Dr. Mahon and his colleagues reported that 73 (58%) patients in the TFR phase maintained TFR at 48 weeks, 67 of whom had MR4.5. Of the seven patients who had a loss of MR4.5, four did not have a loss of MMR or confirmed loss of MR4, according to the researchers.
While the primary endpoint was TFR at 48 weeks, the researchers reported that 53% of patients maintained TFR at 96 weeks. Some patients had reinitiated nilotinib by the 96-week cutoff. Of those patients, the study showed that 93% regained MR4 and MR4.5.
The researchers noted that the safety findings were consistent with previously published data of nilotinib. “Improvements in quality of life have been cited as a motivator for stopping treatment,” they wrote. “Minimal changes in quality of life were seen with treatment cessation, possibly because the patients in this study already had a relatively high quality of life, given that they had tolerated at least 3 years of nilotinib therapy before stopping treatment.”
Novartis Pharmaceuticals funded the study. Dr. Mahon and other researchers reported financial ties to several pharmaceutical companies, including Novartis.
SOURCE: Mahon FX et al. Ann Intern Med. 2018 Feb 20. .