title: Health-related quality-of-life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.
abstract: BACKGROUND
  The phase III CLEOPATRA study demonstrated that combining pertuzumab with trastuzumab plus docetaxel significantly improves progression-free and overall survival in previously untreated HER2-positive metastatic breast cancer. Here, we report health-related quality-of-life (HRQoL) results from CLEOPATRA.
  
  
  METHODS
  Participants were randomly assigned to pertuzumab or placebo, each given with trastuzumab plus docetaxel every 3 weeks. Pertuzumab and trastuzumab were administered until progression and six or more docetaxel cycles were recommended. Time from randomization to a ≥ 5-point decrease in Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire was analyzed as a prespecified secondary end point. A post hoc exploratory analysis investigated time to ≥ 2-point deterioration in Breast Cancer Subscale (BCS) score.
  
  
  RESULTS
  Time to ≥ 5-point decline in TOI-PFB did not differ significantly between the pertuzumab and placebo arms [hazard ratio (HR), 0.97; P = 0.7161]. The median times to TOI-PFB deterioration were 18.4 and 18.3 weeks, respectively (approximately six cycles). The mean TOI-PFB declined slightly until week 18 and recovered thereafter. Pertuzumab increased time until BCS deterioration versus placebo (median 26.7 versus 18.3 weeks; HR, 0.77; P = 0.0061).
  
  
  CONCLUSIONS
  Combining pertuzumab with trastuzumab and docetaxel had no adverse impact on HRQoL and may prolong time to worsening of breast cancer-specific symptoms.
authors.affiliation: Department of Oncology, Vall D'Hebron University Hospital, Barcelona, Spain. Electronic address: jacortes@vhebron.net.
authors.forename: J
authors.initials: J
authors.lastname: Cortés
authors.affiliation: Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, USA.
authors.forename: J
authors.initials: J
authors.lastname: Baselga
authors.affiliation: Division of Hematology/Medical Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.
authors.forename: Y-H
authors.initials: YH
authors.lastname: Im
authors.affiliation: Division of Hematology/Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: S-A
authors.initials: SA
authors.lastname: Im
authors.affiliation: Medical Oncology, CHU Jean Minjoz, Besançon, France.
authors.forename: X
authors.initials: X
authors.lastname: Pivot
authors.affiliation: Medical Affairs, Roche Products Limited, Welwyn, UK.
authors.forename: G
authors.initials: G
authors.lastname: Ross
authors.affiliation: Medical Affairs, Roche Products Limited, Welwyn, UK.
authors.forename: E
authors.initials: E
authors.lastname: Clark
authors.affiliation: Medical Affairs, Roche Products Limited, Welwyn, UK.
authors.forename: A
authors.initials: A
authors.lastname: Knott
authors.affiliation: Washington Cancer Institute, MedStar Washington Hospital Center, Washington, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Swain
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis / Q000188:drug therapy; D010919:Placebos / Q000008:administration & dosage; D011788:Quality of Life; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011795:Surveys and Questionnaires; D013534:Survival; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D000077143:Docetaxel; D010919:Placebos; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human; C485206:pertuzumab
keywords: docetaxel; health-related quality-of-life; metastatic breast cancer; pertuzumab; trastuzumab