Mohammad Jahanzeb, MD, professor of Clinical Medicine, Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, discusses the eligibility criteria for immunotherapy trials in non–small cell lung cancer.
Mohammad Jahanzeb, MD, professor of clinical medicine, Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, discusses the eligibility criteria for immunotherapy trials in non—small cell lung cancer (NSCLC).
There is a disconnect between patients enrolled in immunotherapy clinical trials versus the real-world setting in NSCLC, Jahanzeb notes. Due to the toxicity profile of immunotherapy, researchers are weary of upsetting an immune system that is fighting off other factors or comorbidities. Naturally, patients with autoimmune diseases or who have had organ or stem cell transplantation would be excluded from these studies.
Furthermore, certain subsets of lung cancer could have preexisting autoimmune mechanisms. If a patient has previously had pneumonitis and limited lung reserve, they would also likely miss enrollment criteria because they cannot afford to be in the 2% to 3% of patients who experience severe pneumonitis while on immunotherapy.
In terms of general criteria, researchers would avoid patients who have an additional invasive tumor besides NSCLC. Other exclusion factors include poor performance status, abnormal laboratory tests, and inadequate organ function. Jahanzeb concludes that these studies tend to have a bias against elderly patients, although a specific age is not put into the guidelines. Instead, these trials should consider physical age instead of numeric age.