Brief Report: Post Hoc Validation of Platinum Ineligibility in NSCLC From the Phase III IPSOS Study.

As no established consensus criteria for platinum ineligibility exist for NSCLC, we performed a post hoc analysis from IPSOS to evaluate clinical outcomes in a selected platinum-ineligible (sPI) population meeting a refined definition.

由于对于非小细胞肺癌（NSCLC）无法接受铂类治疗尚无既定的共识标准，我们对IPSOS进行了事后分析，以评估符合精炼定义的选定无法接受铂类治疗（sPI）人群的临床结果。

Methods

Patients with stage IIIB or IV NSCLC who were ineligible for platinum-doublet chemotherapy were randomized (2:1) to receive atezolizumab or single-agent chemotherapy (vinorelbine or gemcitabine).

被诊断为IIIB期或IV期非小细胞肺癌且不适合接受铂类双药化疗的患者被随机分配（2:1）接受阿替利珠单抗治疗或单药化疗（长春瑞滨或吉西他滨）。

Patients in the sPI subgroup were defined as those with Eastern Cooperative Oncology Group performance status of 3, age older than 80 years, Eastern Cooperative Oncology Group performance status of 2 with relevant comorbidities, or age 70 years or older with relevant comorbidities.

sPI亚组的患者被定义为那些东部肿瘤协作组表现状态评分为3，年龄超过80岁，东部肿瘤协作组表现状态评分为2且伴有相关合并症，或年龄在70岁或以上且伴有相关合并症的患者。

Results

Of 453 patients from the IPSOS intention-to-treatpopulation, 405 (89%) met sPI criteria.

在IPSOS意向治疗人群中，453名患者中有405名（89%）符合sPI标准。

Compared with chemotherapy, atezolizumab improved overall survival(unstratified hazard ratio0.78; 95% confidence interval: 0.63-0.98).

与化疗相比，阿替利珠单抗改善了总生存期（未分层风险比为0.78；95%置信区间：0.63-0.98）。

Atezolizumab was associated with fewer grade 3 or 4 treatment-related adverse events (46 of 266 [17.3%] versus 46 of 134 [34.3%] with chemotherapy), grade 5 treatment-related adverse events (two of 266 [0.8%] versus four of 134 [3.0%]), and stabilization or improvement of patient-reported health-related quality of life.

与化疗相比，Atezolizumab相关的3级或4级治疗相关不良事件较少（266例中有46例[17.3%]，而化疗组134例中有46例[34.3%]），5级治疗相关不良事件也较少（266例中有2例[0.8%]，而化疗组134例中有4例[3.0%]），并且患者报告的健康相关生活质量稳定或有所改善。

Conclusions

This subanalysis suggests that first-line treatment with atezolizumab provides long-term overall survival, consistent with the results from the intention-to-treatpopulation, and a favorable safety profile compared with single-agent chemotherapy in the sPI population.

这项亚组分析表明，一线使用Atezolizumab治疗可提供长期总生存期，与意向治疗人群的结果一致，并且与sPI人群中的单药化疗相比，具有良好的安全性。

In addition, the selection criteria for platinum ineligibility from the sPI population may provide a structured approach for treatment selection in NSCLC in clinical practice.

此外，从sPI人群中的铂类药物不适用选择标准可能为非小细胞肺癌（NSCLC）的临床治疗选择提供了一种结构化的方法。