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SWOG 0919: a Phase 2 study of idarubicin and cytarabine in combination with pravastatin for relapsed acute myeloid leukaemia

Year: 2014
Type: article
Study design: Clinical Trial
Abstract: Inhibition of cholesterol synthesis and uptake sensitizes acute myeloid leukaemia (AML) blasts to chemotherapy. A Phase 1 study demonstrated the safety of high dose pravastatin given with idarubicin and cytarabine in patients with AML and also demonstrated an encouraging response rate. The Southwestern Oncology Group (SWOG) trial, SWOG S0919, was a Phase 2 trial evaluating the complete remission (CR) rate in a larger number of patients with relapsed AML treated with idarubicin, cytarabine and pravastatin. This study closed to accrual after meeting the defined criterion for a positive study. Thirty-six patients with a median age of 59 years (range 23-78) were enrolled. The median time from diagnosis to registration was 18 months. Relapse status was first relapse, 17 patients (47%); second relapse, 15 patients (42%); third relapse, two patients (5·5%) and fourth relapse, two patients (5·5%). The response rate was 75% [95% confidence interval: 58-88%; 20 CRs, 7 CR with incomplete count recovery (CRi)], and the median overall survival was 12 months. The P-value comparing 75-30% (the null response rate based on prior SWOG experience) was 3·356 × 10(-4) . Given the encouraging CR/CRi rate, this regimen should be considered for testing in a prospective randomized trial against best conventional therapy.
DOI: 10.1111/bjh.13035
Authors: Anjali S. Advani, Shannon McDonough, Edward Copelan, Cheryl Willman, Deborah A. Mulford, Alan F. List, Mikkael A. Sekeres, Megan Othus, Frederick R. Appelbaum
Institutions: Cleveland Clinic, Carolinas Healthcare System, Levine Cancer Institute, UNM Comprehensive Cancer Center, University of Rochester Medicine, University of Rochester, Moffitt Cancer Center, Fred Hutch Cancer Center
Language: English
Subfield: Hematology
Field: Medicine
Open Access status: green
Awards: G1257575315, G1545560008, G1548551769, G1790576020, G1794831901, G1938688226, G1958973285, G2064543036, G2201816905, G2237949143, G2419449687, G2435896781, G268786457, G2745671310, G2750730928, SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER, G3103693091, G3451735180, G3484997517, G3521018462, G36541222, G3737421695, SWOG Network Group Operations Center of the NCTN, G379387698, Southwest Oncology Group, G444114835, Southwest Oncology Group, G4967831794, G5264753430, G6109875642, G7484487955, G763325562, G8116866424, G8156375866, G8937348795
OpenAlex ID: W2132319954
FWCI: 1.836
Cites: 21
Cited by: 57
Related to: 10