التفاصيل البيبلوغرافية
| العنوان: |
SWOG0919: a Phase 2 study of idarubicin and cytarabine in combination with pravastatin for relapsed acute myeloid leukaemia. |
| المؤلفون: |
Advani, Anjali S., McDonough, Shannon, Copelan, Edward, Willman, Cheryl, Mulford, Deborah A., List, Alan F., Sekeres, Mikkael A., Othus, Megan, Appelbaum, Frederick R. |
| المصدر: |
British Journal of Haematology; Oct2014, Vol. 167 Issue 2, p233-237, 5p |
| مصطلحات موضوعية: |
ACUTE myeloid leukemia treatment, IDARUBICIN, CYTARABINE, PRAVASTATIN, CANCER relapse, COMBINATION drug therapy, CLINICAL trials, THERAPEUTICS, CANCER treatment |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
