近日,一个国际研究小组研究发现,对于晚期非小细胞肺癌患者,白蛋白结合型紫杉醇(nab-PC)方案的疗效要优于溶剂型紫杉醇(sb-PC)。相关论文发表在JCO杂志上。
作者指出,特别是针对鳞癌患者,nab-PC的疗效非常好,这是非常有意义的,因为这为鳞癌患者提供了一个改进的治疗方案。
此项研究纳入了1052例未经治疗的IIIB~IV期NSCLC患者。1组使用nab-PC 100 mg/m2联合卡铂,每3周化疗1次;另外1组予以sb-PC200 mg/m2联合卡铂,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为33%,显著高于sb-PC组的25%(P= 0.005)。对于鳞癌患者,nab-PC更为有效,ORR分别为41%和24%(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能够提高无进展生存期(中位数分别为6.3月和5.8个月;P=0.214)和总生存期(分别为12.1月和11.2个月;P=0.271),但无统计学差异。
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。
总而言之,nab-PC相对于sb-PC,一线治疗晚期非小细胞肺癌患者具有良好的疗效,且神经病变的毒性也较小。(生物谷Bioon.com)
doi:10.1200/JCO.2011.39.5848
PMC:
PMID:
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
Mark A. Socinski?, Igor Bondarenko, Nina A. Karaseva, Anatoly M. Makhson, Igor Vynnychenko, Isamu Okamoto, Jeremy K. Hon, Vera Hirsh, Paul Bhar, Hui Zhang, Jose L. Iglesias and Markus F. Renschler Purpose This 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 Methods In all, 1,052 untreated patients with stage IIIB to IV NSCLC were randomly assigned 1:1 to receive 100 mg/m2 nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks (nab-PC) or 200 mg/m2 sb-paclitaxel plus carboplatin AUC 6 once every 3 weeks (sb-PC). The primary end point was objective overall response rate (ORR).
Results On 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 < .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.
Conclusion The 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.