Abstract
To determine whether a lower imatinib dose could minimize toxicity while maintaining the molecular response (MR), imatinib dose was reduced to 300 mg daily in 43 patients with chronic myeloid leukemia (CML) in sustained deep molecular response to first-line imatinib 400 mg daily. At the time of dose reduction, median duration of the deep response was 4.1 (interquartile range (IQR) 2.2–5.9) years; molecular response was MR4, MR4.5, and MR5 of the international scale in 6, 28, and 9 patients, respectively. Toxicity grade was 1, 2, and 3 in 28, 8, and 1 patients, respectively; 6 patients underwent dose reduction without having side effects. With a median of 1.6 (IQR 0.7–3.2) years on imatinib 300 mg daily, only one patient lost the deep molecular response to MR3. At the last follow-up, response was MR3, MR4, MR4.5, and MR5 in 1, 3, 9, and 30 patients, respectively. Toxicity improvement was observed in 23 (62.2 %) of the 37 patients with side effects, decreasing to grade 0 in 20 of them. All but one anemic patients improved (p = 0.01), the median Hb increase in this subgroup of patients being 1 g/dL. In CML patients with sustained deep response to the standard imatinib dose, reducing to 300 mg daily significantly improves tolerability and preserves efficacy.
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This study has been supported in part by grants RD012/0036/0004 and RD012/0036/0010 from the Instituto de Salud Carlos III, Spanish Ministry of Health and by AMPILE.
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This collaborative study was performed in seven centers within the framework of the Spanish CML Group. It was approved by the Spanish Drug Agency, and since the intervention was considered as routine clinical practice to minimize imatinib side effects, patients’ signed informed consent was not deemed necessary by the Ethics Committee for approval.
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The authors declare that they have no conflict of interest.
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Cervantes, F., Correa, JG., Pérez, I. et al. Imatinib dose reduction in patients with chronic myeloid leukemia in sustained deep molecular response. Ann Hematol 96, 81–85 (2017). https://doi.org/10.1007/s00277-016-2839-z
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DOI: https://doi.org/10.1007/s00277-016-2839-z