BACKGROUND The selection of later-line treatment for older patients with AJCC (version 7) stage IV non-small cell lung cancer (NSCLC) remains controversial. Nanoparticle albumin-bound (nab)-paclitaxel is approved with carboplatin for the first-line treatment of patients with NSCLC and subgroup analysis of phase 3 data has suggested superior survival in older patients. METHODS The authors conducted a phase 2 study of nab-paclitaxel in 42 patients aged ≥70 years who had been treated previously with a platinum doublet regimen; patients also could have received a PD-1 inhibitor. The primary endpoint of the current study was grade 3 to 5 toxicity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). In addition to response rate, progression-free survival (PFS), and overall survival (OS), geriatric assessments also were performed before and during treatment, associations between baseline sarcopenia and outcomes were explored, and changes in T lymphocyte p16 before and during treatment were measured. The authors also performed a retrospective subgroup analysis of 19 older patients who were treated with nab-paclitaxel as part of a larger, randomized, phase 2 study; data were not combined. RESULTS The rate of grade 3 to 5 toxicities was 33.7%. The most common grade 3 to 5 toxicities were decreased white blood cell count (11.9%), neutropenia (9.5%), and fatigue (11.9%). The response rate was 34.2% (2.6% complete response rate and 31.6% partial response rate). The median PFS was 5.2 months and the median OS was 9.3 months. Adverse prognostic factors were common: 42% of patients were frail and 39% of patients were prefrail, whereas 21% had an Eastern Cooperative Oncology Group performance status of 2 and 27% were sarcopenic. Only frailty was found to be predictive of inferior survival. A subgroup analysis of 19 older patients treated with nab-paclitaxel alone in a prior trial demonstrated a response rate of 15.8%, a PFS of 4.2 months, and an OS of 13.6 months. CONCLUSIONS Fit and prefrail older patients with stage IV NSCLC should be considered for treatment with nab-paclitaxel after disease progression with doublet chemotherapy.

中文翻译：

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铂类双线化疗后疾病进展的老年非小细胞肺癌患者中的纳布紫杉醇。

背景技术对于年龄较大的AJCC（第7版）IV期非小细胞肺癌（NSCLC）患者，其后线治疗的选择仍存在争议。纳米颗粒白蛋白结合的（nab）-紫杉醇已被卡铂批准用于NSCLC患者的一线治疗，并且3期数据的亚组分析表明，老年患者的生存率更高。方法作者对42例≥70岁的先前曾接受铂类双联疗法治疗的患者进行了nab-紫杉醇的2期研究。患者也可能接受了PD-1抑制剂。本研究的主要终点是3至5级毒性（根据美国国家癌症研究所不良事件通用术语标准[4.0版]）。除了反应率，无进展生存期（PFS）和总体生存期（OS），在治疗之前和期间也进行了老年医学评估，探讨了基线肌肉减少症与预后之间的关联，并测量了治疗之前和期间T淋巴细胞p16的变化。作者还对19名接受nab-紫杉醇治疗的老年患者进行了回顾性亚组分析，这是一项较大的随机2期研究的一部分。数据未合并。结果3〜5级毒性反应率为33.7％。最常见的3至5级毒性是白细胞数量减少（11.9％），中性粒细胞减少症（9.5％）和疲劳（11.9％）。缓解率为34.2％（完全缓解率为2.6％，部分缓解率为31.6％）。PFS的中位数为5.2个月，OS的中位数为9.3个月。不良预后因素很普遍：42％的患者体弱，39％的患者体弱，东部合作肿瘤小组中21％的患者的表现状态为2，而肌肉缺乏症的患者为27％。发现只有虚弱才能预示生存率低下。在先前的试验中，对19位单独接受纳布紫杉醇治疗的老年患者进行的亚组分析显示，缓解率为15.8％，PFS为4.2个月，OS为13.6个月。结论病情恶化并接受双重化疗后，应考虑对体质和体弱的IV期NSCLC老年患者进行nab-紫杉醇治疗。