Imatinib Intolerance

Incidence of Imatinib Intolerance

Grades 3 and 4 neutropenia and thrombocytopenia occurred in 13% and 7%, respectively, of newly diagnosed chronic phase patients treated with imatinib. Haematologic toxicity was more common in advanced disease. Non-haematologic toxicity led to discontinuation of therapy in 2%-5% of patients and was more likely to occur in patients in advanced phases.⁴

In a 5-year follow-up of patients receiving imatinib for newly diagnosed chronic phase CML, grade 3 or 4 adverse events included neutropenia (17%), thrombocytopenia (9%), anaemia (4%), elevated liver enzymes (5%), and other drug-related events (17%). Event rates were lower after the first 2 years.¹⁵

Study design

Phase III, multicentre, international, open-label, randomised study of 553 newly diagnosed Chronic Phase CML patients who received 400 mg/day imatinib and 553 newly diagnosed Chronic Phase CML patients who received interferon-alfa plus cytarabine.

Median follow-up: 5 years

Primary endpoint: Event-Free Survival*†

Secondary endpoints: Rate of Complete Haematologic Response; a cytogenetic response in marrow cells categorised as complete, partial or major (complete plus partial responses); progression to the Accelerated Phase or Blast Crisis; Overall Survival; safety; and tolerability

• *Referred to in previous presentations and articles as the time to progression, or progression-free survival.
• †Events were defined by the first occurrence of any of the following: death from any cause during treatment, progression to the accelerated phase or blast crisis of CML, or loss of a complete hematologic or major cytogenetic response.

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Cross-Intolerance with imatinib

SPRYCEL: Minimal cross-intolerance with imatinib at 2-year minimum follow-up

The majority of imatinib-intolerant patients with chronic phase CML were able to tolerate treatment with SPRYCEL

• 10 of the 214 imatinib-intolerant patients had the same grade 3 or 4 non-haematologic toxicity with SPRYCEL as they did with prior imatinib
• However, 8 of these 10 patients were able to continue SPRYCEL treatment after dose reduction

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