Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.
Sean KhozinAmy P AbernethyNathan C NussbaumJizu ZhiMelissa D CurtisMelisa TuckerShannon E LeeDavid E LightAnala GossaiRachael A SorgAracelis Z TorresPayal PatelGideon Michael BlumenthalRichard PazdurPublished in: The oncologist (2018)
Evidence gathered in conventional clinical trials used to assess safety and efficacy of new therapies is not necessarily generalizable to real-world patients receiving these drugs following regulatory approval. Real-world evidence derived from electronic health record data can yield complementary evidence to enable optimal clinical decisions. Examined here is a cohort of programmed cell death protein 1 inhibitor-treated metastatic non-small cell lung cancer patients in the first year following regulatory approval of these therapies in this indication. The analysis revealed how the real-world cohort differed from the clinical trial cohorts, which will inform which patients are underrepresented and warrant additional studies.
Keyphrases
- clinical trial
- electronic health record
- end stage renal disease
- small cell lung cancer
- squamous cell carcinoma
- newly diagnosed
- single cell
- chronic kidney disease
- transcription factor
- ejection fraction
- clinical decision support
- drug administration
- phase ii
- cell therapy
- prognostic factors
- peritoneal dialysis
- adverse drug
- machine learning
- phase iii
- study protocol
- binding protein
- small molecule
- bone marrow
- protein protein
- deep learning
- artificial intelligence
- placebo controlled