A phase I/II study of sorafenib in combination with low dose cytarabine in elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome from the National Cancer Institute of Canada Clinical Trials Group: trial IND.186. Issue 4 (April 2013)

• Record Type: Journal Article
• Authors: Macdonald, David A.; Assouline, Sarit E.; Brandwein, Joseph; Kamel-Reid, Suzanne; Eisenhauer, Elizabeth A.; Couban, Stephen; Caplan, Stephen; Foo, Alison; Walsh, Wendy; Leber, Brian
• Is Part Of: Leukemia & lymphoma. Volume 54:Issue 4(2013:Apr.)
• Page Start: 760
• Page End: 766
• Publication Date: 2013-04
• Subjects: Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.3109/10428194.2012.737917
• Languages: English
• ISSNs: 1042-8194

Abstract

<abstract> <title>Abstract</title> <p>Sorafenib is active in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The National Cancer Institute of Canada (NCIC) Clinical Trials Group initiated a phase I/II study of the combination of sorafenib with cytarabine in older patients with AML or high-risk MDS who were unsuitable for intensive chemotherapy. <italic>FLT3</italic> mutational status was determined in all patients. Twenty-one patients were enrolled (four MDS, 17 AML) with a median age of 77 years. The recommended phase II dose (RP2D) was cytarabine 10 mg bid days 1–10 and sorafenib 600 mg/day days 2–28. Dose-limiting toxicities were fatigue, sepsis and skin rash. Of 15 evaluable patients treated at the RP2D, two patients responded. The overall response rate for eligible patients was 10%. <italic>FLT3</italic> mutations were found in only three patients. We conclude that this combination of sorafenib and cytarabine has limited activity in this unselected cohort of elderly patients with AML/MDS in which <italic>FLT3</italic> mutations seemed underrepresented.</p> </abstract>