Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE):: A randomized, phase II study
Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE):: A randomized, phase II study
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DOI：
10.1200/jco.2007.15.0672
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发表时间：
2008-09-10
影响因子：
45.3
通讯作者：
Cullen, Michael
中科院分区：
文献类型：
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作者：
Crino, Lucio;Cappuzzo, Federico;Cullen, Michael
目的这项 II 期、开放标签、平行组研究在患有晚期非小细胞肺癌 (NSCLC) 的初治老年患者中比较了吉非替尼与长春瑞滨。方法未接受化疗的患者（年龄 >= 70 岁）被随机分配至吉非替尼（250 mg/d 口服）或长春瑞滨（在 21 天周期的第 1 天和第 8 天输注 30 mg/m(2)）。主要终点是无进展生存期（PFS）。次要终点是总生存期（OS）、客观缓解率（ORR）、生活质量（QOL）、肺部症状改善（PSI）和耐受性。探索性终点包括通过荧光原位杂交 (FISH) 检测表皮生长因子受体 (EGFR) 基因拷贝数。 结果患者被随机分配至吉非替尼 (n = 97) 或长春瑞滨 (n = 99)。 PFS 的风险比（HR；吉非替尼 vs 长春瑞滨）为 1.19（95% CI，0.85 至 1.65），OS 为 0.98（95% CI，0.66 至 1.47）。 ORR 和疾病控制率分别为 3.1%（95% CI，0.6 至 8.8）和 43.3%（吉非替尼）和 5.1%（95% CI，1.7 至 11.4）和 53.5%（长春瑞滨）。总体 QOL 改善率和 PSI 率分别为 24.3% 和 36.6%（吉非替尼）以及 10.9% 和 31.0%（长春瑞滨）。在 54 名 EGFR FISH 阳性患者中，PFS 的 HR 为 3.13（95% CI，1.45 至 6.76），OS 的 HR 为 2.88（95% CI，1.21 至 6.83）。吉非替尼治疗相关的3至5级不良事件（12.8%）少于长春瑞滨（41.7%）。结论 对于未经化疗、未经选择的老年晚期NSCLC患者，吉非替尼和长春瑞滨的疗效无统计学差异，但吉非替尼具有更好的耐受性。 EGFR FISH 阳性的个体从长春瑞滨中获益比从吉非替尼中获益更多；这一意外发现需要进一步研究。
PurposeThis phase II, open-label, parallel-group study compared gefitinib with vinorelbine in chemotherapy naive elderly patients with advanced non-small-cell lung cancer (NSCLC).MethodsChemotherapy-naive patients (age >= 70 years) were randomly assigned to gefitinib (250 mg/d orally) or vinorelbine (30 mg/m(2) infusion on days 1 and 8 of a 21-day cycle). The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and tolerability. Exploratory end points included epidermal growth factor receptor (EGFR) gene copy number by fluorescent in situ hybridization (FISH).ResultsPatients were randomly assigned to gefitinib (n = 97) or to vinorelbine (n = 99). Hazard ratios (HR; gefitinib v vinorelbine) were 1.19 (95% CI, 0.85 to 1.65) for PFS and 0.98 (95% CI, 0.66 to 1.47) for OS. ORR and disease control rates were 3.1% (95% CI, 0.6 to 8.8) and 43.3% (for gefitinib) and 5.1% (95% CI, 1.7 to 11.4) and 53.5% (for vinorelbine), respectively. Overall QOL improvement and PSI rates were 24.3% and 36.6% (for gefitinib) and 10.9% and 31.0% (for vinorelbine), respectively. In the 54 patients who were EGFR FISH-positive, HRs were 3.13 (95% CI, 1.45 to 6.76) for PFS and 2.88 (95% CI, 1.21 to 6.83) for OS. There were fewer treatment-related grade 3 to 5 adverse events with gefitinib (12.8%) than with vinorelbine (41.7%).ConclusionThere was no statistical difference between gefitinib and vinorelbine in efficacy in chemotherapy naive, unselected elderly patients with advanced NSCLC, but there was better tolerability with gefitinib. Individuals who were EGFR FISH-positive benefited more from vinorelbine than from gefitinib; this unexpected finding requires further study.