SOHO 2019: Are Real-World and Clinical Data Synchronized With Treatment of Resistant Myeloma?
Posted: Tuesday, October 1, 2019
Real-world evidence is a critical tool for understanding the impact of novel treatments for relapsed or refractory multiple myeloma, according to research presented at the 2019 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract EXABS-MM-441) in Houston. In addition, real-world data have often confirmed clinical findings regarding treatment and its impact on survival outcomes.
“Clinical trial and [real-world] data are complementary, and they should be considered as important feedback to improve both clinical trial designs and our clinical practice,” concluded Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens in Greece, and colleagues.
In the past, there have been discrepancies between clinical trial data and real-world patient outcomes. This can be attributed to differences in factors such as patient selection, treatment center expertise, and treatment cost. In addition, many clinical trials have an endpoint such as deep response, for example, when sustained disease control may be the real-world treatment goal.
Using a targeted literature review, an analysis revealed that real-world clinical data echo the general efficacy of novel treatments noted in studies, with some differences. For example, real-world data usually indicate a smaller range of median progression-free survival and time-to-next-treatment periods than clinical trials. Another example includes differences in the median duration of therapy.
Several specific novel agents have had their efficacy and/or safety findings confirmed by real-world data. As for proteasome inhibitors, bortezomib-based treatment was found to significantly improve survival outcomes in clinical trials, and carfilzomib-based treatment was found to have an overall response rate as high as 80%; both were consistent with real-world findings. Similarly, real-world data on immunomodulatory treatments such as lenalidomide and pomalidomide coincide with clinical trial data regarding overall response rates and expected safety profiles. Finally, the anti-CD38 monoclonal antibody daratumumab has also had its clinical trial efficacy mirrored in real-world data, specifically its ability to significantly increase overall and progression-free survival.
Disclosure: The study authors’ disclosure information can be found at soho2019.com.
