All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.
The aml Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the aml Hub cannot guarantee the accuracy of translated content. The aml and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View AML content recommended for you
Pravastatin in combination with idarubicin and cytarabine for R/R AML patients
Anjali S. Advani from Taussig Cancer Institute, Cleveland, OH, and colleagues conducted a phase II trial (NCT00840177), investigating the efficacy of high dose pravastatin, a cholesterol lowering agent, in combination with idarubicin and cytarabine in Relapsed/Refractory (R/R) AML patients with poor risk cytogenetics and poor risk molecular mutations. The results of the study were published on 25 January 2018 in Leukemia Research.
In this study, a total of 46 R/R AML patients (median age = 57 years [range 23 – 75]) who were in Complete Remission (CR) or CR with incomplete bone marrow recovery (CR/CRi) following the most recent chemotherapy < 6 months were enrolled and treated at SWOG institutions between April 2013 – November 2014. Patients were administered pravastatin (1280 mg orally) on Days 1–8, idarubicin (12 mg/m2/day) on Days 4–6, and cytarabine (1.5 g/m2/day) on Days 4–7. For this study to be considered sufficiently efficient, ≥ 12 patients should achieve CR/CRi of the first 37 patients accrued.
Key findings:
- CR/CRi rate: 30%
- Median Overall Survival (OS): 4.1 months
- Eleven patients proceeded to allogeneic Hematopoietic Stem Cell Transplant (HSCT)
- Median OS for patients proceeding to allogeneic HSCT: 27.1 months
- Median relapse free survival = 2.6 months (range 0.5 – 12.8 months)
- The most common Grade 3–5 non-hematologic AEs were febrile neutropenia (n = 31), bacteremia (n = 11), lung infection (n = 8), diarrhea (n = 9)
In this study, the CR/CRi rate in poor-risk R/R AML patients did not fulfil all the criteria for a positive study (P = 0.062) but the authors noted that the results of the study are still encouraging especially in a R/R AML population. They further added that “targeting the cholesterol pathway may have therapeutic impact” and thus further studies are required.
Key limitations highlighted by the authors include the small sample size and “uncontrolled structure” of the study. Thus they suggested that a randomized phase II study with chemotherapy versus chemotherapy plus pravastatin is required.
References