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ASCO GI 2022 | Clinical trials versus the real world

Rutika Mehta, MD, MPH, Moffit Cancer Center, Tampa, FL, discusses clinical trials in comparison to real-world data. Dr. Mehta explains how clinical trials are an ideal setting with procedures enforced to ensure patients are enrolled properly depending on biomarker testing, however, the real-world is not so direct. For instance, a major barrier for many patients commencing therapy is the lack of tissue for biomarker testing, which are all immunohistochemically-based, especially due to the progress currently being made within the field of novel targeted therapies. Recently, it has become evident that patients with advanced gastroesophageal cancers who are MSI-high/deficient mismatch repair (dMMR) should be separated from the rest of patients within this patients population cancer due to the definite effectiveness of immune checkpoint inhibitors observed in this patient population in several clinical trials. Until now, biomarker testing, such as CTLA-4 and PD-L1, for this patient population has been relatively common only for advanced cancer patients. However, now it is becoming apparent that it is imperative that such biomarkers are tested on locally advanced patients in the neoadjuvant setting. This interview took place at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.