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Prepublished online as a Blood First Edition Paper on April 17, 2002; DOI 10.1182/blood-2001-12-0154.
Submitted December 4, 2001
Accepted January 10, 2002
Phase II Trial of STI571 in Myelofibrosis with Myeloid Metaplasia
Ayalew Tefferi*, Ruben A Mesa, Leigh A Gray, David P Steensma, John K Camoriano, Michelle A Elliott, Animesh Pardanani, Stephen M Ansell, Timothy G Call, Gerardo Colon-Otero, Georgene Schroeder, Curtis A Hanson, Gordon W Dewald, and Scott H Kaufmann
Division of Hematology, Mayo Clinic, Rochester, MN, USA
Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, USA
Division of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA
* Corresponding author; email: tefferi.ayalew{at}mayo.edu.
In a phase II study, 23 patients with myelofibrosis with myeloid metaplasia (MMM) were treated with STI571 at a constant dose of 400 mg/day. Treatment was held in 16 patients (70%), after 1-12 weeks, because of side effects (neutropenia, 6 cases; musculoskeletal pain, 5 cases; thrombocytosis, 4 cases; edema, 3 cases; diarrhea and hyperbilirubinemia, 1 case). Including patients where re-treatment at a reduced dose was possible, 11 patients (48%) were able to continue treatment beyond 3 months. None of the patients experienced a response in anemia and only two had partial responses in splenomegaly. A greater than 50% increase in platelet count was documented in 11 patients (48%) but not in those with baseline platelet counts of <100 x 109/L. In vitro, STI571 caused variable degrees of growth suppression of both myeloid and erythroid progenitors that unfortunately did not translate into clinical benefit.
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