法国贝桑松大学医疗中心Virginie Westeel在2025年欧洲肺癌大会（ELCC）上报告了加拿大癌症试验组（CCTG）BR.31 III期研究中度伐利尤单抗vs.安慰剂用于已切除IB-IIIA期非小细胞肺癌（NSCLC）的复发部位和后续治疗结果（摘要LBA3）。BR.31研究纳入了接受手术切除的IB期（肿瘤直径≥4 cm）、II期或IIIA期NSCLC患者，辅助化疗治疗后按2:1比例随机分配至度伐利尤单抗或安慰剂组（每4周一次，共12个月）。既往报道的结果显示，辅助度伐利尤单抗在EGFR-/ALK-NSCLC患者中未能改善无病生存期（DFS），无论PD-L1状态如何（主要研究人群：HR=0.93[0.71-1.25]，p=0.64）。

 

Dr.Westeel：我在2025 ELCC汇报了由十个国际学术组织共同开展的BR.31试验结果。BR.31研究比较了完全切除的IB-IIIA期非小细胞肺癌患者接受一年度伐利尤单抗辅助治疗与安慰剂的疗效。试验主要结果已在去年ESMO大会上公布，而我此次展示的是疾病复发率、第二原发癌发生率及后续治疗情况。需要说明的是，去年ESMO公布的BR.31试验无病生存期（DFS）数据显示，无论PD-L1表达如何，两组间DFS均无差异。

 

研究设计

 

我在2025 ELCC汇报的BR.31试验结果表明：两个治疗组在复发率方面无差异，第二原发癌的发生率也无差异。两组均有约40%的患者出现复发，5%-8%的患者出现第二原发癌（辅助度伐利尤单抗未能降低复发率或改变复发模式）。

 

EGFR-/ALK-NSCLC患者的疾病复发和第二原发癌发生率

 

在后续治疗方面，我们观察到了预期中的差异——安慰剂组复发患者接受免疫治疗的比例更高，这非常合理。

 

EGFR-/ALK-NSCLC患者远处（±局部区域）复发后首次后续治疗

 

Dr.Westeel:I just presented the results of the BR.31 trial that was conducted by ten international academic groups.It compared adjuvant durvalumab for one year to placebo in patients with completely resected stage IB-IIIA NSCLC.The primary results of this trial were presented at ESMO last year.What I have presented is the incidence of relapses of primary cancers and subsequent treatments.Just to remind you，last year when we presented at ESMO，the disease-free survival was presented and there was no difference between both arms in terms of disease-free survival regardless of PD-L1.What I presented today is that there was no difference in terms of incidence of recurrences，and there was no difference either in terms of the incidence of second primaries.Recurrences were diagnosed in around 40%of patients in both arms，and the second primary cancers between 5%and 8%of patients.In terms of treatment，there was a difference which was anticipated.Patients who were in the placebo arm who had a recurrence were more often treated with immunotherapy.That makes sense.

 

参考文献1.Westeel V，et al.Sites of relapse and subsequent therapy in the BR.31 phase III study of durvalumab vs placebo in resected stage IB-IIIA NSCLC.2025 ELCC，LBA3.

 

《肿瘤瞭望》在ELCC现场报道