title: Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy.
abstract: OBJECTIVE
  To assess, in a Phase I study, whether bladder preservation with concurrent gemcitabine and radiotherapy (RT) influenced patient-reported quality of life (QOL) as determined by the Functional Assessment of Cancer Therapy-Bladder (FACT-BL).
  
  
  METHODS
  Between January 1998 and March 2002, 24 patients with urothelial carcinoma of the bladder were enrolled, and 23 patients underwent transuretheral resection of bladder tumor, followed by twice-weekly gemcitabine with concurrent RT. The initial dose was 10 mg/m2 given twice weekly and increased as tolerated. To assess treatment-related QOL, patients completed the FACT-BL questionnaire.
  
  
  RESULTS
  Of the 24 patients enrolled, 23 (96%) were assessed for toxicity and response. The FACT-generic (G) QOL assessment was obtained from 22 (92%) of 23 patients. No statistically significant difference was found in the FACT-G or FACT-BL or the combination before, during, or after treatment. The FACT-BL values were lower in patients who received higher doses of gemcitabine (greater than 20 mg/m2 versus 20 mg/m2 or less). At least one dose-limiting toxicity (DLT) was experienced by 5 (23%) of 22 patients. The FACT-G values were lower for those patients who experienced DLT (difference of -13.1, P = 0.07). The physical well-being scores for patients who experienced DLT were lower after treatment (difference of -5.2, P = 0.03) compared with those without DLT.
  
  
  CONCLUSIONS
  Concurrent RT and gemcitabine failed to statistically influence patient-reported QOL, although patients who received higher doses reported lower FACT-BL scores. The results of this study suggest that concurrent gemcitabine with conformal RT is a tolerable treatment regimen for bladder preservation, as demonstrated by the excellent treatment compliance and similar FACT measurements.
authors.affiliation: Department ofRadiation Oncology, University of Michigan Medical Center, Ann Arbor, Michigan 48109, USA.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Herman
authors.forename: David C
authors.initials: DC
authors.lastname: Smith
authors.forename: James
authors.initials: J
authors.lastname: Montie
authors.forename: James A
authors.initials: JA
authors.lastname: Hayman
authors.forename: Molly A
authors.initials: MA
authors.lastname: Sullivan
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Kent
authors.forename: Kent A
authors.initials: KA
authors.lastname: Griffith
authors.forename: Peggy
authors.initials: P
authors.lastname: Esper
authors.forename: Howard M
authors.initials: HM
authors.lastname: Sandler
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy / Q000523:psychology* / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy / Q000523:psychology; D015653:Cystectomy / Q000379:methods; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000209:etiology; D011446:Prospective Studies; D011788:Quality of Life; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011880:Radiotherapy Planning, Computer-Assisted; D011795:Surveys and Questionnaires; D013921:Thrombocytopenia / Q000139:chemically induced / Q000209:etiology; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000523:psychology* / Q000532:radiotherapy / Q000601:surgery; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D011838:Radiation-Sensitizing Agents; D003841:Deoxycytidine; D000093542:Gemcitabine