Centre François Baclesse, Caen, France.
Lung Cancer. 2011 Dec;74(3):474-80. doi: 10.1016/j.lungcan.2011.05.004. Epub 2011 Jun 15.
This open-label, phase II study evaluated the antitumor activity and safety of sunitinib monotherapy as maintenance treatment following first-line chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Following treatment with standard doublet chemotherapy (paclitaxel and carboplatin), patients received oral sunitinib (starting dose 50mg/day) in 6-week cycles (Schedule 4/2: 4 weeks on treatment, 2 weeks off treatment) until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was probability of survival at 1 year ≥55%. Of 84 patients who received first-line chemotherapy, 66 (79%) received sunitinib maintenance therapy (median sunitinib cycles started: 2 [range 1-20]). Probability of survival at 1 year was 40.5% (95% confidence interval [CI]: 29.8, 51.0). Median overall survival was 10.4 months (95% CI: 8.0, 12.2). The objective response rate was 27.4% (95% CI: 18.2, 38.2). The most frequently reported all-causality adverse events of any grade during sunitinib maintenance therapy were fatigue/asthenia (55%), diarrhea (36%), and nausea (32%). These data suggest that maintenance therapy may have value in NSCLC, although the primary endpoint of the study was not met.
这项开放标签、二期研究评估了舒尼替尼单药作为局部晚期或转移性非小细胞肺癌（NSCLC）一线化疗后的维持治疗的抗肿瘤活性和安全性。在接受标准双联化疗（紫杉醇和顺铂）治疗后，患者接受舒尼替尼（起始剂量为 50mg/天）的 6 周周期（方案 4/2：治疗 4 周，停药 2 周）治疗，直至疾病进展、不可接受的毒性或患者撤回同意。主要终点是 1 年生存率≥55%的概率。在接受一线化疗的 84 名患者中，有 66 名（79%）接受了舒尼替尼维持治疗（中位开始舒尼替尼周期数：2 [范围 1-20]）。1 年生存率为 40.5%（95%置信区间 [CI]：29.8, 51.0）。中位总生存期为 10.4 个月（95%CI：8.0, 12.2）。客观缓解率为 27.4%（95%CI：18.2, 38.2）。在舒尼替尼维持治疗期间，任何级别的最常报告的所有原因不良事件是疲劳/乏力（55%）、腹泻（36%）和恶心（32%）。这些数据表明，维持治疗可能对 NSCLC 有价值，尽管研究的主要终点未达到。
