Efficacy and safety of nanoparticle albumin-bound paclitaxel monotherapy as second-line therapy of cytotoxic anticancer drugs in patients with advanced non-small cell lung cancer.
Efficacy and safety of nanoparticle albumin-bound paclitaxel monotherapy as second-line therapy of cytotoxic anticancer drugs in patients with advanced non-small cell lung cancer.
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DOI：
10.1097/md.0000000000009320
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发表时间：
2017-12
期刊：
影响因子：
1.6
通讯作者：
Ishizuka T
中科院分区：
文献类型：
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作者：
Anzai M;Morikawa M;Okuno T;Umeda Y;Demura Y;Sonoda T;Yamaguchi M;Kanno K;Shiozaki K;Ameshima S;Akai M;Ishizuka T
纳米粒白蛋白结合紫杉醇（nab-PTX），避免了与溶剂型PTX中使用的载体相关的毒性，已经在非小细胞肺癌（NSCLC）患者中显示出安全性和有效性。进行了一项II期研究，以评估nab-PTX单药治疗作为既往治疗过的晚期NSCLC的细胞毒性抗癌药物后的二线化疗的安全性和疗效。入组了32例既往接受过1种细胞毒性抗癌药物治疗方案的晚期NSCLC患者。在28天周期的第1、8和15天以100 mg/m2的剂量静脉内施用Nab-PTX。评价客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）和毒性特征。ORR为28.1%，DCR为71.9%，中位PFS为3.9个月（95%置信区间[CI] 2.7-5.1个月），中位OS为10.9个月（95% CI 9.5-12.3个月）。nab-PTX的平均相对剂量强度为77%。分别在32例患者中的11例和1例中观察到3级或4级中性粒细胞减少和3级发热性中性粒细胞减少。作为非血液学毒性，32例患者中各有2例观察到3级外周感觉神经病变和肺炎。Nab-PTX在既往接受过治疗的NSCLC患者中是一种有效且耐受性良好的方案。
Nanoparticle albumin-bound paclitaxel (nab-PTX), which avoids toxicities associated with a vehicle used in solvent-based PTX, has already shown safety and efficacy in patients with non-small cell lung cancer (NSCLC). A phase II study was performed to assess the safety and efficacy of nab-PTX monotherapy as second-line chemotherapy after cytotoxic anticancer drugs for previously treated advanced NSCLC. Thirty-two patients with advanced NSCLC who had previously undergone 1 regimen of cytotoxic anticancer drugs were enrolled. Nab-PTX was administered intravenously at a dose of 100 mg/m2 on days 1, 8, and 15 of a 28-day cycle. The objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and toxicity profile were evaluated. The ORR was 28.1%, the DCR was 71.9%, median PFS was 3.9 months (95% confidence interval [CI] 2.7–5.1 months), and median OS was 10.9 months (95% CI 9.5–12.3 months). The mean relative dose intensity of nab-PTX was 77%. Grade 3 or 4 neutropenia, and grade 3 febrile neutropenia were observed in 11 and 1 of 32 patients, respectively. As nonhematologic toxicities, grade 3 peripheral sensory neuropathy and pneumonitis were each observed in 2 of 32 patients. Nab-PTX is an active and well-tolerated regimen in patients with previously treated NSCLC.