Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL).
Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL).
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DOI：
10.1093/annonc/mdq020
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发表时间：
2010-09
期刊：
影响因子：
--
通讯作者：
BO17704 Study Group
中科院分区：
文献类型：
--
作者：
Reck M;von Pawel J;Zatloukal P;Ramlau R;Gorbounova V;Hirsh V;Leighl N;Mezger J;Archer V;Moore N;Manegold C;BO17704 Study Group
背景：贝伐珠单抗是一种抗血管内皮生长因子药物，与铂类化疗联合治疗一线晚期非小细胞肺癌具有临床益处。我们报告了 III 期 AVAiL 试验的最终总生存 (OS) 分析。患者和方法：患者 (n = 1043) 接受顺铂 80 mg/m2 和吉西他滨 1250 mg/m2，最多六个周期，加贝伐单抗 7.5 mg/kg (n = 345)、贝伐单抗 15 mg/kg (n = 351) 或安慰剂 (n = 347)。 3周后出现进展。主要终点是无进展生存期（PFS）； OS 是次要终点。结果：与安慰剂相比，贝伐单抗组的 PFS 显着延长，随访时间较长{风险比 (HR) [95% 置信区间 (CI)] 0.75 (0.64–0.87)，P = 0.0003 和 0.85 (0.73–1.00)，P = 0.0456}（7.5 和 15 组）分别为mg/kg组。所有治疗组的中位 OS 均 > 13 个月；然而，与安慰剂相比，贝伐单抗组的 OS 并未显着增加 [HR (95% CI) 0.93 (0.78–1.11), P = 0.420 和 1.03 (0.86–1.23), P = 0.761]，分别为 7.5 和 15 mg/kg 组。大多数患者（~62%）接受了多种研究后治疗。更新的安全性结果与之前报告的一致。结论：AVAiL 的最终分析证实了贝伐珠单抗联合顺铂-吉西他滨的疗效。 PFS 获益并未转化为显着的 OS 获益，这可能是由于有效二线疗法的大量使用。
Background: Bevacizumab, the anti-vascular endothelial growth factor agent, provides clinical benefit when combined with platinum-based chemotherapy in first-line advanced non-small-cell lung cancer. We report the final overall survival (OS) analysis from the phase III AVAiL trial. Patients and methods: Patients (n = 1043) received cisplatin 80 mg/m2 and gemcitabine 1250 mg/m2 for up to six cycles plus bevacizumab 7.5 mg/kg (n = 345), bevacizumab 15 mg/kg (n = 351) or placebo (n = 347) every 3 weeks until progression. Primary end point was progression-free survival (PFS); OS was a secondary end point. Results: Significant PFS prolongation with bevacizumab compared with placebo was maintained with longer follow-up {hazard ratio (HR) [95% confidence interval (CI)] 0.75 (0.64–0.87), P = 0.0003 and 0.85 (0.73–1.00), P = 0.0456} for the 7.5 and 15 mg/kg groups, respectively. Median OS was >13 months in all treatment groups; nevertheless, OS was not significantly increased with bevacizumab [HR (95% CI) 0.93 (0.78–1.11), P = 0.420 and 1.03 (0.86–1.23), P = 0.761] for the 7.5 and 15 mg/kg groups, respectively, versus placebo. Most patients (∼62%) received multiple lines of poststudy treatment. Updated safety results are consistent with those previously reported. Conclusions: Final analysis of AVAiL confirms the efficacy of bevacizumab when combined with cisplatin–gemcitabine. The PFS benefit did not translate into a significant OS benefit, possibly due to high use of efficacious second-line therapies.
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