Department of Medical Oncology, Hopital Saint Andre Bordeaux University Hospital, Bordeaux, France
Department of Medicine, PUCRS School of Medicine, Porto Alegre, Brazil.
Ann Oncol. 2015 Jul;26(7):1378-84. doi: 10.1093/annonc/mdv170. Epub 2015 Apr 7.
The open-label, phase II RECORD-2 trial compared efficacy and safety of first-line everolimus plus bevacizumab (EVE/BEV) with interferon plus bevacizumab (IFN/BEV) in patients with metastatic renal cell carcinoma.
Previously untreated patients were randomized 1:1 to bevacizumab 10 mg/kg every 2 weeks with either everolimus 10 mg/day (EVE/BEV) or interferon (9 MIU 3 times/week, if tolerated) (IFN/BEV). Tumor assessments occurred every 12 weeks. The primary objective was the assessment of treatment effect on progression-free survival (PFS), based on an estimate of the chance of a subsequent phase III trial success (50% threshold for phase II success).
Baseline characteristics were balanced between the EVE/BEV (n = 182) and IFN/BEV (n = 183) arms. The median PFS was 9.3 and 10.0 months in the EVE/BEV and IFN/BEV arms, respectively (P = 0.485). The predicted probability of phase III success was 5.05% (hazard ratio = 0.91; 95% confidence interval 0.69-1.19). The median duration of exposure was 8.5 and 8.3 months for EVE/BEV and IFN/BEV, respectively. The percentage of patients discontinuing because of adverse events (AEs) was 23.4% for EVE/BEV and 26.9% for IFN/BEV. Common grade 3/4 AEs included proteinuria (24.4%), stomatitis (10.6%), and anemia (10.6%) for EVE/BEV and fatigue (17.1%), asthenia (14.4%), and proteinuria (10.5%) for IFN/BEV. The median overall survival was 27.1 months in both arms.
The efficacy of EVE/BEV and IFN/BEV appears similar. No new or unexpected safety findings were identified and, with the exception of proteinuria in about one-fourth of the population, EVE/BEV was generally well tolerated.
ClinicalTrials.gov: NCT00719264.
开放标签、二期 RECORD-2 试验比较了转移性肾细胞癌患者一线依维莫司联合贝伐单抗（EVE/BEV）与干扰素联合贝伐单抗（IFN/BEV）的疗效和安全性。
未经治疗的患者按 1:1 随机分配，分别接受贝伐单抗 10mg/kg，每 2 周 1 次，联合依维莫司 10mg/天（EVE/BEV）或干扰素（IFN/BEV，9 MIU 每周 3 次，如果耐受）。每 12 周进行肿瘤评估。主要终点是根据后续三期试验成功的可能性（二期成功的 50%阈值）评估无进展生存期（PFS）的治疗效果。
EVE/BEV（n=182）和 IFN/BEV（n=183）组之间的基线特征平衡。EVE/BEV 和 IFN/BEV 组的中位 PFS 分别为 9.3 和 10.0 个月（P=0.485）。三期成功的预测概率为 5.05%（风险比=0.91；95%置信区间 0.69-1.19）。EVE/BEV 和 IFN/BEV 的中位暴露持续时间分别为 8.5 和 8.3 个月。因不良事件（AE）而停药的患者比例分别为 23.4%（EVE/BEV）和 26.9%（IFN/BEV）。常见的 3/4 级 AE 包括蛋白尿（24.4%）、口腔炎（10.6%）和贫血（10.6%）（EVE/BEV）和疲劳（17.1%）、乏力（14.4%）和蛋白尿（10.5%）（IFN/BEV）。两个治疗组的中位总生存期均为 27.1 个月。
EVE/BEV 和 IFN/BEV 的疗效似乎相似。未发现新的或意外的安全性发现，除了大约四分之一的人群出现蛋白尿外，EVE/BEV 通常耐受性良好。
ClinicalTrials.gov：NCT00719264。
