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

• Published in: British journal of haematology 2014-10, Vol.167 (2), p.233-237
• Main Authors: Advani, Anjali S., McDonough, Shannon, Copelan, Edward, Willman, Cheryl, Mulford, Deborah A., List, Alan F., Sekeres, Mikkael A., Othus, Megan, Appelbaum, Frederick R.
• Format: Article
• Language: English
• ISSN: 0007-1048; 1365-2141
• DOI: 10.1111/bjh.13035

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 CR s, 7 CR with incomplete count recovery ( CR i)], 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 / CR i rate, this regimen should be considered for testing in a prospective randomized trial against best conventional therapy.