title: Quality of Life and Adherence to Therapy in Patients With Chronic Myeloid Leukemia Treated With Nilotinib as a Second-Line Therapy: A Multicenter Prospective Observational Study.
abstract: The aim of this study was to evaluate quality of life (QOL) and adherence to the therapy in patients with chronic myeloid leukemia in chronic phase treated with nilotinib as second-line therapy.
  
  
  
  A multicenter, prospective, observational trial with 6 time points was conducted; 177 patients were recruited in 23 centers in Poland who were treated with nilotinib as second-line therapy because of the ineffectiveness or intolerance of their previous therapy. QOL was evaluated with the standard European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire. Adherence to the therapy was assessed using the 4-item Morisky Medication Adherence Scale by patients and their physicians.
  
  
  
  The average QOL in patients who completed the study was significantly higher during the last visit (69.4 ± 17.4) than at the start of the study (59.1 ± 18.8; P < .001). At their first visit, 120 (83.2%) patients assessed themselves as highly compliant and 135 (93.4%) at the fifth visit. Low-compliance patients represented 3 (1.7% of the total) during visit 1; none of the patients self-assessed as low compliance since the fourth visit. At the first visit 151 (85.3%) patients were categorized by their physicians as highly compliant and 138 (96.0%) during the last 3 visits. Patients' and their physicians' assessments were significantly correlated.
  
  
  
  The QOL among patients receiving nilotinib administered as second-line therapy was very good and adherence to the treatment was high. The efficacy and safety of the drug were confirmed in the real-life setting.
authors.affiliation: Department of Hematology, Jagiellonian University Hospital, Kraków, Poland. Electronic address: sachatom@gmail.com.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Sacha
authors.affiliation: Institute of Hematology and Transfusion Medicine, Warszawa, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Góra-Tybor
authors.affiliation: Novartis Poland, Warszawa, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Wąsak-Szulkowska
authors.affiliation: Department of Hematology and Bone Marrow Transplantation, Silesian Medical University, Katowice, Poland.
authors.forename: Sławomira
authors.initials: S
authors.lastname: Kyrcz-Krzemień
authors.affiliation: Department of Hematology, Malignant Blood Diseases and Bone Marrow Transplantation, Wroclaw Medical University, Wrocław, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Mędraś
authors.affiliation: Department of Hematology, Pomeranian Medical University in Szczecin, Szczecin, Poland.
authors.forename: Rafał
authors.initials: R
authors.lastname: Becht
authors.affiliation: Department of Hematology and Bone Marrow Transplantation, Silesian Medical University, Katowice, Poland.
authors.forename: Grażyna
authors.initials: G
authors.lastname: Bober
authors.affiliation: Novartis Poland, Warszawa, Poland.
authors.forename: Aneta
authors.initials: A
authors.lastname: Kotowska
authors.affiliation: Department of Hematology, Jagiellonian University Hospital, Kraków, Poland.
authors.forename: Joanna
authors.initials: J
authors.lastname: Wącław
authors.affiliation: Department of Hematology and Transplantology, Gdansk Medical University, Gdańsk, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Hellmann
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use*; D011788:Quality of Life; D016879:Salvage Therapy / Q000379:methods; D011795:Surveys and Questionnaires; D016903:Drug Monitoring
chemical_list: D000970:Antineoplastic Agents; D011743:Pyrimidines; C498826:nilotinib
keywords: CML; Drug compliance; Second generation tyrosine kinase inhibitor treatment; Therapy outcome on doctor's perspective; Therapy outcome on patient's perspective