Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-0021, Japan.
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
Cancer Chemother Pharmacol. 2019 Aug;84(2):351-358. doi: 10.1007/s00280-019-03843-0. Epub 2019 Apr 16.
Few studies have investigated the clinical efficacy of third- and later-line of chemotherapy after standard chemotherapy for previously treated advanced non-small cell lung cancer (NSCLC). We prospectively evaluated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) following standard chemotherapies for previously treated advanced NSCLC.
The eligible patients having adequate organ functions with performance status 0-2 were enrolled after completing standard chemotherapy. They received weekly nab-paclitaxel 100 mg/m intravenously on days 1, 8, and 15 every 3 weeks. The primary end point was objective response rate (ORR). Median progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated as secondary end points.
This trial was discontinued because of late accrual. Twenty two patients were enrolled from April 2013 and February 2019. The total ORR was 22.7% [95% CI 7.8-45.4] and disease control rate (DCR) was 81.8% [95% CI 59.7-94.8]. Median PFS was 3.4 months [95% CI 2.3-4.1] and median OS was 7.4 months [95% CI 4.2-10.7]. Median follow-up interval was 6.7 months hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and neutropenia (32%), while the most frequent nonhematological AEs were fatigue (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were observed in only one patient.
Nab-paclitaxel may be a safe and effective later-line chemotherapeutic option for previously treated advanced NSCLC after standard of chemotherapies based on other trials.
鲜有研究调查过先前治疗的晚期非小细胞肺癌（NSCLC）患者在标准化疗后使用三线及以上化疗的临床疗效。我们前瞻性评估了纳米白蛋白结合紫杉醇（nab-紫杉醇）在先前治疗的晚期 NSCLC 患者接受标准化疗后的疗效和安全性。
在完成标准化疗后，具有足够器官功能和状态 0-2 的合格患者入组。他们每 3 周接受一次nab-紫杉醇 100mg/m 静脉滴注，第 1、8 和 15 天，每周一次。主要终点是客观缓解率（ORR）。中位无进展生存期（PFS）、总生存期（OS）和不良事件（AE）作为次要终点进行评估。
由于入组较晚，该试验被终止。2013 年 4 月至 2019 年 2 月共入组 22 例患者。总 ORR 为 22.7%[95%CI7.8-45.4]，疾病控制率（DCR）为 81.8%[95%CI59.7-94.8]。中位 PFS 为 3.4 个月[95%CI2.3-4.1]，中位 OS 为 7.4 个月[95%CI4.2-10.7]。中位随访间隔为 6.7 个月。3/4 级血液学 AE 包括贫血（18%）、白细胞减少（18%）和中性粒细胞减少（32%），而最常见的非血液学 AE 是疲劳（50%）和周围神经病（36.4%）。仅 1 例患者发生与治疗相关的严重 AE。
基于其他试验，nab-紫杉醇可能是先前治疗的晚期 NSCLC 患者在标准化疗后三线及以上化疗的一种安全有效的选择。
