The health-related quality-of-life impact of histamine dihydrochloride plus interleukin-2 compared with interleukin-2 alone in patients with metastatic melanoma.
The aim of this study was to compare the quality-of-life (QOL) effects of interleukin-2 (IL-2) alone with those of IL-2 plus histamine dihydrochloride in the setting of a multicenter, randomized trial for patients with metastatic melanoma. QOL data were collected from July 1997 to March 2000 during a phase III trial comparing subcutaneous histamine plus IL-2 and IL-2 alone. Prior to each treatment cycle, patients completed the 76-item Quality-of-Well-Being Scale-Self-Administered (QWB-SA) questionnaire, the Overall State of Health (OSH) item, and the General Health Perception (GHP) item. A longitudinal data analysis using the generalized estimating equations approach was performed to compare changes in QWB-SA scores over time between treatment groups, and predicted QWB-SA scores from the regression analysis were used to calculate quality-adjusted survival duration over the 12-month study period. QOL analyses were conducted for all randomized patients (intent-to-treat overall population, ITT-OA) and all patients who had liver metastases at randomization (ITT-LM population). In the ITT-OA population, differences in QWB-SA scores over time between the histamine plus IL-2 group (150 patients) and the IL-2 alone group (151 patients) were not significant (P=0.511, type III F test). In the ITT-LM population (53 histamine plus IL-2 patients and 73 IL-2 alone patients), changes in QWB-SA scores over time favored the histamine plus IL-2 group (P=0.018, type III F-test). In both the ITT-OA and ITT-LM populations, QWB-SA scores deteriorated more quickly over time in the IL-2 alone group than in the histamine plus IL-2 group, resulting in a significant difference in median quality-adjusted survival duration in favor of the histamine plus IL-2 group by 31.3 days in the ITT-OA population (P=0.007, Mann-Whitney U-test), and 50.2 days in the ITT-LM population (P=0.011). OSH and GHP scores did not differ between groups. The addition of subcutaneous histamine dihydrochloride to IL-2 treatment improved median quality-adjusted survival duration and did not adversely affect QOL in patients with malignant melanoma.
Covance Health Economics and Outcomes Services Inc., 9th Floor, 9801 Washingtonian Blvd., Gaithersburg, MD 20878, USA.
Kathleen M
KM
Beusterien
Stacey J
SJ
Ackerman
Kathryn
K
Plante
John
J
Glaspy
Peter
P
Naredi
Diana
D
Wood
Kurt
K
Gehlsen
Sanjiv S
SS
Agarwala
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006632:Histamine / Q000008:administration & dosage; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000523:psychology* / Q000556:secondary; D008875:Middle Aged; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012044:Regression Analysis; D015203:Reproducibility of Results; D012803:Sick Role; D011795:Surveys and Questionnaires; D013997:Time Factors
D007376:Interleukin-2; D006632:Histamine