Interpreting Real-World Evidence in Large B-Cell Lymphoma

Dr. Perales discusses how clinicians should interpret real-world evidence alongside pivotal clinical trial data in large B-cell lymphoma. He emphasizes that RWE has largely validated clinical trial outcomes while demonstrating that many patients treated in routine practice, including those with thrombocytopenia or less-than-ideal performance status, may benefit from CAR T-cell therapy despite not meeting original trial eligibility criteria. He also highlights differences in toxicity assessment across earlier CAR T-cell studies and the importance of standardized criteria for evaluating cytokine release syndrome and ICANS when comparing safety outcomes. Dr. Perales explains that although RWE can be affected by retrospective design, reporting limitations, selection bias, and other sources of confounding, larger registries and multicenter datasets can help address these limitations through patient matching and broader populations. The discussion also highlights how RWE can answer clinical questions that pivotal trials were not designed to address, including outcomes among patients who achieve a complete response before CAR T-cell infusion.