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首页> 外文期刊>Medical oncology >A phase II clinical study of using nab-paclitaxel as second-line chemotherapy for Chinese patients with advanced non-small cell lung cancer
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A phase II clinical study of using nab-paclitaxel as second-line chemotherapy for Chinese patients with advanced non-small cell lung cancer

机译：nab-紫杉醇二线化疗治疗中国晚期非小细胞肺癌二期临床研究

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The aim of this clinical study was to evaluate the efficacy and safety of nab-paclitaxel to treat patients with advanced non-small cell lung cancer (NSCLC) who failed first-line chemotherapy. Eligible patients had advanced NSCLC and had been treated with first-line platinum-based chemotherapy but still had disease progression. Patients received nab-paclitaxel 100 mg/m(2) (i.v.) on days 1, 8 and 15 of a 28-day cycle. Primary endpoint is 6-month progression-free survival (PFS). Fifty-six patients with advanced NSCLC were enrolled in the study (55.4 % male patients, 44.6 % female patients; median age 59.6 years; ranging from 32 to 83 years). Six-month PFS rate was 18 % (95 % CI 7.8-28.7 %). Median PFS was 3.5 months (95 % CI 1.9-5.8 months). Median overall survival was 6.8 months (95 % CI 4.7-9.3 months). No complete responses were achieved. Overall response rate was 16.1 % (95 % CI 8.9-24.7 %). Grade 3 or 4 adverse events (AEs) were observed in patients receiving nab-paclitaxel. The most common grade 3 or 4 AEs were dizziness, pulmonary embolism and fatigue. Nab-paclitaxel showed clinically equivalent efficacy on patients' survivals and response rates, as compared with other FDA-approved second-line chemotherapy agents. Given the tolerability on grade 3 or 4 adverse events, nab-paclitaxel may be considered an alternative second-line treatment option for NSCLC.
机译：这项临床研究的目的是评估nab-紫杉醇治疗一线化疗失败的晚期非小细胞肺癌（NSCLC）患者的疗效和安全性。符合条件的患者患有晚期NSCLC，并接受了一线铂类化学疗法的治疗，但仍具有疾病进展。患者在28天周期的第1、8和15天接受100 mg / m（2）纳布紫杉醇（i.v.）。主要终点是6个月无进展生存期（PFS）。该研究纳入了56例晚期NSCLC患者（男性55.4％，女性44.6％;中位年龄59.6岁;年龄32至83岁）。六个月的PFS率为18％（95％CI 7.8-28.7％）。 PFS中位数为3.5个月（95％CI 1.9-5.8个月）。中位总生存期为6.8个月（95％CI 4.7-9.3个月）。没有得到完整的回应。总体缓解率为16.1％（95％CI 8.9-24.7％）。接受纳布-紫杉醇的患者观察到3级或4级不良事件（AE）。最常见的3或4级AE是头晕，肺栓塞和疲劳。与其他FDA批准的其他二线化疗药物相比，Nab-紫杉醇对患者的生存率和缓解率具有临床等效的疗效。鉴于3级或4级不良事件的耐受性，nab-紫杉醇可能被认为是NSCLC的另一种二线治疗选择。

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