**点破**：培美曲塞联合卡铂和贝伐珠单抗加培美曲塞和贝伐珠单抗维持治疗对比紫杉醇联合卡铂和贝伐珠单抗加贝伐珠单抗维持治疗用于 IIIB 或 IV 期非鳞状非小细胞肺癌患者的随机 III 期研究。
PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer.
机构信息
Jyoti D. Patel, Northwestern University; Philip Bonomi, Rush University Medical Center, Chicago, IL; Mark A. Socinski, University of Pittsburgh, Pittsburgh, PA; Edward B. Garon, University of California at Los Angeles, Los Angeles, CA; Craig H. Reynolds, US Oncology Research, Ocala, FL; David R. Spigel, Sarah Cannon Research Institute-Tennessee Oncology, Nashville, TN; Mark R. Olsen, Tulsa Cancer Institute, Tulsa, OK; Robert C. Hermann, Northwest Georgia Oncology Centers, Marietta, GA; Robert M. Jotte, Rocky Mountain Cancer Centers, Denver, CO; Thaddeus Beck, Highlands Oncology Group, Fayetteville, AR; Donald A. Richards, US Oncology Research, Tyler, TX; Susan C. Guba, Jingyi Liu, Bente Frimodt-Moller, and William J. John, Eli Lilly, Indianapolis, IN; Coleman K. Obasaju and Eduardo J. Pennella, Lilly USA, Indianapolis, IN; and Ramaswamy Govindan, Washington University School of Medicine, St. Louis, MO.
出版信息
J Clin Oncol. 2013 Dec 1;31(34):4349-57. doi: 10.1200/JCO.2012.47.9626. Epub 2013 Oct 21.
PURPOSE
PointBreak (A Study of Pemetrexed, Carboplatin and Bevacizumab in Patients With Nonsquamous Non-Small Cell Lung Cancer) compared the efficacy and safety of pemetrexed (Pem) plus carboplatin (C) plus bevacizumab (Bev) followed by pemetrexed plus bevacizumab (PemCBev) with paclitaxel (Pac) plus carboplatin (C) plus bevacizumab (Bev) followed by bevacizumab (PacCBev) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS
Patients with previously untreated stage IIIB or IV nonsquamous NSCLC and Eastern Cooperative Oncology Group performance status of 0 to 1 were randomly assigned to receive pemetrexed 500 mg/m(2) or paclitaxel 200 mg/m(2) combined with carboplatin area under the curve 6 and bevacizumab 15 mg/kg every 3 weeks for up to four cycles. Eligible patients received maintenance until disease progression: pemetrexed plus bevacizumab (for the PemCBev group) or bevacizumab (for the PacCBev group). The primary end point of this superiority study was overall survival (OS).
RESULTS
Patients were randomly assigned to PemCBev (n = 472) or PacCBev (n = 467). For PemCBev versus PacCBev, OS hazard ratio (HR) was 1.00 (median OS, 12.6 v 13.4 months; P = .949); progression-free survival (PFS) HR was 0.83 (median PFS, 6.0 v 5.6 months; P = .012); overall response rate was 34.1% versus 33.0%; and disease control rate was 65.9% versus 69.8%. Significantly more study drug-related grade 3 or 4 anemia (14.5% v 2.7%), thrombocytopenia (23.3% v 5.6%), and fatigue (10.9% v 5.0%) occurred with PemCBev; significantly more grade 3 or 4 neutropenia (40.6% v 25.8%), febrile neutropenia (4.1% v 1.4%), sensory neuropathy (4.1% v 0%), and alopecia (grade 1 or 2; 36.8% v 6.6%) occurred with PacCBev.
CONCLUSION
OS did not improve with the PemCBev regimen compared with the PacCBev regimen, although PFS was significantly improved with PemCBev. Toxicity profiles differed; both regimens demonstrated tolerability.
目的
PointBreak（培美曲塞、卡铂和贝伐单抗治疗非鳞状非小细胞肺癌患者的研究）比较了培美曲塞（Pem）联合卡铂（C）联合贝伐单抗（Bev）序贯培美曲塞联合贝伐单抗（PemCBev）与紫杉醇（Pac）联合卡铂（C）联合贝伐单抗（Bev）序贯贝伐单抗（PacCBev）在晚期非鳞状非小细胞肺癌（NSCLC）患者中的疗效和安全性。
方法
未经治疗的 IIIB 期或 IV 期非鳞状 NSCLC 患者和东部合作肿瘤学组表现状态 0 至 1 分的患者被随机分配接受培美曲塞 500mg/m2 或紫杉醇 200mg/m2 联合卡铂曲线下面积 6 和贝伐单抗 15mg/kg，每 3 周 1 次，最多 4 个周期。符合条件的患者接受维持治疗，直至疾病进展：培美曲塞联合贝伐单抗（用于 PemCBev 组）或贝伐单抗（用于 PacCBev 组）。该优效性研究的主要终点是总生存期（OS）。
结果
患者被随机分配至 PemCBev（n=472）或 PacCBev（n=467）组。对于 PemCBev 与 PacCBev，OS 危险比（HR）为 1.00（中位 OS，12.6 与 13.4 个月；P=0.949）；无进展生存期（PFS）HR 为 0.83（中位 PFS，6.0 与 5.6 个月；P=0.012）；总缓解率为 34.1%与 33.0%；疾病控制率为 65.9%与 69.8%。PemCBev 组更常见 3 或 4 级贫血（14.5%比 2.7%）、血小板减少症（23.3%比 5.6%）和疲劳（10.9%比 5.0%）；PacCBev 组更常见 3 或 4 级中性粒细胞减少症（40.6%比 25.8%）、发热性中性粒细胞减少症（4.1%比 1.4%）、感觉神经病变（4.1%比 0%）和脱发（1 或 2 级；36.8%比 6.6%）。
结论
与 PacCBev 方案相比，PemCBev 方案并未改善 OS，尽管 PemCBev 方案的 PFS 显著改善。毒性谱不同；两种方案均具有耐受性。
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