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Noted This Week

May 13–19

Federal agencies, Congress, and others need to improve representation of minority groups and underrepresented populations in clinical trials and research, according to a report from the National Academies of Sciences, Engineering, and Medicine (NASEM 2022 May 17 [Epub ahead of print]). Lack of representation may limit access to medical interventions and new therapies for some patients and increase health disparities, which could cost the United States hundreds of billions of dollars over the next 30 years. Among the report’s recommendations: require study sponsors to ensure that trial cohorts reflect the demographics of the condition under study, establish a task force to investigate new incentives for drug and device trials for which enrollment reflects the general population, and press the NIH to consider participant representation when assessing the impact of a grant proposal.

The FDA has placed a partial clinical hold on a phase I study of FHD-286 (Foghorn Therapeutics) for patients with relapsed/refractory acute myelogenous leukemia and myelodysplastic syndrome following the death of a patient with potential differentiation syndrome. Patients currently enrolled in the study and benefiting from the BRG1 and BRM inhibitor may continue to receive it, but no new patients can be enrolled until the hold is lifted; the hold does not apply to patients with metastatic uveal melanoma in a separate phase I trial.

According to the American Cancer Society, Medicaid expansion under the Affordable Care Act is associated with a 2-year increase in overall survival (OS) in patients newly diagnosed with cancer, especially among non-Hispanic Black people and people living in rural areas (J Natl Cancer Inst 2022 May 18 [Epub ahead of print]). Researchers analyzed data of over 2.5 million patients ages 18–62 in cancer registries from 42 states diagnosed with cancer before and after Medicaid expansion. OS increased from 80.58% to 82.23% in states that expanded Medicaid coverage and from 78.71% to 80.04% in those that didn’t—an increase of 0.44% in expansion states after adjusting for sociodemographic factors.

Researchers found that children with certain liver tumors have better outcomes when they underwent transplantation rather than having chemotherapy and surgery alone (J Hepatol 2022 May 13 [Epub ahead of print]). Researchers observed that some aggressive tumors have histologic features unlike hepatoblastomas or hepatocellular carcinomas, as well as molecular profiles that don’t fit into a single disease category, but both. The team found that these tumors tended to be more resistant to standard chemotherapy and have poor outcomes when not treated with more aggressive surgical approaches, including transplantation, indicating the need for molecular testing to guide treatment.

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