Saxena Ashish, Schneider Bryan J, Christos Paul J, Audibert Lauren F, Cagney Jennifer M, Scheff Ronald J
Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medicine, 1305 York Avenue, 7th Floor, New York, NY, 10021, USA.
Division of Hematology/Oncology, Department of Internal Medicine, University of Michigan Health System, Cancer Center Floor B1, Reception C, 1500 E Medical Center Dr, Ann Arbor, MI, 48109, USA.
Med Oncol. 2016 Feb;33(2):13. doi: 10.1007/s12032-015-0728-2. Epub 2016 Jan 9.
The role of single-agent nab-paclitaxel in relapsed or platinum-refractory advanced non-small cell lung cancer (NSCLC) has not been well reported in Western populations. We reviewed our own institution's experience using nab-paclitaxel in these settings. We analyzed the records of stage IV NSCLC patients with relapsed or platinum-refractory disease treated with single-agent nab-paclitaxel at Weill Cornell Medical College between October 2008 and December 2013. The primary endpoint of the study was treatment failure-free survival (TFFS), defined as the time from the start of nab-paclitaxel therapy to discontinuation of the drug for any reason. The best overall response was recorded for each patient, and overall response and disease control rates were calculated. Thirty-one stage IV NSCLC patients received a median of 4 cycles (range 1-40) of nab-paclitaxel. Dose reduction or drug discontinuation due to toxicity occurred in 10 patients, mainly because of grade 2/3 fatigue or peripheral neuropathy. The overall response rate was 16.1 %, and the disease control rate was 64.5 %. Median TFFS was 3.5 months (95 % CI 1.3-5.3 months). No statistically significant difference in TFFS based on line of therapy or prior taxane exposure was identified. There was a statistically significant decrease in TFFS for patients with non-adenocarcinoma histology, although there were only five patients in this group. There was a trend toward reduction in the risk of treatment failure with increasing age. One patient remained on nab-paclitaxel therapy for over 3 years. Single-agent nab-paclitaxel was well tolerated and demonstrated efficacy in advanced NSCLC patients with relapsed or platinum-refractory disease. Further prospective clinical trials with nab-paclitaxel in these settings are warranted.
在西方人群中,单药白蛋白结合型紫杉醇在复发或铂类难治性晚期非小细胞肺癌(NSCLC)中的作用尚未得到充分报道。我们回顾了我们机构在这些情况下使用白蛋白结合型紫杉醇的经验。我们分析了2008年10月至2013年12月在威尔康奈尔医学院接受单药白蛋白结合型紫杉醇治疗的复发或铂类难治性IV期NSCLC患者的记录。该研究的主要终点是无治疗失败生存期(TFFS),定义为从白蛋白结合型紫杉醇治疗开始到因任何原因停药的时间。记录每位患者的最佳总体反应,并计算总体反应率和疾病控制率。31例IV期NSCLC患者接受了中位数为4个周期(范围1 - 40)的白蛋白结合型紫杉醇治疗。10例患者因毒性反应出现剂量减少或停药,主要原因是2/3级疲劳或周围神经病变。总体反应率为16.1%,疾病控制率为64.5%。TFFS中位数为3.5个月(95%可信区间1.3 - 5.3个月)。未发现基于治疗线数或既往紫杉烷暴露的TFFS有统计学显著差异。非腺癌组织学类型的患者TFFS有统计学显著下降,尽管该组仅有5例患者。随着年龄增加,治疗失败风险有降低趋势。1例患者接受白蛋白结合型紫杉醇治疗超过3年。单药白蛋白结合型紫杉醇耐受性良好,在复发或铂类难治性晚期NSCLC患者中显示出疗效。有必要在这些情况下进一步开展白蛋白结合型紫杉醇的前瞻性临床试验。