Department of Medicine (Cancer Research), West German Tumor Center, University Hospital of University Duisburg-Essen, Essen, Germany.
Institut Gustave Roussy, Villejuif, France.
Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.
The objective of this multicenter, prospective uncontrolled phase II trial was to determine efficacy, safety and tolerability of vatalanib, an oral angiogenesis inhibitor targeting all known vascular endothelial growth factor receptors, in the second-line treatment of non-small-cell lung cancer (NSCLC).
Patients with stage IIIB/IV NSCLC-proven tumor progression during or after one platinum-based chemotherapy regimen received a fixed dose of 1250 mg vatalanib either once-daily dosing (QD) or two divided daily dosing (TDD: 500 mg a.m. + 750 mg p.m.) until disease progression or unacceptable toxicity. Primary end point was the disease control rate (DCR) at 12 weeks.
Fifty-four and 58 patients were enrolled to the QD and TDD arms. DCR at 12 weeks was 35% in the QD and 37% in the TDD arm. The best overall response included one (2%) patient with confirmed partial response with QD and three (5%) with TDD. Median progression-free survival and overall survival were 2.1/7.3 months in the QD arm and 2.8/9.0 months with TDD arm. This therapy showed a moderate toxicity profile for the majority of patients.
In the chosen patient population, vatalanib QD and TDD dosing demonstrated potential benefits in tumor size reduction, DCR, and survival.
本多中心、前瞻性、非对照 II 期临床试验旨在评估口服血管生成抑制剂凡德他尼（可靶向所有已知血管内皮生长因子受体）在铂类化疗失败的非小细胞肺癌（NSCLC）二线治疗中的疗效、安全性和耐受性。
IIIb/IV 期 NSCLC 患者在铂类为基础的化疗方案期间或之后证实肿瘤进展，接受凡德他尼 1250mg 固定剂量治疗，每日一次（QD）或每日两次（TDD：早上 500mg+晚上 750mg），直至疾病进展或不可接受的毒性。主要终点为 12 周时的疾病控制率（DCR）。
QD 和 TDD 组分别入组 54 和 58 例患者。12 周时 DCR 分别为 35%和 37%。最佳总缓解包括 QD 组 1 例（2%）患者确认部分缓解和 TDD 组 3 例（5%）患者确认部分缓解。QD 组中位无进展生存期和总生存期分别为 2.1/7.3 个月，TDD 组分别为 2.8/9.0 个月。该治疗方案对大多数患者显示出中等毒性谱。
在选择的患者人群中，凡德他尼 QD 和 TDD 剂量方案在肿瘤大小缩小、DCR 和生存方面显示出一定的获益。
