title: Impact of low-grade adverse events on health-related quality of life in adult patients receiving imatinib or nilotinib for newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.
abstract: OBJECTIVE
  Chronic myeloid leukemia (CML) treatment relies on tyrosine kinase inhibitors (TKIs), but their use can be associated with low-grade adverse events (AEs). This analysis aimed to identify the low-grade AEs which significantly impact the Health Related Quality of Life (HRQoL) of CML patients in chronic phase (CP) and to compare the incidence of such AEs among nilotinib- and imatinib-treated patients.
  
  
  METHODS
  Data from the 48 month ENESTnd trial were used (N = 593 patients). HRQoL was assessed using generic (SF-36) and leukemia-specific (FACT-Leu) HRQoL surveys. AEs were categorized into 26 system organ classes.
  
  
  RESULTS
  In the adjusted regression model, five low-grade AE categories - gastrointestinal disorders, blood and lymphatic system disorders, general disorders and administration site conditions, musculoskeletal disorders, and psychiatric disorders - significantly impaired at least one HRQoL score. The incidence rate of these five AE categories was either significantly lower for nilotinib than imatinib or not different between the two drugs. The AE categories with lower incidence for both nilotinib 300 mg BID and 400 mg BID versus imatinib 400 mg daily were gastrointestinal, blood and lymphatic system, and musculoskeletal; nilotinib 300 mg BID had lower incidence than imatinib for general disorders.
  
  
  CONCLUSIONS
  Low-grade AEs were grouped and analyzed by system organ class category, so the effect of some rare individual AEs on HRQoL may have been missed.
  
  
  CONCLUSIONS
  The impact of low-grade AEs on HRQoL should be taken into account, along with other factors, when selecting the optimal treatment for patients newly diagnosed with CML-CP.
authors.affiliation: Analysis Group Inc. , Montreal, QC , Canada.
authors.forename: Annie
authors.initials: A
authors.lastname: Guérin
authors.forename: Lei
authors.initials: L
authors.lastname: Chen
authors.forename: Raluca
authors.initials: R
authors.lastname: Ionescu-Ittu
authors.forename: Maryna
authors.initials: M
authors.lastname: Marynchenko
authors.forename: Roy
authors.initials: R
authors.lastname: Nitulescu
authors.forename: Robert
authors.initials: R
authors.lastname: Hiscock
authors.forename: Christopher
authors.initials: C
authors.lastname: Keir
authors.forename: Eric Qiong
authors.initials: EQ
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001549:Benzamides / Q000009:adverse effects*; D005260:Female; D006304:Health Status; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D010677:Philadelphia Chromosome; D010879:Piperazines / Q000009:adverse effects*; D011743:Pyrimidines / Q000009:adverse effects*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate; C498826:nilotinib
keywords: Adverse effects; Imatinib; Myelogenous leukemia, chronic; Nilotinib; Quality of life