title: Evaluating the Impact of a Switch to Nilotinib on Imatinib-Related Chronic Low-Grade Adverse Events in Patients With CML-CP: The ENRICH Study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: jcortes@mdanderson.org.
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Cortes
authors.affiliation: Princess Margaret Cancer Center, University of Toronto, Toronto, ON, Canada.
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Lipton
authors.affiliation: St. Agnes Hospital, Baltimore, MD.
authors.forename: Carole B
authors.initials: CB
authors.lastname: Miller
authors.affiliation: University of Montreal, Maisonneuve-Rosemont Hospital, Montreal, QC, Canada.
authors.forename: Lambert
authors.initials: L
authors.lastname: Busque
authors.affiliation: Indiana Blood and Marrow Transplantation, Indianapolis, IN.
authors.forename: Luke P
authors.initials: LP
authors.lastname: Akard
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
authors.forename: Javier
authors.initials: J
authors.lastname: Pinilla-Ibarz
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ.
authors.forename: Christopher
authors.initials: C
authors.lastname: Keir
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ.
authors.forename: Ghulam
authors.initials: G
authors.lastname: Warsi
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ.
authors.forename: Felice P
authors.initials: FP
authors.lastname: Lin
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mauro
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate / Q000009:adverse effects / Q000627:therapeutic use; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate; C498826:nilotinib
keywords: Chronic myeloid leukemia; Clinical trials; Imatinib-related chronic adverse events; Nilotinib; Switch