Weiss Jared, Force Rex W, Pugmire Brook A, Peterson Teri, Faria Claudio, Margunato-Debay Sandra, Patel Manish B
Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.
improveRx, Pocatello, ID.
Clin Lung Cancer. 2017 Jul;18(4):372-380.e1. doi: 10.1016/j.cllc.2016.12.008. Epub 2016 Dec 22.
Weekly (qw) nanoparticle albumin-bound (nab)-paclitaxel was approved for advanced non-small-cell lung cancer based on the results from a phase III trial in which nab-paclitaxel/carboplatin demonstrated a significantly greater response rate compared with paclitaxel/carboplatin every 3 weeks (q3w). Little information exists on relative real-world results.
The present retrospective study used data from a national electronic medical record database. Patients receiving first-line nab-paclitaxel qw, paclitaxel qw, or paclitaxel q3w for stage IV non-small-cell lung cancer (NSCLC) were identified. The total cumulative dose, time to treatment discontinuation (TTD), and database persistence (a proxy measure for survival) were analyzed for all patients and for the squamous and elderly subgroups.
A total of 114, 208, and 153 patients received nab-paclitaxel qw, paclitaxel qw, and paclitaxel q3w, respectively. In the corresponding treatment arms, the median age was 72, 69, and 67 years; 56%, 48%, and 37% were aged ≥ 70 years; and 75%, 43%, and 23% had squamous cell NSCLC. The total cumulative dose was significantly greater with nab-paclitaxel qw. The TTD was longer with nab-paclitaxel qw than with paclitaxel qw (hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.40-0.72; P < .001) or with paclitaxel q3w (HR, 0.53; 95% CI, 0.38-0.73; P < .001). Database persistence was longer with nab-paclitaxel qw than with paclitaxel qw (HR, 0.56; 95% CI, 0.39-0.79; P = .001) or with paclitaxel q3w (HR, 0.52; 95% CI, 0.34-0.78; P = .002). The TTD after experiencing any hematologic adverse event was longer with nab-paclitaxel qw. The findings were consistent across the subgroup analyses.
In a real-world setting, nab-paclitaxel qw was associated with a significantly greater cumulative dose and significantly longer TTD and database persistence compared with paclitaxel qw and paclitaxel q3w.
基于一项III期试验的结果,纳米白蛋白结合型(nab)紫杉醇每周给药(qw)方案被批准用于晚期非小细胞肺癌,该试验中nab紫杉醇/卡铂方案相较于紫杉醇/卡铂每3周给药(q3w)方案显示出显著更高的缓解率。关于相对真实世界结果的信息较少。
本回顾性研究使用了来自国家电子病历数据库的数据。确定了接受一线nab紫杉醇qw、紫杉醇qw或紫杉醇q3w治疗IV期非小细胞肺癌(NSCLC)的患者。分析了所有患者以及鳞状细胞癌和老年亚组患者的总累积剂量、治疗中断时间(TTD)和数据库留存时间(生存的替代指标)。
分别有114、208和153例患者接受nab紫杉醇qw、紫杉醇qw和紫杉醇q3w治疗。在相应的治疗组中,中位年龄分别为72岁、69岁和67岁;年龄≥70岁的患者分别占56%、48%和37%;鳞状细胞NSCLC患者分别占75%、43%和23%。nab紫杉醇qw的总累积剂量显著更高。nab紫杉醇qw的TTD长于紫杉醇qw(风险比[HR],0.54;95%置信区间[CI],0.40 - 0.72;P <.001)或紫杉醇q3w(HR,0.53;95% CI,0.38 - 0.73;P <.001)。nab紫杉醇qw的数据库留存时间长于紫杉醇qw(HR,0.56;95% CI,0.39 - 0.79;P =.001)或紫杉醇q3w(HR,0.52;95% CI,0.34 - 0.78;P =.002)。经历任何血液学不良事件后的TTD,nab紫杉醇qw更长。亚组分析的结果一致。
在真实世界中,与紫杉醇qw和紫杉醇q3w相比,nab紫杉醇qw的累积剂量显著更高,TTD和数据库留存时间显著更长。