Nilotinib Dose, Frequency Reduction Maintains Efficacy in Chronic Myeloid Leukemia

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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.
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 following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.

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.

Reference

  1. 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.

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