title: Biweekly carboplatin/gemcitabine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: report of efficacy, quality of life and geriatric assessment.
abstract: OBJECTIVE
  We evaluated safety and efficacy of first-line gemcitabine/carboplatin in unfit-for-cisplatin patients with advanced urothelial carcinoma and the effect on the quality of life and functional status of elderly patients (aged >70).
  
  
  METHODS
  Unfit patients had ECOG performance status (PS) > or =2, creatinine clearance <50 ml/min or comorbidities precluding cisplatin administration. Carboplatin at area under the curve of 2.5 and gemcitabine 1,250 mg/m(2) were administered biweekly. Elderly patients were stratified into group 1 (no activities of daily living (ADL) or instrumental ADL dependency and no comorbidities), group 2 (instrumental ADL dependency or 1-2 comorbidities) and group 3 (ADL dependency or > or =2 comorbidities).
  
  
  RESULTS
  Thirty-four patients were enrolled: 68% had PS 2-3, 69% a creatinine clearance <50 ml/min and 65% had 1 or more comorbidities. There were 3 cases of grade 3 toxicity (9%). Response rate was 24% [95% confidence interval (CI) 11-41]. Median follow-up was 8 months, median progression-free survival 4.4 months (95% CI 1.03-7.75) and median overall survival 9.8 months (95% CI 4.7-14.9). Patients in geriatric assessment groups 1 and 2 had a significantly longer median progression-free survival compared to group 3 [6.9 months (95% CI 1.3-12.4) vs. 1.9 months (95% CI 0.5-3.2); p = 0.005].
  
  
  CONCLUSIONS
  First-line gemcitabine/carboplatin combination is active in unfit-for-cisplatin patients with advanced urothelial carcinoma. Pretreatment quality of life and geriatric assessment may be useful in selecting patients likely to benefit from this treatment.
authors.affiliation: Department of Clinical Therapeutics, Medical School, University of Athens, Athens, Greece. abamias@med.uoa.gr <abamias@med.uoa.gr>
authors.forename: Aristotle
authors.initials: A
authors.lastname: Bamias
authors.forename: George
authors.initials: G
authors.lastname: Lainakis
authors.forename: Efstathios
authors.initials: E
authors.lastname: Kastritis
authors.forename: Nikos
authors.initials: N
authors.lastname: Antoniou
authors.forename: Gerassimos
authors.initials: G
authors.lastname: Alivizatos
authors.forename: Andreas
authors.initials: A
authors.lastname: Koureas
authors.forename: Michael
authors.initials: M
authors.lastname: Chrisofos
authors.forename: Andreas
authors.initials: A
authors.lastname: Skolarikos
authors.forename: Evangelos
authors.initials: E
authors.lastname: Karayiotis
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000009:adverse effects; D003404:Creatinine / Q000378:metabolism; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D003404:Creatinine; D016190:Carboplatin; D002945:Cisplatin; D000093542:Gemcitabine