title: Quality of life in good prognosis patients with metastatic germ cell cancer: a prospective study of the European Organization for Research and Treatment of Cancer Genitourinary Group/Medical Research Council Testicular Cancer Study Group (30941/TE20).
abstract: OBJECTIVE
  To describe global quality of life (GLQL) in patients with metastatic testicular cancer (TC) treated with four different schedules of bleomycin, etoposide, and cisplatin (BEP) chemotherapy (four v three cycles given over 5 v 3 days).
  
  
  METHODS
  Quality-of-life data were prospectively collected in 666 patients with metastatic TC entered into the European Organization for Research and Treatment of Cancer (EORTC) Trial 30941/United Kingdom Medical Research Council Trial TE20, using the EORTC Quality-of-Life Questionnaire C30 and a TC module. Data were analyzed by a mixed effects model and by evaluation of clinically relevant changes at 2 years.
  
  
  RESULTS
  The pattern of GLQL changes was similar in the four groups. Two years after chemotherapy, 36% of patients displayed improved GLQL as compared with baseline, whereas GLQL had deteriorated in 13%. At 3 months, patients receiving the 3-day regimen experienced increased gastrointestinal (GI) toxicity more than those receiving the 5-day regimen, with the difference reaching the level of clinical relevance (>or = 10-point change) if four cycles were given. The 3-day schedule increased the 2-year risk of tinnitus, with clinical relevance demonstrated after four cycles. Long-term peripheral neuropathy and Raynaud-like phenomena were not associated with the number of cycles or days per cycle. At 2 years, Raynaud-like phenomena, tinnitus, or reduced hearing were reported by 21% to 26% of the patients.
  
  
  CONCLUSIONS
  Because of the excess of acute GI toxicity and the increased risk of tinnitus after the 3-day regimen, we recommend the 5-day regimen if four cycles of BEP are planned. If only three cycles are to be given, then the 3-day regimen is acceptable, even given the increased risk of nausea/vomiting at 3 months.
authors.affiliation: Norwegian Radium Hospital, Oslo, Norway. s.d.fossa@klinmed.uio.no
authors.forename: Sophie D
authors.initials: SD
authors.lastname: Fosså
authors.forename: Ronald
authors.initials: R
authors.lastname: de Wit
authors.forename: J Trevor
authors.initials: JT
authors.lastname: Roberts
authors.forename: Peter M
authors.initials: PM
authors.lastname: Wilkinson
authors.forename: Pieter H M
authors.initials: PH
authors.lastname: de Mulder
authors.forename: Graham M
authors.initials: GM
authors.lastname: Mead
authors.forename: Pat
authors.initials: P
authors.lastname: Cook
authors.forename: Linda
authors.initials: L
authors.lastname: de Prijck
authors.forename: Sally
authors.initials: S
authors.lastname: Stenning
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D004064:Digestive System / Q000187:drug effects; D004334:Drug Administration Schedule; D004644:Emotions; D005047:Etoposide / Q000008:administration & dosage; D005060:Europe; D018237:Germinoma / Q000188:drug therapy* / Q000523:psychology*; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011379:Prognosis; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012380:Role; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000523:psychology*; D016896:Treatment Outcome
chemical_list: D001761:Bleomycin; D005047:Etoposide; D002945:Cisplatin