|The following article features coverage from the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO). Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Clinical trials that support approvals of therapies for hematologic malignancies are not representative of the real-world patient populations, according to a study presented in a poster at the Annual Meeting of the Society of Hematologic Oncology (SOHO).
Researchers found that the median age of participants in these trials was about 4 years younger than the real-world patient population, even though most trial protocols did not have age restrictions.
To conduct this study, researchers obtained median ages of trial participants from the prescribing information for therapies first approved by the US Food and Drug Administration (FDA) for an adult indication between 2015 and 2019. The real-world adult median age estimates were obtained from the Surveillance, Epidemiology, and End Results (SEER) database.
During the study period, 22 hematologic malignancy therapies were FDA-approved based on the results of 26 trials. The trials included 6,033 patients, 38% were phase 3, and 42% had a randomized, controlled design.
All of the trials had eligibility restrictions based on comorbidities, organ function, or hematopoietic function, and 42% had restrictions based on performance status. Most trials (92%) had no upper age limit.
However, the researchers noted that “poor performance status, comorbidities, or organ impairment likely contributed to older patients’ ineligibility.”
The median age of trial participants was 3.8 years younger than the median age of the real-world patient population (P <.01).
Age differences were greatest for trials of acute myeloid leukemia (-7.8 years difference in median age) and large B-cell lymphoma (-7.0 years), followed by myeloma (-4.4 years), mantle cell lymphoma (-2.7 years), and follicular lymphoma (-1 year).
“Adequate representation in clinical trials is critical to evaluate the safety and efficacy of new therapies in the patient population who will eventually receive them,” the researchers wrote. “Post-approval real-world research can help [us] understand the effect of these therapies on older adults.”
Disclosures: The study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Read more of Cancer Therapy Advisor’s coverage of SOHO 2021 by visiting the conference page.
Jeune-Smith Y, Zettler ME, Phillips EG, Feinberg BA, Gajira A. Age-based disparities in clinical trials supporting food and drug administration (FDA) approval of therapies for hematologic malignancies. Paper presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 8-11, 2021.