26 June 2018

An international group of haematology experts have written a report on the progress made in blood cancer treatment, and specifically the issue of toxicity from treatment.

Dr Gita Thanarajasingam of the Mayo Clinic, Minnesota, USA, and colleagues in the Commission write in The Lancet Haematology yesterday (12 June) that: "Several haematological malignancies are now chronic diseases that are treated with continuously administered therapies that have unique side-effects over time."

Their report covers the assessment of adverse events in a range of malignancies, with the aim of improving toxicity assessment in clinical trials in haematological malignancies.

They believe that the current process of adverse event assessment needs rethinking, as it is too focused on assessing a drug or regimen's safety, often fails to identify important delayed, chronic or cumulative effects that can affect patients substantially.

Instead, they write, it must incorporate patient-reported outcomes, issues unique to stem-cell transplantation and survivorship, and challenges in regulatory approval.

They write: "We have identified a range of priority issues in these areas and defined potential solutions to challenges associated with adverse event assessment in the current treatment landscape of haematological malignancies."

The Commission is proposing recommendations to policy makers, researchers, industry and regulators. They launched these recommendations at the European Haematological Association meeting in Stockholm, Sweden, held 14 to 17 June.

Dr Thanarajasingam says: "Measures to address the broad facets of toxicity assessment must be prioritised and further developed to ultimately enhance accurate, comprehensive, patient-centred toxicity reporting that will meaningfully inform the care of patients with blood cancers."

Source: Thanarajasingam, G. et al. Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies. The Lancet Haematology 12 June 2018 doi: 10.1016/S2352-3026(18)30051-6

Link: http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30051-6/fulltext


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