Elderly Patients Underrepresented in Studies Evaluating Hematologic Malignancies

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Patients over the age of 65 years are the most frequently diagnosed group with hematologic cancers, yet these patients are typically under-enrolled in clinical studies evaluating novel therapies.
Patients over the age of 65 years are the most frequently diagnosed group with hematologic cancers, yet these patients are typically under-enrolled in clinical studies evaluating novel therapies.
The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

Patients aged 75 years and older are underrepresented in hematologic malignancy studies in the United States, according to an oral presentation at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1

Patients over the age of 65 years are the most frequently diagnosed group with hematologic cancers, yet these patients are typically under-enrolled in clinical studies evaluating novel therapies.

For this retrospective analysis, researchers assessed Surveillance, Epidemiology, and End Results (SEER) program data submitted to the US Food and Drug Administration (FDA) from 2005 to 2015 for 44,144 patients who enrolled into clinical trials studying hematologic malignancies. Patient data were stratified according to hematologic disease type and were analyzed by age distributions of younger than 65, 65 to 74 years old, and 75 years and older.

Forty-five percent of patients were enrolled in lymphoma trials, 24% in chronic myeloid leukemia (CML), 22% in multiple myeloma (MM), 19% in chronic lymphocytic leukemia (CLL), 2% in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), and 6% in “other.” Acute lymphoblastic leukemia (ALL) trials enrolled less than 1% of study patients.

More than 50% of patients (except those in CLL and AML/myeloproliferative dysplasia studies), and more than 85% of patients in ALL trials were younger than 65 years old.

Clinical trials studying CLL, CML, and MM enrolled a disproportionately greater number of patients under the age of 65 compared with rest of the US cancer population.

Patients aged 75 years and older were "consistently underrepresented" in lymphoma, CLL, CML, and MM trials compared with the SEER cases seen in the same age group. The largest disparity was observed in patients enrolled in CML trials, where just 3.8% of patients were at least 75 years old vs 28.6% noted in SEER data.

The authors concluded that “[a]dditional strategies to increase clinical trial participation may be needed to enhance the quantity and quality of information needed to treat adults [of at least] 75 years of age and provide an appropriate benefit-risk profile in the population that is likely to receive treatment.”

Read more of Cancer Therapy Advisor's coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.

Reference

  1. Kanapuru B, Singh H, Myers A, et al. Enrollment of older adults in clinical trials evaluating patients with hematologic malignancies – the Food and Drug Administration (FDA) experience. Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA

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