Introduction: Cancer immunotherapy may alter tumor biology such that treatment effects can extend beyond radiographic progression. In the randomized, phase III OAK study of atezolizumab (anti–programmed death‐ligand 1) versus docetaxel in advanced NSCLC, overall survival (OS) benefit with atezolizumab was observed in the overall patient population, without improvement in objective response rate (ORR) or progression‐free survival (PFS). We examine the benefit‐risk of atezolizumab treatment beyond progression (TBP). Methods: Eight hundred fifty patients included in the OAK primary efficacy analysis were evaluated. Atezolizumab was continued until loss of clinical benefit. Docetaxel was administered until Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) disease progression (PD)/unacceptable toxicity; no crossover to atezolizumab was allowed. ORR, PFS, post‐PD OS, target lesion change, and safety were evaluated. Results: In atezolizumab‐arm patients, ORR was 16% versus 14% and median PFS was 4.2 versus 2.8 months per immune‐modified RECIST versus RECIST v1.1. The median post‐PD OS was 12.7 months (95% confidence interval [CI]: 9.3–14.9) in 168 atezolizumab‐arm patients continuing TBP, 8.8 months (95% CI: 6.0–12.1) in 94 patients switching to nonprotocol therapy, and 2.2 months (95% CI: 1.9–3.4) in 70 patients receiving no further therapy. Of the atezolizumab TBP patients, 7% achieved a post‐progression response in target lesions and 49% had stable target lesions. Atezolizumab TBP was not associated with increased safety risks. Conclusions: Within the limitations of this retrospective analysis, the post‐PD efficacy and safety data from OAK are consistent with a positive benefit‐risk profile of atezolizumab TBP in patients performing well clinically at the time of PD.

中文翻译：

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Atezolizumab 治疗超越晚期非小细胞肺癌的进展：随机 III 期 OAK 研究的结果

简介：癌症免疫疗法可能会改变肿瘤生物学，因此治疗效果可以扩展到放射学进展之外。在晚期 NSCLC 中阿特珠单抗（抗程序性死亡配体 1）与多西他赛的随机 III 期 OAK 研究中，在总体患者人群中观察到阿特珠单抗的总生存期 (OS) 获益，而客观缓解率 (ORR) 没有改善或无进展生存期 (PFS)。我们研究了 atezolizumab 治疗超越进展 (TBP) 的获益风险。方法：评估了包含在 OAK 主要疗效分析中的 850 名患者。Atezolizumab 持续使用直至失去临床获益。多西紫杉醇一直使用到实体瘤反应评估标准 1.1 版 (RECIST v1.1) 疾病进展 (PD)/不可接受的毒性；不允许与atezolizumab交叉。评估 ORR、PFS、PD 后 OS、目标病变变化和安全性。结果：在 atezolizumab 组患者中，ORR 分别为 16% 和 14%，中位 PFS 分别为 4.2 和 2.8 个月，每个免疫修饰的 RECIST 与 RECIST v1.1。168 名继续 TBP 的阿特珠单抗组患者的 PD 后 OS 中位数为 12.7 个月（95% 置信区间 [CI]：9.3-14.9），94 名转为非方案治疗的患者为 8.8 个月（95% CI：6.0-12.1），和 2.2 个月（95% CI：1.9-3.4）在 70 名未接受进一步治疗的患者中。在 atezolizumab TBP 患者中，7% 的目标病灶达到了进展后反应，49% 的目标病灶稳定。Atezolizumab TBP 与增加的安全风险无关。结论：在本回顾性分析的局限性内，