TY - JOUR
T1 - Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients with CML-CP
T2 - The ENRICH Study
AU - Cortes, Jorge E.
AU - Lipton, Jeffrey H.
AU - Miller, Carole B.
AU - Busque, Lambert
AU - Akard, Luke P.
AU - Pinilla-Ibarz, Javier
AU - Keir, Christopher
AU - Warsi, Ghulam
AU - Lin, Felice P.
AU - Mauro, Michael J.
N1 - Publisher Copyright:
© 2016 The Authors.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - Chronic treatment-related adverse events adversely affect quality of life, treatment adherence, and clinical outcomes of many patients taking imatinib. The ENRICH (Exploring Nilotinib to Reduce Imatinib Related Chronic Adverse Events) study evaluated the effect of switching 52 such patients to nilotinib. Within 3 months of switching, improvements in imatinib-related adverse events and quality of life and ongoing achievement and maintenance of molecular and cytogenetic responses were observed. 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.
AB - Chronic treatment-related adverse events adversely affect quality of life, treatment adherence, and clinical outcomes of many patients taking imatinib. The ENRICH (Exploring Nilotinib to Reduce Imatinib Related Chronic Adverse Events) study evaluated the effect of switching 52 such patients to nilotinib. Within 3 months of switching, improvements in imatinib-related adverse events and quality of life and ongoing achievement and maintenance of molecular and cytogenetic responses were observed. 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.
KW - Chronic myeloid leukemia
KW - Clinical trials
KW - Imatinib-related chronic adverse events
KW - Nilotinib
KW - Switch
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U2 - 10.1016/j.clml.2016.02.002
DO - 10.1016/j.clml.2016.02.002
M3 - Article
C2 - 26993758
AN - SCOPUS:84961135850
SN - 2152-2650
VL - 16
SP - 286
EP - 296
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 5
ER -