Although clinical trials are the driving force behind most oncology-related discoveries and FDA approvals, strict eligibility criteria restrict many patients from participating, potentially leaving out large groups of people according to MD Ajai Chari. Real-world data become absolutely valuable in these situations in determining the efficacy of certain drug regimens.
In myeloma settings, the patients tend to be older with more onerous comorbidities, which often exclude much patient participation.
Recent research presented at the 2019 European Hematology Association Congress examined the real-world outcomes of patients with relapsed/refractory myeloma treated with lenalidomide, bortezomib plus dexamethasone (BD).
During the study, the RVP triplet improved progression-free survival (PFS) by an average of 26 months. Patients who may have also been considered frail, including those who were over the age of 80, or had a Charleston Comorbidity Index (CCI) and ECOG scores over 2 also saw a similar benefit.
Dr. Ajai Chari from the Icahn School of Medicine at Mount Sinai noted: “Often these 3 groups of patients are not included in studies, so you really don’t know what the data are.” For example, she noted, “How many 80 -plus-year-old elders are included in clinical trials? Almost none,” and he continued “So its good to see that this triplet therapy in the real world also still contributed to improved clinical outcomes.” He did mention that is was important for clinicians to scale back dosing of the drugs, when appropriate.
Pay Attention to Real-World Data
Looking ahead Chari emphasizes that it is crucial for researchers and clinicians alike to pay attention to real-world data noted Chari. It is critical in the myeloma setting! On that he noted, “In general, we’re learning more and more that clinical trials are really important to get drugs approved, but we really do need to balance that with real-world evidence, recognizing the disparities between the 2” he noted. Moreover “we really need to broaden (clinical trial selection criteria), particularly in myeloma and older patient.” He noted that these patients will have other cancers and ailments and we introduce more risk if we don’t involve them in studies.