Clinical and health-related quality of life (HRQoL) information was analyzed to 
determine: (a) patient-reported signs, symptoms, and functioning, (b) HRQoL 
questionnaire psychometrics, and (c) treatment impact on HRQoL. Data from the 
Melanoma Subscale (MS) of the Functional Assessment of Cancer Therapy-Melanoma 
and the worst pain question from the Brief Pain Inventory (BPI) were taken from 
a clinical trial evaluating intetumumab alone or with dacarbazine in Stage IV 
metastatic melanoma. Descriptive statistics examined patient-reported disease 
burden at baseline. Correlations explored clinical endpoint and HRQoL 
associations. Psychometrics included Cronbach's α internal consistency and 
intraclass correlation coefficient (ICC). Treatment impact on HRQoL was 
evaluated through HRQoL maintenance and response analyses. Patients (n=127) had 
a mean age of 62 years, a mean±SD hemoglobin of 13.0±2.6 g/dl, and a mean±SD 
lactic dehydrogenase of 394±454 IU/l. Ninety-eight percent were Caucasian, 67% 
were men, and 64% had an Eastern Cooperative Oncology Group status of 0. 
Baseline BPI worst pain and MS scores (mean±SD) were 1.6±2.2 and 54.5±7.2, 
respectively. Top three patient-reported health decrements in the MS were 
appetite, fatigue, and limited physical activity. Observed HRQoL decrements were 
consistent with the literature. MS and BPI worst pain item demonstrated good 
psychometrics: Cronbach's α and ICC for the MS were 0.79 and 0.86, respectively; 
BPI ICC was 0.74. A trend for HRQoL response was observed 3 weeks postbaseline 
in the dacarbazine + 10 mg/kg intetumumab arm compared with dacarbazine + 
placebo: 22 versus 10%, respectively, for the MS; 23 versus 5% for the BPI. 
Further research on the HRQoL benefit of intetumumab in larger studies appears 
warranted.