奥希替尼联合贝伐单抗对比奥希替尼治疗未经治的EGFR突变

SCI

2 June 2022

Randomized phase II study of osimertinib plus bevacizumab versus osimertinib for untreated patients with non-squamous non-small cell lung cancer harboring EGFR mutations; WJOG9717L study

（J Thorac Oncol；IF:14.138）

• Kenmotsu H, Wakuda K, Mori K, et al. Randomized phase II study of osimertinib plus bevacizumab versus osimertinib for untreated patients with non-squamous non-small cell lung cancer harboring EGFR mutations; WJOG9717L study [published online ahead of print, 2022 May 27]. J Thorac Oncol. 2022

Purpose 目的

To evaluate the efficacy and safety of osimertinib plus bevacizumab for previously untreated patients with advanced non-squamous NSCLC harboring EGFR sensitizing mutations.

评估奥希替尼联合贝伐单抗治疗未经治的EGFR 敏感突变的晚期非鳞癌的非小细胞肺癌（NSCLC）患者的疗效和安全性。

Patients and methods 患者和方法

We conducted a randomized, open-label, phase II study at 21 institutions in Japan. Previously untreated patients with advanced non-squamous NSCLC harboring EGFR sensitizing mutations received either osimertinib (80 mg, daily) plus bevacizumab (15 mg/kg, every 3 weeks) or osimertinib monotherapy, and were stratified according to sex, stage and EGFR mutation status. The primary endpoint was progression-free survival (PFS) in the intention to treat population, assessed by means of blinded, independent central radiologic review.

我们在日本的21家机构进行了一项随机、开放标签的II期研究。未经治疗的EGFR敏感突变的晚期非鳞癌的NSCLC 患者接受奥希替尼（80 mg，每天）加贝伐单抗（15 mg/kg，每3周）或奥希替尼单药治疗，并根据性别、分期和EGFR突变状态进行分层。主要终点是意向性治疗人群中的无进展生存期（PFS），通过盲态独立中心阅片进行评估。

Results 结果

Between January 2018 and September 2018, 122 patients were enrolled (osimertinib plus bevacizumab arm, 61 patients; osimertinib monotherapy arm, 61 patients). At a median follow-up duration of 19.8 months, the median PFS was 22.1 months for osimertinib plus bevacizumab and 20.2 months for Osimertinib monotherapy, with a hazard ratio of 0.862 (60% confidence interval, 0.700-1.060; 95% confidence interval, 0.531-1.397; one-sided stratified log-rank p=0.213). Adverse events of grade 3 or worse were observed in 34 patients (56%) in the osimertinib plus bevacizumab arm and 29 (48%) in the osimertinib monotherapy arm. In addition, 2 (3%) and 11 (18%) patients experienced any grade pneumonitis, respectively, and grade 3 pneumonitis was observed in 1 patient (2%) in each arm.

2018年1月至2018年9月期间，共122 名患者入组（奥希替尼加贝伐单抗组，61 名患者；奥希替尼单药治疗组，61 名患者）。中位随访时间为19.8个月。奥希替尼加贝伐单抗的中位PFS为22.1个月，奥希替尼单药治疗为20.2个月，风险比为0.862（60%置信区间，0.700-1.060；95% 置信区间，0.531 -1.397；单侧分层对数秩p=0.213）。奥希替尼联合贝伐单抗组的34名患者（56%）和奥希替尼单药治疗组的 29 名患者（48%）观察到 3 级或更严重的不良事件。此外，两组中分别有2名 (3%) 和11名 (18%) 患者出现任意级别的肺炎，每组分别有1名患者（2%）观察到3级肺炎。

Conclusions 结论

This study failed to show the efficacy of osimertinib plus bevacizumab for improving the PFS among patients with non-squamous NSCLC harboring EGFR mutations as first-line treatment.

本研究未能显示奥希替尼联合贝伐单抗作为一线治疗改善EGFR突变的非鳞癌的NSCLC患者在PFS上的疗效。