title: Quality of life under capecitabine (Xeloda®) in patients with metastatic breast cancer: data from a german non-interventional surveillance study.
abstract: OBJECTIVE
  This non-interventional surveillance study (NIS) collected data on the quality of life (QoL) of patients treated with capecitabine as mono- or combination chemotherapy in an outpatient setting.
  
  
  METHODS
  Capecitabine was administered orally for 14 days of each 21-day cycle. The main parameters of interest were QoL, compliance, patient and physician satisfaction, handling of hand-foot syndrome (HFS), and efficacy. The statistics were descriptive; some differences were compared using confidence intervals (CIs).
  
  
  RESULTS
  735 patients from 161 centers received at least 1 dose of capecitabine. The median duration of observation was 5.5 months overall. The QoL global score was 53% (mean from the entire study population at all times), without any correlation to HFS. The overall response rate (ORR) was 35.1%, and the disease control rate (DCR) 64.4%. The median progression-free survival (PFS) was overall 6.81 months (95% CI 6.32-7.63 months) and it was significantly higher in patients with HFS (8.4 months, 95% CI 7.5-9.2 months, hazard ratio (HR) 0.60; p < 0.0001). The safety and tolerability of capecitabine were considered acceptable. The HFS incidence (all grades) was 27.1%.
  
  
  CONCLUSIONS
  Capecitabine had a favorable risk-benefit relation in outpatient therapy. The QoL remained stable over the course of the investigation, indicating good compliance. HFS was a strong predictor of longer PFS and had no negative impact on the global QoL.
authors.affiliation: Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Volkmar
authors.initials: V
authors.lastname: Müller
authors.forename: Stefan
authors.initials: S
authors.lastname: Fuxius
authors.forename: Claus-Christoph
authors.initials: CC
authors.lastname: Steffens
authors.forename: Christian
authors.initials: C
authors.lastname: Lerchenmüller
authors.forename: Birgit
authors.initials: B
authors.lastname: Luhn
authors.forename: Ursula
authors.initials: U
authors.lastname: Vehling-Kaiser
authors.forename: Ursula
authors.initials: U
authors.lastname: Hurst
authors.forename: Lars-Jörgen
authors.initials: LJ
authors.lastname: Hahn
authors.forename: Ulrike
authors.initials: U
authors.lastname: Soeling
authors.forename: Tim
authors.initials: T
authors.lastname: Wohlfarth
authors.forename: Matthias
authors.initials: M
authors.lastname: Zaiss
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005858:Germany; D060831:Hand-Foot Syndrome / Q000209:etiology / Q000523:psychology; D006801:Humans; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011788:Quality of Life / Q000523:psychology*; D018570:Risk Assessment / Q000379:methods; D011795:Surveys and Questionnaires
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil