Wakayama Medical University, Wakayama, Japan.
National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Lung Cancer. 2021 Jan;151:20-24. doi: 10.1016/j.lungcan.2020.11.020. Epub 2020 Nov 20.
The JO25567 randomized Phase II study demonstrated a statistically significant progression-free survival (PFS) benefit with erlotinib plus bevacizumab compared with erlotinib monotherapy in chemotherapy-naïve Japanese patients with epidermal growth factor receptor mutation-positive (EGFR+) non-small-cell lung cancer (NSCLC). Here we present updated PFS and final overall survival (OS) data after a median follow-up of 34.7 months.
Patients with stage IIIB/IV or postoperative recurrent NSCLC were randomized to receive oral erlotinib 150 mg once daily (n = 77) or erlotinib in combination with intravenous bevacizumab 15 mg/kg every 21 days (n = 75) until disease progression or unacceptable toxicity. OS was analyzed using an unstratified Cox proportional hazards model.
Consistent with the primary analysis, addition of bevacizumab to erlotinib was associated with a significant improvement in PFS (hazard ratio [HR] 0.52; 95 % confidence interval [CI]: 0.35-0.76; log-rank two-sided P = 0.0005; median 16.4 months vs 9.8 months, respectively). In contrast, a significant improvement in OS was not seen (HR 0.81; 95 % CI, 0.53-1.23; P = 0.3267; median 47.0 months vs 47.4 months, respectively). Post-study therapy was similar between the treatment arms and EGFR mutation type did not affect OS outcomes. The 5-year OS rate was numerically higher with erlotinib plus bevacizumab vs erlotinib monotherapy (41 % vs 35 %). Updated safety analyses confirmed the previously reported manageable tolerability profile, with no new safety issues.
Addition of bevacizumab to first-line erlotinib did not show significant improvement in OS in Japanese patients with stage IIIB/IV or postoperative recurrent EGFR+ NSCLC. Both treatment arms showed a similar median OS benefit (as long as 4 years), irrespective of individual patient characteristics. Results from ongoing studies evaluating the combination of EGFR and VEGF signaling inhibitors are eagerly awaited.
JapicCTI-111390 and JapicCTI-142569.
JO25567 随机 II 期研究表明，与厄洛替尼单药治疗相比，厄洛替尼联合贝伐珠单抗可显著改善化疗初治的表皮生长因子受体突变阳性（EGFR+）非小细胞肺癌（NSCLC）日本患者的无进展生存期（PFS）。在此，我们在中位随访 34.7 个月后报告了更新的 PFS 和最终总生存期（OS）数据。
IIIb/IV 期或术后复发的 NSCLC 患者被随机分为每日口服厄洛替尼 150mg（n=77）或厄洛替尼联合贝伐珠单抗 15mg/kg 静脉输注每 21 天（n=75），直至疾病进展或不可接受的毒性。使用非分层 Cox 比例风险模型分析 OS。
与主要分析一致，贝伐珠单抗联合厄洛替尼可显著改善 PFS（风险比 [HR] 0.52；95%置信区间 [CI]：0.35-0.76；双侧对数秩检验 P=0.0005；中位 16.4 个月 vs 9.8 个月）。然而，OS 并未显著改善（HR 0.81；95%CI，0.53-1.23；P=0.3267；中位 47.0 个月 vs 47.4 个月）。治疗后治疗方案在治疗组之间相似，EGFR 突变类型对 OS 结果没有影响。厄洛替尼联合贝伐珠单抗组的 5 年 OS 率高于厄洛替尼单药组（41% vs 35%）。更新的安全性分析证实了之前报道的可管理的耐受性，没有新的安全性问题。
在 IIIb/IV 期或术后复发的 EGFR+ NSCLC 日本患者中，贝伐珠单抗联合一线厄洛替尼治疗并未显著改善 OS。两个治疗组均表现出相似的中位 OS 获益（长达 4 年），与个体患者特征无关。正在进行的评估 EGFR 和 VEGF 信号抑制剂联合治疗的研究结果令人期待。
JapicCTI-111390 和 JapicCTI-142569。
