title: Quality of life analyses in a clinical trial of DPPE (tesmilifene) plus doxorubicin versus doxorubicin in patients with advanced or metastatic breast cancer: NCIC CTG Trial MA.19.
abstract: BACKGROUND
  DPPE (tesmilifene) plus doxorubicin (DOX) demonstrated a significant improvement in survival versus DOX in a phase III clinical trial in advanced breast cancer. However, DPPE is associated with unusual toxicity in the form of hallucinations, nausea and vomiting which were anticipated to impact on short-term quality of life (QOL).
  
  
  METHODS
  Standard National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) approaches were applied as the primary method to analyze the QOL data from this trial. This includes cross-sectional comparisons, together with a global test for the QOL response rate. Sensitivity analyses were also performed for selected QOL domains and items, using other types of summary measures and statistics.
  
  
  RESULTS
  Two hundred seventy one patients (89% of randomized) submitted the baseline QOL questionnaires and were included in the QOL analysis. No statistically significant difference in QOL response between treatment arms was found for any domain or item except nausea and vomiting (P = 0.04). Cross-sectional comparisons showed statistically significant differences for some domains/items at specific assessment times with all differences favoring the DOX alone arm. Patients on DPPE/DOX arm were significantly worse in terms of average and median pain change scores.
  
  
  CONCLUSIONS
  Different analyses yielded slightly different conclusions but, in general, the QOL analyses were concordant and showed that patients on DOX alone had fewer disease and treatment related adverse events and better QOL. Interestingly, the QOL response analysis also showed that aggressive premedication regimens appear to ameliorate potential negative effects of DPPE on emesis and nausea as measured by patient assessed QOL.
authors.affiliation: National Cancer Institute of Canada Clinical Trials Group, Cancer Research Institute, Queens University, 10 Stuart Street, K7L3N6, Kingston, Ontario, Canada.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Liu
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Tu
authors.forename: Janet
authors.initials: J
authors.lastname: Dancey
authors.forename: Leonard
authors.initials: L
authors.lastname: Reyno
authors.forename: Kathleen I
authors.initials: KI
authors.lastname: Pritchard
authors.forename: Joseph
authors.initials: J
authors.lastname: Pater
authors.forename: Lesley K
authors.initials: LK
authors.lastname: Seymour
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003430:Cross-Sectional Studies; D004317:Doxorubicin / Q000008:administration & dosage; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006304:Health Status; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D020258:Neurotoxicity Syndromes / Q000209:etiology; D010349:Patient Compliance; D010647:Phenyl Ethers / Q000008:administration & dosage; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D010647:Phenyl Ethers; D004317:Doxorubicin; C043062:tesmilifene