Nilotinib Dose, Frequency Reduction Maintains Efficacy in Chronic Myeloid Leukemia
Researchers analyzed the outcomes of 67 patients with BCR-ABL1-positive CML in chronic phase who had an MMR on nilotinib twice daily and who then switched to a once-daily reduced-dose regimen.
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Switching from nilotinib twice daily to once daily at a reduced dose does not compromise clinical activity among patients with chronic myeloid leukemia (CML) who have a major molecular response (MMR), according to data presented at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1
Standard nilotinib regimens involve twice-daily oral administration but present a barrier for therapy adherence because of the specificity of scheduling and dietary considerations. Once-daily dosing is recommended only for toxicity-related dose reductions.
For the observational NILO-RED study, researchers analyzed the outcomes of 67 patients with BCR-ABL1-positive CML in chronic phase who had an MMR on nilotinib twice daily and who then switched to a once-daily reduced-dose regimen.
The primary reasons for switching to reduced dose were non-serious adverse events (AEs) and patient convenience. The median duration of once-daily nilotinib was 24 months.
At baseline, 13.4%, 25.4%, and 61.2% of patients had an MMR, MR4, and greater than MR4.5, respectively, and 47.8% of patients had undetectable levels of BCR-ABL1 transcripts.
Two patients lost MMR after dose reduction, but spontaneously recovered it without any treatment modifications. Survival without MMR loss was 97.2% at 12 months, and a molecular response category analysis showed that no patients who were at least MR4 at baseline lost MMR.
At the last follow-up, 6.3%, 16.4%, and 77.6% of patients had MMR, MR4, and greater than MR4.5, respectively; 55.2% of patients had undetectable BCR-ABL1 transcripts levels.
The authors concluded that these “results may pave the way for clinical trials aiming at systematic avoidance of overtreatment and improvement of [patients'] convenience in treatment with nilotinib.”
Read more of Cancer Therapy Advisor's coverage of the American Society of Hematology (ASH) 2017 meeting by visiting the conference page.
- Rea D, Cayuela JM, Dulucq S, Etienne G. Molecular responses after switching from a standard-dose twice-daily nilotinib regimen to a reduced-dose once-daily schedule in patients with chronic myeloid leukemia: a real life observational study (NILO-RED). Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.