Nagasaka Misako, Molife Cliff, Cui Zhanglin Lin, Stefaniak Victoria, Li Xiaohong, Kim Sangmi, Lee Hsui-Yung, Beyrer Julia, Blumenschein George
Division of Hematology & Oncology Department of Medicine, University of California Irvine, Orange County, CA 92868, USA.
Value, Evidence, & Outcomes, Eli Lilly & Company, Indianapolis, IN 46225, USA.
Future Oncol. 2022 May;18(16):1963-1977. doi: 10.2217/fon-2022-0099. Epub 2022 Mar 31.
This retrospective study estimated efficacy and safety of sintilimab + pemetrexed + platinum (SPP) versus placebo + pemetrexed + platinum (PPP) in untreated locally advanced/metastatic, nonsquamous non-small-cell lung cancer (NSCLC), after adjusting each ORIENT-11 trial patient's contribution to ORIENT-11 data based on characteristics of a target US population. The target US population (n = 557) was selected from a real-world deidentified advanced NSCLC database based on key ORIENT-11 eligibility criteria. Inverse probability weights for ORIENT-11 patients (n = 397) relative to US patients were calculated. Efficacy and safety of SPP versus PPP were adjusted by inverse probability weights. After adjustment, progression-free survival remained superior for SPP. Other efficacy and safety outcomes were consistent. These results provide evidence on how the effects observed with SPP in ORIENT-11 could translate to a US population with untreated locally advanced/metastatic nonsquamous NSCLC.
这项回顾性研究评估了信迪利单抗+培美曲塞+铂类（SPP）对比安慰剂+培美曲塞+铂类（PPP）用于未经治疗的局部晚期/转移性非鳞状非小细胞肺癌（NSCLC）的疗效和安全性，该评估是在根据美国目标人群的特征调整了每项ORIENT-11试验患者对ORIENT-11数据的贡献之后进行的。美国目标人群（n = 557）是根据ORIENT-11的关键纳入标准从一个真实世界的匿名晚期NSCLC数据库中选取的。计算了ORIENT-11患者（n = 397）相对于美国患者的逆概率权重。SPP对比PPP的疗效和安全性通过逆概率权重进行了调整。调整后，SPP的无进展生存期仍然更优。其他疗效和安全性结果一致。这些结果为ORIENT-11中观察到的SPP的疗效如何转化到未经治疗的局部晚期/转移性非鳞状NSCLC美国人群提供了证据。
