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06-04-2018 | Clinical trial | News

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medwireNews: In this month’s roundup, we cover topics including laboratory eligibility criteria as a potential barrier to clinical participation and the impact of cognitive dysfunction on survival in patients with hematologic cancers. Read on to find out more.

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Laboratory eligibility criteria could be preventing Black men from participating in clinical trials, Paul Nguyen (Harvard Medical School, Boston, Massachusetts, USA) and co-researchers report in JAMA Oncology.

Of 401 interventional prostate cancer trials, 25.2% used unadjusted serum creatinine levels alone to determine eligibility, even though Black patients tend to have higher values for any given functional status. And 41.4% required an absolute neutrophil count of at least 1.5x109 cells/L, thereby excluding participants with benign ethnic neutropenia, a condition that appears not to increase infection risk.

“While adopting race-based differences in trial criteria may add slight logistical challenges when ensuring that patients meet trial eligibility, these adjustments would prevent healthy individuals from being excluded solely because of benign laboratory differences caused by their race,” the team concludes.

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A US National Cancer Database analysis of 25,216 patients with nonmetastatic squamous cell carcinoma of the head and neck shows that an interval of 50 days or more between surgery and initiation of adjuvant radiotherapy is associated with worse median overall survival (OS) than an interval of 42 days or less, at 6.5 and 10.5 years, respectively, and an adjusted hazard ratio of 1.07.

As such, Jeremy Harris, from Stanford University in California, USA, and team emphasize the importance of avoiding unnecessary delays after surgery.

Writing in JAMA Otolaryngology–Head & Neck Surgery, they add: “Measures to intensify therapy including with accelerated fractionation should be considered when delays are unavoidable.”

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Lead author Gregory Abel (Dana-Farber Cancer Institute, Boston) and colleagues have found that specific domains of cognitive impairment could impact survival in patients with hematologic malignancies, highlighting the need for targeted interventions for this vulnerable population.

In a study – published in JAMA Oncology – of 360 patients with leukemia, myeloma, or lymphoma who completed cognitive screening tests, probable executive dysfunction was present in 35.3%, while 17.2% had probable impaired working memory.

And impairment in working memory, but not executive function, was associated with a significantly poorer OS, at a median of 10.9 months versus 12.2 months for those without such impairment.

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A pooled analysis of the phase I JAVELIN Solid Tumor and the phase II JAVELIN Merkel 200 trials confirms the tolerability of the anti-PD-L1 antibody avelumab.

Among 1738 patients with advanced solid tumors or previously treated metastatic Merkel cell carcinoma, grade 3 or worse treatment- and immune-related adverse events (AEs) occurred in a corresponding 10.2% and 2.2% of participants, and led to discontinuation in 6.2% and 2.0%, respectively.

As reported by Karen Kelly (University of California-Davis Comprehensive Cancer Center, Sacramento, USA) and co-authors in Cancer, four deaths were attributed to treatment-related AEs.

By Shreeya Nanda

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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