HealthDay News — For patients with chronic-phase chronic myeloid leukemia (CML), treatment-free remission (TFR) appears to be feasible after second-line nilotinib, according to a study published online February 20 in the Annals of Internal Medicine.

François-Xavier Mahon, MD, PhD, from the University of Bordeaux in France, and colleagues conducted an open-label study to assess TFR after discontinuation of second-line nilotinib. Adults with CML in chronic phase who received tyrosine kinase inhibitor (TKI) treatment for at least three years and achieved molecular response (MR)4.5 (BCR-ABL1 ≤0.0032 percent on the International Scale) while receiving nilotinib entered a one-year consolidation phase. Those with sustained MR4.5 during consolidation were able to enter TFR (discontinuation of TKI therapy). 

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A total of 163 patients who had switched from imatinib to nilotinib were enrolled in the study and entered the consolidation phase; 126 of these patients met the criteria for entering the TFR phase. The researchers found that 58 and 53 percent of patients, respectively, maintained TFR at 48 and 96 weeks. Fifty-six patients reinitiated nilotinib therapy; 55 and 52 regained major MR or better and MR4.5, respectively. CML did not progress to accelerated phase or blast crisis in any of the patients. During the first 48 weeks after nilotinib discontinuation, musculoskeletal pain was more frequent.

“TFR seems achievable in patients with sustained MR4.5 after switching to nilotinib,” the authors write.

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Several authors disclosed ties to pharmaceutical companies, including Novartis, which manufactures nilotinib and provided funding for the study.

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