A Pilot Phase II Study of the Feasibility and Efficacy of Vincristine Sulfate Liposome Injection in Patients With Relapsed or Refractory Acute Myeloid Leukemia.
Acute myeloid leukemia
Refractory
Relapsed
Therapy
Vincristine
Journal
Journal of hematology
ISSN: 1927-1220
Titre abrégé: J Hematol
Pays: Canada
ID NLM: 101635099
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
02
11
2020
accepted:
12
11
2020
entrez:
1
3
2021
pubmed:
2
3
2021
medline:
2
3
2021
Statut:
ppublish
Résumé
Resistance to therapy and a poor outcome characterize relapsed or refractory acute myeloid leukemia (AML). There is a clear need for additional palliative approaches with acceptable toxicities. Vincristine sulfate liposome injection (VSLI) confers enhanced pharmacokinetics and activity when compared to the parent compound. It is effective and well tolerated in heavily pretreated acute lymphoblastic leukemia (ALL) patients. Preclinically VSLI has activity in vincristine-resistant cancers. As relapsed or refractory AML patients would have minimal exposure to vincristine it was hypothesized that VSLI would be well tolerated and may have activity. A pilot phase II clinical trial was conducted. Five patients with relapsed or refractory disease were treated using the Food and Drug Administration (FDA)-approved dose and schedule. Of the five patients treated none completed more than one cycle; there were no responses and two patients did not complete one cycle of therapy. Surprisingly, three of the five patients had treatment-related constipation, and two had neuropathy consistent with the known toxicities of VSLI. Given the toxicity and lack of response, the trial was terminated early. VSLI had no activity against relapsed or refractory AML in this limited, single institution dataset.
Sections du résumé
BACKGROUND
BACKGROUND
Resistance to therapy and a poor outcome characterize relapsed or refractory acute myeloid leukemia (AML). There is a clear need for additional palliative approaches with acceptable toxicities. Vincristine sulfate liposome injection (VSLI) confers enhanced pharmacokinetics and activity when compared to the parent compound. It is effective and well tolerated in heavily pretreated acute lymphoblastic leukemia (ALL) patients. Preclinically VSLI has activity in vincristine-resistant cancers. As relapsed or refractory AML patients would have minimal exposure to vincristine it was hypothesized that VSLI would be well tolerated and may have activity.
METHODS
METHODS
A pilot phase II clinical trial was conducted. Five patients with relapsed or refractory disease were treated using the Food and Drug Administration (FDA)-approved dose and schedule.
RESULTS
RESULTS
Of the five patients treated none completed more than one cycle; there were no responses and two patients did not complete one cycle of therapy. Surprisingly, three of the five patients had treatment-related constipation, and two had neuropathy consistent with the known toxicities of VSLI. Given the toxicity and lack of response, the trial was terminated early.
CONCLUSIONS
CONCLUSIONS
VSLI had no activity against relapsed or refractory AML in this limited, single institution dataset.
Identifiants
pubmed: 33643502
doi: 10.14740/jh771
pmc: PMC7891907
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1-7Informations de copyright
Copyright 2021, Seegars et al.
Déclaration de conflit d'intérêts
The authors have no relevant conflicts of interest to disclose.
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