JCO：白蛋白结合紫杉醇治疗NSCLC优于溶剂型紫杉醇

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JCO：白蛋白结合紫杉醇治疗NSCLC优于溶剂型紫杉醇
2012-05-04
为了比较白蛋白结合紫杉醇（nab-PC）加卡铂与溶剂型紫杉醇（sb-PC）加卡铂治疗晚期非小细胞肺癌（NSCLC）的疗效和安全性，来自美国北卡罗莱纳大学的Mark A. Socinski等人进行了一项III期临床试验。研究结果近期在线发表在JCO上。

此项研究纳入了1052例未经治疗的IIIB期和IV期NSCLC患者。这些患者按1:1比例被随机分为2组。1组予以nab-PC 100 mg/m2联合卡铂（浓度-时间曲线（AUC）下面积为6），每3周化疗1次；另外1组予以sb-PC200 mg/m2联合卡铂（AUC为6），每3周化疗1次。主要终点是总体客观应答率（ORR）。

研究发现nab-PC组的ORR显著高于sb-PC（分别为33％和25％；应答率比：1.313；95％CI：1.082-1.593，P= 0.005），在鳞癌患者中分别为41％和24％;应答率比1.680；95％CI：1.271-2.221，P<0.001。而在非鳞癌患者中，nab-PC疗效与SB-PC相似（分别为26％和25％，P=0.808）。nab-PC能够提高10%的无进展生存时间（中位数分别为6.3月和5.8个月;风险比[HR]：0.902；95％CI：0.767-1.060，P=0.214）和总生存时间（OS；中位数分别为12.1月和11.2个月；HR：0.922；95％CI：0.797-1.066，P=0.271）。对于≥70岁的患者以及来自北美的患者，nab-PC相比sb-PC可以显著提高OS。在nab-PC组中，≥3级的神经病变，白细胞减少，关节痛以及肌痛发生率显著减少，而在sb-PC组，血小板减少和贫血的发生率较低。

由此可得出结论：nab-PC用于一线治疗晚期非小细胞肺癌患者是非常有效的，可以显著改善ORR。nab-PC的神经病变也低于sb-PC。

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相关文献
Weekly nab-Paclitaxel in Combination With Carboplatin Versus Solvent-Based Paclitaxel Plus Carboplatin as First-Line Therapy in Patients With Advanced Non-Small-Cell Lung Cancer: Final Results of a Phase III Trial.
J Clin Oncol 2012 Apr;:

Socinski MA Bondarenko I Karaseva NA Makhson AM Vynnychenko I Okamoto I Hon JK Hirsh V Bhar P Zhang H Iglesias JL Renschler MF

Mark A. Socinski, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC; Igor Bondarenko, City Hospital #4, Dnepropetrovsk; Igor Vynnychenko, Regional Oncology Center, Sumy, Ukraine; Nina A. Karaseva, City Oncology Center, St. Petersburg; Anatoly M. Makhson, City Oncology Hospital #62, Moscow, Russia; Isamu Okamoto, Kinki University Faculty of Medicine, Osaka-Sayama, Japan; Jeremy K. Hon, Clearview Cancer Institute, Huntsville, AL; Vera Hirsh, McGill University, Montreal, Quebec, Canada; Paul Bhar, Hui Zhang, Jose L. Iglesias, and Markus F. Renschler, Celgene, Summit, NJ.

Abstract
PURPOSEThis phase III trial compared the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin with solvent-based paclitaxel (sb-paclitaxel) plus carboplatin in advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODSIn all, 1,052 untreated patients with stage IIIB to IV NSCLC were randomly assigned 1:1 to receive 100 mg/m(2) nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks (nab-PC) or 200 mg/m(2) sb-paclitaxel plus carboplatin AUC 6 once every 3 weeks (sb-PC). The primary end point was objective overall response rate (ORR).ResultsOn the basis of independent assessment, nab-PC demonstrated a significantly higher ORR than sb-PC (33% v 25%; response rate ratio, 1.313; 95% CI, 1.082 to 1.593; P = .005) and in patients with squamous histology (41% v 24%; response rate ratio, 1.680; 95% CI, 1.271 to 2.221; P &lt; .001). nab-PC was as effective as sb-PC in patients with nonsquamous histology (ORR, 26% v 25%; P = .808). There was an approximately 10% improvement in progression-free survival (median, 6.3 v 5.8 months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P = .214) and overall survival (OS; median, 12.1 v 11.2 months; HR, 0.922; 95% CI, 0.797 to 1.066; P = .271) in the nab-PC arm versus the sb-PC arm, respectively. Patients ≥ 70 years old and those enrolled in North America showed a significantly increased OS with nab-PC versus sb-PC. Significantly less grade ≥ 3 neuropathy, neutropenia, arthralgia, and myalgia occurred in the nab-PC arm, and less thrombocytopenia and anemia occurred in the sb-PC arm. CONCLUSIONThe administration of nab-PC as first-line therapy in patients with advanced NSCLC was efficacious and resulted in a significantly improved ORR versus sb-PC, achieving the primary end point. nab-PC produced less neuropathy than sb-PC.