每周给予白蛋白型紫杉醇+卡铂与溶剂型紫杉醇+卡铂作为晚期非小细胞肺癌患者一线治疗的比较：一项Ⅲ期试验的最终结果

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 100mg/m2nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3weeks (nab-PC) or 200mg/m2 sb-paclitaxel plus carboplatin AUC 6 once every 3weeks (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 5.8months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P=.214) and overall survival (OS; median, 12.1 v 11.2months; HR, 0.922; 95% CI, 0.797 to 1.066; P=.271) in the nab-PC arm versus the sb-PC arm, respectively. Patients≥70years 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.