Real‐World Outcomes of Patients with Metastatic Non‐Small Cell Lung Cancer Treated with Programmed Cell Death Protein 1 Inhibitors in the Year Following U.S. Regulatory Approval. (27th December 2018)

• Record Type: Journal Article
• Authors: Khozin, Sean; Carson, Kenneth R.; Zhi, Jizu; Tucker, Melisa; Lee, Shannon E.; Light, David E.; Curtis, Melissa D.; Bralic, Marta; Kaganman, Irene; Gossai, Anala; Hofmeister, Philip; Torres, Aracelis Z.; Miksad, Rebecca A.; Blumenthal, Gideon Michael; Pazdur, Richard; Abernethy, Amy P.
• Is Part Of: Oncologist. Volume 24:Number 5(2019)
• Page Start: 648
• Page End: 656
• Publication Date: 2018-12-27
• Subjects: Non‐small cell lung cancer -- Real‐world evidence -- Electronic health records -- Overall survival -- Nivolumab -- Pembrolizumab; Oncology -- Periodicals; Tumors -- Periodicals; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Oncology; Tumors; Neoplasms; Electronic journals; Periodicals; Periodicals; 616.994
• DOI: 10.1634/theoncologist.2018-0307
• Languages: English
• ISSNs: 1083-7159

Abstract

Abstract: Background: Evidence from cancer clinical trials has strong internal validity but can be difficult to generalize to real‐world patient populations. Here we analyzed real‐world outcomes of patients with metastatic non‐small cell lung cancer (mNSCLC) treated with programmed cell death protein 1 (PD‐1) inhibitors in the first year following U.S. regulatory approval. Materials and Methods: This retrospective study leveraged electronic health record (EHR) data collected during routine patient care in community cancer care clinics. The cohort included patients with mNSCLC who had received nivolumab or pembrolizumab for metastatic disease ( n = 1, 344) with >1 EHR‐documented visit from January 1, 2011, to March 31, 2016. Patients with a > 90‐day gap between advanced disease diagnosis and first EHR structured data entry were excluded. Results: Estimated median overall survival (OS) was 8.0 months (95% confidence interval 7.4–9.0 months). Estimated median OS was 4.7 months (3.4–6.6) for patients with anaplastic lymphoma kinase rearrangement‐ and epidermal growth factor receptor mutation‐positive tumors, and 8.6 months (7.7–10.6) for patients without such mutations. Age at PD‐1 inhibitor initiation or line of therapy did not impact OS. Conclusion: This analysis suggests OS in real‐world patients may be shorter than in conventional clinical trial patient cohorts, potentially due to narrow trial eligibility criteria. The lack of difference in OS by line of therapy or age at immunotherapy initiation suggests sustained benefit of PD‐1 inhibitors in multitreated patients with mNSCLC and that age is not a predictor of outcome. Further studies are underway in patients with comorbidities, organ dysfunction, and multiple prior therapies. Abstract : This article reports on overall survival outcomes in a real‐world cohort of patients with metastatic non‐small cell lung cancer treated with PD‐1 inhibitors post‐approval. Understanding the differences between these real‐world data and those reported from clinical trials may provide insights on the generalizability of clinical trial data and optimize clinical treatment decisions in practice.