Fewer Hematologic Adverse Events With Gleevec®1,2

• Grade 3 neutropenia was observed in 11% of patients in the Gleevec group and in 20% of patients in the IFN-α + ara-C group.

• Grade 3 thrombocytopenia occurred in 7% of patients in the Gleevec group and in 16% in the IFN-α + ara-C group.

• Overall, myelosuppression was more severe in the IFN-α + ara-C group than in the Gleevec group.

• Myelosuppression with Gleevec was also less severe in de novo patients compared with patients in chronic phase who failed IFN-α treatment (phase II trial, study 110). This difference may reflect a larger pool of normal hematopoietic stem cells in newly diagnosed patients.3

• Common Toxicity Criteria grades: neutropenia (grade 3 ≥0.5-1.0 x 109/L, grade 4 <0.5 x 109/L); thrombocytopenia (grade 3 ≥10-50 x 109/L, grade 4 <10 x 109/L); anemia (hemoglobin ≥65-80 g/L, grade 4 <65 g/L).

References

1. Gleevec® (imatinib mesylate) Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2003.

2. Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.

3. Kantarjian H, Sawyers C, Hochhaus A, et al. Hematologic and cytogenetic responses to imatinib mesylate in chronic myelogenous leukemia. N Engl J Med. 2002;346:645-652.