title: Subjective and objective prospective, long-term analysis of quality of life during inhaled interleukin-2 immunotherapy.
abstract: OBJECTIVE
  We conducted both a subjective and objective, prospective quality-of-life analysis during high-dose (36 x 10(6) immunizing units/d) inhalational interleukin (IL)-2 treatment (mean treatment time, 13.4 months) of 15 patients with metastatic renal cell carcinoma (mRCC). Additionally, quality of life for 10 patients with mRCC receiving low-dose (9 x 10(6) IU/m(2)/d for 5 days) intravenous IL-2 treatment also was evaluated.
  
  
  METHODS
  Patients responded to the European Organization for Research and Treatment of Cancer quality-of-life questionnaire QLQ-C30 before and during inhalational IL-2 treatment at 1, 3, 6, 9, and 12 months and before and once during intravenous IL-2 treatment. A clinician assessed patient well-being using the Quality of Well-Being scale to calculate once weekly quality-adjusted life-years (QALYs) during inhalational IL-2 treatment.
  
  
  RESULTS
  Patients completed 103 questionnaires and clinicians performed 892 QALY calculations. For patients treated with inhalational IL-2, the mean quality-of-life score deteriorated modestly but significantly 1 month after treatment initiation (15.1%, P =.01) but did not differ significantly from pretreatment scores after 3, 6, 9, and 12 months of treatment. Inhalational IL-2 therapy stabilized patient quality of life for a mean of 13.4 months. The resulting QALY calculation for patients on inhalation IL-2 was 70.1% of 13.4 months, representing 9.4 months of QALY. In comparison, patients who received intravenous IL-2 showed a more marked, statistically significant deterioration in mean quality-of-life score during treatment (27%, P =.006); moreover, three of these 10 patients experienced treatment-related toxicity that prevented questionnaire completion.
  
  
  CONCLUSIONS
  Quality-of-life analysis during immunotherapy provides valuable information regarding cancer treatment outcomes.
authors.affiliation: Department of Urology, University of Hamburg, Hamburg, Germany. heinzer@uhr.uni-hamburg.de
authors.forename: H
authors.initials: H
authors.lastname: Heinzer
authors.forename: T S
authors.initials: TS
authors.lastname: Mir
authors.forename: E
authors.initials: E
authors.lastname: Huland
authors.forename: H
authors.initials: H
authors.lastname: Huland
mesh_terms: D000203:Activities of Daily Living; D000280:Administration, Inhalation; D000328:Adult; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000523:psychology* / Q000556:secondary; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000523:psychology* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D011795:Surveys and Questionnaires
chemical_list: D007376:Interleukin-2