title: Impact of imatinib rechallenge on health-related quality of life in patients with TKI-refractory gastrointestinal stromal tumours: Sub-analysis of the placebo-controlled, randomised phase III trial (RIGHT).
abstract: BACKGROUND
  The RIGHT trial demonstrated that resumption of imatinib significantly improves progression-free survival in patients with tyrosine-kinase inhibitor-refractory gastrointestinal stromal tumours. The impact of imatinib on health-related quality of life (QoL) was assessed in a preplanned sub-analysis.
  
  
  METHODS
  QoL was assessed at baseline and every 4 weeks using European Organization for Research and Treatment Quality of Life Questionnaire C30, version 3.0. QoL data were collected only during the double-blind treatment period. The evolution of QoL parameters over time was assessed by analysis of variance with repeated measures, and comparisons between the two arms at each treatment cycle were performed by analysis of covariance after adjusting for baseline values.
  
  
  RESULTS
  At baseline, 4 weeks, and 8 weeks after treatment, 35 (88% of enrolled patients), 32 (82%), and 21 (95%) patients in the placebo arm and 37 (90%), 33 (85%), and 25 (83%) patients in the imatinib arm, respectively, were evaluable for QoL analysis. In the longitudinal comparison, no differences in global health status/QoL, functioning and other symptom scales were observed between the two groups, although insomnia was significantly worse in the placebo group (p = 0.02). Cross-sectionally, at 8 weeks, pain was better (p = 0.04) and nausea/vomiting, appetite loss, and diarrhoea were worse (p = 0.002, p = 0.01, and p = 0.04, respectively) in the imatinib group than in the placebo group, with no differences in global health status/QoL and functional scales.
  
  
  CONCLUSIONS
  Despite the toxicity of imatinib, QoL was not impaired in this fragile patient population. The benefits of imatinib rechallenge outweigh its toxicities, supporting its clinical relevance for patients without active treatment options.
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Changhoon
authors.initials: C
authors.lastname: Yoo
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Min-Hee
authors.initials: MH
authors.lastname: Ryu
authors.affiliation: Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, South Korea.
authors.forename: Byung-Ho
authors.initials: BH
authors.lastname: Nam
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Baek-Yeol
authors.initials: BY
authors.lastname: Ryoo
authors.affiliation: Ludwig Center at Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
authors.forename: George D
authors.initials: GD
authors.lastname: Demetri
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Electronic address: ykkang@amc.seoul.kr.
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004311:Double-Blind Method; D019008:Drug Resistance, Neoplasm; D057915:Drug Substitution; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality / Q000473:pathology; D046152:Gastrointestinal Stromal Tumors / Q000188:drug therapy* / Q000201:enzymology / Q000401:mortality / Q000473:pathology; D006801:Humans; D000068877:Imatinib Mesylate / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D056910:Republic of Korea; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D000068877:Imatinib Mesylate
keywords: Gastrointestinal stromal tumour; Imatinib; Quality of life; Rechallenge