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Oncology News Central (ONC)
An FDA expert panel voted 16-0, with one abstention, recommending that future FDA approvals of PI3K inhibitors be supported by randomized data. The four currently-approved PI3K inhibitors for treating hematologic malignancies received FDA approval based on single-arm data. Although these drugs have offered durable ORR and improvements in PFS, randomized data presented at the hearing showed they are associated with higher rates of serious adverse events, including fatality.
Hematology/Oncology April 26th 2022
Blood
In an integrated analysis of mutations and clinical outcomes, comprising 2,200 patients with TP53-mutated myelodysplastic syndrome (MDS) with excess blasts (EB) or TP53-mutated acute myeloid leukemia (AML), the authors state that mutant TP53 AML and MDS-EB “do not differ with respect to molecular characteristics and survival” and argue these entities should be considered a single molecular disease entity. In a commentary to the above paper, TP53 and the star-crossed lovers MDS and AML, John Welch, MD, PhD of Washington University School of Medicine writes, “As a junior Hematology/Oncology fellow, I was told there were two types of physicians: splitters and mergers. That is, clinicians either seek to diagnose increasingly homogenously narrow groups of patients based on increasingly refined, shared characteristics, or they seek to find broad, overarching patterns that unite diagnostic classifications. Hematologic malignancies have been fertile ground for the diagnostic splitters of the world. On the other hand, there have been some noteworthy exceptions. Sometimes it is a technological advance that allows for the synthesis of disparate diagnoses.”
Hematology April 19th 2022
This international consortium of oncologists and researcher describe the advantages and limitations of both conventional chromosome banding and novel sequencing technologies. They state, “While one single test may not replace the totality of tests that currently exist, the active exploration and adoption of novel approaches in defined clinical settings may indeed allow for a continued and controlled evolution resulting in the successful clinical implementation of whole genome sequencing in the near future.”
Hematology/Oncology April 19th 2022
Blood Advances
This meta-analysis examined 1,212 published articles and abstracts, of which the 30 fulfilling their criteria were analyzed to evaluate the effect of vitamin D levels on OS, PFS, and secondarily on time to treatment, relapse rate, and non-relapse mortality in patients with hematologic malignancies. Lower vitamin D level at diagnosis was related to a significantly impaired prognosis for myeloid and lymphoid malignancies, as previously reported.
Hematology/Oncology March 22nd 2022