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
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
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DOI：
10.1200/jco.2011.39.5848
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发表时间：
2012-06-10
影响因子：
45.3
通讯作者：
Renschler, Markus F.
中科院分区：
文献类型：
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作者：
Socinski, Mark A.;Bondarenko, Igor;Renschler, Markus F.
目的本III期临床试验比较白蛋白结合紫杉醇的疗效和安全性（白蛋白结合型紫杉醇）加卡铂与溶剂型紫杉醇（sb-紫杉醇）加卡铂治疗晚期非小细胞肺癌（NSCLC）的患者和方法总共有1，052名IIIB至IV期NSCLC的未经治疗的患者被随机分配1：1接受100 mg/m2白蛋白结合型紫杉醇每周一次和卡铂浓度-时间曲线下面积（AUC）6每3周一次（nab-PC）或200 mg/m2 sb-紫杉醇加卡铂AUC 6，每3周一次（sb-PC）。结果在独立评估的基础上，nab-PC的客观总有效率（ORR）明显高于sb-PC（33%对25%;缓解率比，1.313; 95% CI，1.082至1.593; P = .005）和鳞状组织学患者（41%对24%;反应率比，1.680; 95%CI，1.271至2.221; P <0.001）。nab-PC在非鳞状组织学患者中与sb-PC一样有效（ORR，26% vs25%; P = .808）。无进展生存率提高了约10%，（中位数，6.3 vs 5.8个月;风险比[HR]，0.902; 95% CI，0.767 - 1.060; P = 0.214）和总生存期（OS;中位数，12.1 v11.2个月; HR，0.922; 95%CI，0.797 - 1.066; P = 0.271）。年龄>= 70岁的患者和在北美招募的患者显示，与sb-PC相比，nab-PC的OS显著增加。nab-PC组中发生的>= 3级神经病变、中性粒细胞减少、关节痛和肌痛显著减少，而sb-PC组中发生的血小板减少和贫血较少。nab-PC比sb-PC产生更少的神经病变。
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/m2 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 < .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.