Department of Biostatistics and Computational Biology, CLSB 11007, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115, USA.
J Clin Oncol. 2010 Feb 20;28(6):949-54. doi: 10.1200/JCO.2009.25.4482. Epub 2010 Jan 19.
PURPOSE Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor (VEGF) with demonstrated efficacy in combination with carboplatin and paclitaxel (PCB) for the treatment of advanced non-small-cell lung cancer (NSCLC). Administration of bevacizumab is postulated to decrease nitric oxide synthesis and lead to hypertension, which may be a physiological sign that the VEGF pathway is more actively being blocked and could result in improved outcomes. PATIENTS AND METHODS Eastern Cooperative Oncology Group (ECOG) 4599 randomly assigned patients with nonsquamous NSCLC to carboplatin and paclitaxel (PC) versus PCB. Hypertensive patients were compared with nonhypertensive patients with respect to overall survival (OS) and progression-free survival (PFS) using blood pressure data and adverse event data separately. High blood pressure (HBP) by the end of cycle 1 was defined as blood pressure > 150/100 at any previous time or at least a 20-mmHg increase in diastolic blood pressure from baseline. Results In a multivariable Cox model adjusting for HBP as a time-varying covariate, comparing those on PCB with HBP with those on PC gave an OS hazard ratio (HR) of 0.60 (95% CI, 0.43 to 0.81; P = .001); comparing those on PCB without HBP with those on PC alone, the OS HR was 0.86 (95% CI, 0.74 to 1.00; P = .05). Comparing the PCB HBP group with PC gave an adjusted PFS HR of 0.54 (95% CI, 0.41 to 0.73; P < .0001) and comparing those on PCB without HBP to those on PC, the HR was 0.72 (95% CI, 0.62 to 0.84; P < .0001). The 6-month cumulative incidence of hypertension was 6.2% (95% CI, 3.9% to 8.6%). CONCLUSION Data from ECOG 4599 suggest that onset of HBP during treatment with PCB may be associated with improved outcomes, and additional studies of the downstream effects of VEGF suppression and hypertension are needed.
贝伐单抗是一种针对血管内皮生长因子(VEGF)的单克隆抗体,与卡铂和紫杉醇(PCB)联合用于治疗晚期非小细胞肺癌(NSCLC)具有显著疗效。贝伐单抗的给药被假设为降低一氧化氮合成并导致高血压,这可能是 VEGF 途径更活跃地被阻断的生理标志,并且可能导致改善的结果。
东部合作肿瘤组(ECOG)4599 将非鳞状 NSCLC 患者随机分配至卡铂和紫杉醇(PC)与 PCB 组。根据血压数据和不良事件数据,分别比较高血压患者和非高血压患者的总生存期(OS)和无进展生存期(PFS)。第 1 周期结束时的高血压(HBP)定义为任何先前时间血压> 150/100mmHg,或与基线相比舒张压至少升高 20mmHg。
在调整 HBP 作为时变协变量的多变量 Cox 模型中,与 PCB 上有 HBP 的患者相比,PC 上的患者 OS 危险比(HR)为 0.60(95%CI,0.43 至 0.81;P =.001);与单独 PC 相比,无 HBP 的 PCB 患者的 OS HR 为 0.86(95%CI,0.74 至 1.00;P =.05)。与 PC 相比,PCB HBP 组的调整后 PFS HR 为 0.54(95%CI,0.41 至 0.73;P <.0001),与单独 PC 相比,无 HBP 的 PCB 患者的 HR 为 0.72(95%CI,0.62 至 0.84;P <.0001)。高血压的 6 个月累积发生率为 6.2%(95%CI,3.9%至 8.6%)。
ECOG 4599 的数据表明,PCB 治疗期间 HBP 的发生可能与改善的结果相关,需要进一步研究 VEGF 抑制和高血压的下游影响。