Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.
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).
In 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).
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.
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.
本 III 期试验比较了白蛋白结合型紫杉醇（nab-紫杉醇）联合卡铂与溶剂型紫杉醇（sb-紫杉醇）联合卡铂在晚期非小细胞肺癌（NSCLC）患者中的疗效和安全性。
共纳入 1052 例未经治疗的 IIIB 期至 IV 期 NSCLC 患者，按照 1:1 的比例随机分为nab-PC 组（每周给予 100mg/m2nab-紫杉醇和卡铂 AUC 6）或 sb-PC 组（每周给予 200mg/m2sb-紫杉醇和卡铂 AUC 6）。主要终点为客观总缓解率（ORR）。
基于独立评估，nab-PC 组的 ORR 显著高于 sb-PC 组（33%比 25%；缓解率比，1.313；95%CI，1.082 至 1.593；P=0.005），且在鳞状组织学患者中（41%比 24%；缓解率比，1.680；95%CI，1.271 至 2.221；P<0.001）。nab-PC 组在非鳞状组织学患者中的疗效与 sb-PC 组相当（ORR，26%比 25%；P=0.808）。无进展生存期（中位 6.3 个月比 5.8 个月；风险比 [HR]，0.902；95%CI，0.767 至 1.060；P=0.214）和总生存期（中位 12.1 个月比 11.2 个月；HR，0.922；95%CI，0.797 至 1.066；P=0.271）在 nab-PC 组与 sb-PC 组之间分别有大约 10%的改善。70 岁及以上的患者和北美地区的患者，与 sb-PC 组相比，nab-PC 组的 OS 显著增加。nab-PC 组的 3 级及以上神经病变、中性粒细胞减少症、关节痛和肌痛发生率显著降低，sb-PC 组的血小板减少症和贫血发生率显著降低。
在晚期 NSCLC 患者中，nab-PC 作为一线治疗药物，与 sb-PC 相比，疗效显著提高，达到了主要终点，ORR 显著提高。与 sb-PC 相比，nab-PC 引起的神经病变更少。
