Phase II clinical trial of pazopanib in patients with acute myeloid leukemia (AML), relapsed or refractory or at initial diagnosis without an intensive treatment option (PazoAML)
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
Abstract
We evaluated pazopanib (800 mg orally QD) in patients not eligible for intensive treatment with relapsed/refractory AML or at initial diagnosis. Patients receiving pazopanib for > 14 days were analyzed for safety, tolerability, and efficacy. Co-primary endpoints were cumulative response rate and reduction of bone marrow microvessel density. Twenty patients (median age 76 years, range 52-86) were treated. Fifteen had relapsed/refractory and five had newly diagnosed AML. Median ECOG performance status was 1 (range 1-3). Four patients had adverse, 15 intermediate, and 1 patient favorable cytogenetic/molecular risk (ELN 2010 criteria). The safety profile of pazopanib was as reported. The most common adverse events of any grade were gastrointestinal. Two patients achieved PR (blast reduction > 50%), 14 stable disease (SD), and 4 progressive disease. Median PFS was 65 days (95% CI 29-105). After the end of the study, 1 CRi and 1 CRp occurred on demethylating agents, and 1 CR upon alloSCT. In these patients, SD and improved general condition on pazopanib allowed therapy escalation. Median OS for the overall study population was 191 days (95% CI 87-435) and 1-year survival was 35%. There was no significant change in microvessel density. Clinical trial information: NCT01361334.
Details
Original language | English |
---|---|
Pages (from-to) | 1393-1401 |
Number of pages | 9 |
Journal | Annals of hematology |
Volume | 98 |
Issue number | 6 |
Publication status | Published - Jun 2019 |
Peer-reviewed | Yes |
External IDs
Scopus | 85064055378 |
---|---|
ORCID | /0009-0007-3869-8765/work/160048692 |
Keywords
Keywords
- Aged, Aged, 80 and over, Angiogenesis Inhibitors/adverse effects, Antineoplastic Agents/adverse effects, Bone Marrow/blood supply, Female, Gastrointestinal Diseases/chemically induced, Humans, Indazoles, Kaplan-Meier Estimate, Leukemia, Myeloid, Acute/drug therapy, Male, Microvessels/drug effects, Middle Aged, Progression-Free Survival, Protein Kinase Inhibitors/adverse effects, Pyrimidines/adverse effects, Recurrence, Salvage Therapy, Sulfonamides/adverse effects, Treatment Outcome, Tumor Microenvironment/drug effects