutropenia (49.1%), leucopenia (20.0%), lymphopenia (10.9%), and peripheral sensory neuropathy (23.6%). There were no treatment-related deaths. Nab-paclitaxel, given every 3 weeks, showed promising activity against previously treated unresectable or recurrent gastric cancers, with well-tolerated toxicities. (Trial registration, ClinicalTrials.gov: NCT00661167).
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影响因子：
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