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Rebecca Olin, MD, MS


Pilot Study of Vincristine Sulfate Liposome Injection in Resistant AML

By: Jenna Carter, PhD
Posted: Tuesday, May 11, 2021

Patients with relapsed or refractory acute myeloid leukemia (AML) often show resistance to therapy, showing poor outcomes. An article published in the Journal of Hematology highlighted the findings of a phase II study examining a drug that offers a more palliative approach with reportedly acceptable toxicity. Timothy S. Pardee, MD, PhD, of Wake Forest University, Winston-Salem, North Carolina, and colleagues examined the clinical effect of vincristine sulfate liposome injection (VSLI) in patients with AML; however, despite previous findings, this study revealed no effective responses.

A total of five patients with relapsed or refractory disease were treated using the U.S. Food and Drug Administration–approved dose and schedule for VSLI. The following parameters were examined for each patient: hematologic improvement rate of VSLI, response rate (complete remission or complete remission with incomplete blood cell count recovery), morphologic leukemia-free state, and overall survival.

Their findings revealed that no responses were achieved with VSLI. Their results may have occurred due to study limitations, given low enrollment, brief exposure to the drug, or poor efficacy of liposomal vincristine in this population. Two of the five patients discontinued therapy before the first response assessment during or shortly after cycle 1, as they had significant complications during treatment. Additionally, two patients were classified as nonresponders, as they both had increasing blast counts. Two patients also had peripheral neuropathy, which was unexpected given the low incidence of neuropathy in previous trials.

Dr. Pardee and colleagues concluded that, given the lack of effects and toxicity reports, it was best to discontinue the study and follow up with further studies to clarify the resistance mechanism to VSLI in this population.

Disclosure: The authors reported no conflicts of interest.

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