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Clin Lymphoma Myeloma Leuk. 2016 May;16(5):286-96. doi: 10.1016/j.clml.2016.02.002. Epub 2016 Feb 16.

Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study.

Author information

1
The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: jcortes@mdanderson.org.
2
Princess Margaret Cancer Center, University of Toronto, Toronto, ON, Canada.
3
St. Agnes Hospital, Baltimore, MD.
4
University of Montreal, Maisonneuve-Rosemont Hospital, Montreal, QC, Canada.
5
Indiana Blood and Marrow Transplantation, Indianapolis, IN.
6
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
7
Novartis Pharmaceuticals Corporation, East Hanover, NJ.
8
Memorial Sloan Kettering Cancer Center, New York, NY.

Abstract

BACKGROUND:

Many patients with chronic myeloid leukemia in chronic phase experience chronic treatment-related adverse events (AEs) during imatinib therapy. These AEs can impair quality of life and lead to reduced treatment adherence, which is associated with poor clinical outcomes.

PATIENTS AND METHODS:

In the phase II ENRICH (Exploring Nilotinib to Reduce Imatinib Related Chronic Adverse Events) study (N = 52), the effect of switching patients with imatinib-related chronic low-grade nonhematologic AEs from imatinib to nilotinib was evaluated.

RESULTS:

Three months after switching to nilotinib, 84.6% of the patients had overall improvement in imatinib-related AEs (primary endpoint). Of 210 imatinib-related AEs identified at baseline, 62.9% had resolved within 3 months of switching to nilotinib. Of evaluable patients, most had improvements in overall quality of life after switching to nilotinib. At screening, 65.4% of evaluable patients had a major molecular response (BCR-ABL1 ≤ 0.1% on the International Scale). After switching to nilotinib, the rate of the major molecular response was 76.1% at 3 months and 87.8% at 12 months. Treatment-emergent AEs reported with nilotinib were typically grade 1 or 2; however, some patients developed more serious AEs, and 8 patients discontinued nilotinib because of new or worsening AEs.

CONCLUSION:

Overall, results from the ENRICH study demonstrated that switching to nilotinib can mitigate imatinib-related chronic low-grade nonhematologic AEs in patients with chronic myeloid leukemia in chronic phase, in conjunction with acceptable safety and achievement of molecular responses. This trial was registered at www.clinicaltrials.gov as NCT00980018.

KEYWORDS:

Chronic myeloid leukemia; Clinical trials; Imatinib-related chronic adverse events; Nilotinib; Switch

PMID:
26993758
PMCID:
PMC4965237
DOI:
10.1016/j.clml.2016.02.002
[Indexed for MEDLINE]
Free PMC Article

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