Quality of life in patients with advanced melanoma receiving vaccine therapy alone (V) or vaccine with high-dose interleukin-2 (V-HIL2)

Abstract

8549 Background: Melanoma is a public health concern with 1 in 75 Americans diagnosed during their lifetime and 5-year survival rate of about 10% for those with advanced melanoma. With curative options limited, new regimens must be evaluated and attention given to outcomes of how patients feel and function as a result of therapy. Methods: We examined the effect of biotherapy and fatigue on health-related quality of life (HRQL) in patients with stage IV melanoma enrolled in phase II clinical trials at the NCI receiving peptide vaccines with or without high dose IL-2. Generic HRQL was measured by physical (PCS) and mental (MCS) summary scores of the Short Form-36 health survey (SF-36). The Functional Assessment of Cancer Therapy-General (FACT-G) with a fatigue scale (FS) measured disease-specific HRQL and fatigue. Higher scores on measures indicate better physical, emotional, social function and well-being and less fatigue. Between 2000–2003, patients (F=22, M=47; mean age 46 ± 11) completed measures by computer at baseline (BL) and first follow-up after 2 cycles of treatment, before discussion of response to therapy. Data were analyzed using two-way ANCOVA with biotherapy (V or V-HIL2) and fatigue (worse (W) or improved/stable (I/S)) as factors and BL HRQL as covariate. A clinically important difference on FS is reported as 3 points. Fatigue levels with decrease of 3 from BL to follow-up were classified as W and <3 as I/S. Results: Patients were Caucasian (99%), married (77%), BL ECOG 0 or 1 (99%), mean BL Hgb 13 ± 2 and received 2 prior therapies (38%) or more (42%). Adjusting for BL HRQL, there was no biotherapy (p >.30) or interaction effect (p >.60; table ). There was a fatigue effect (p <.001) with lower HRQL adjusted mean scores in W versus I/S. Conclusions: HRQL does not differ in patients with advanced melanoma ECOG 0 or 1 who receive investigational V versus V-HIL2 at follow-up evaluation. Patients’ reporting of worsened fatigue is associated with poorer HRQL, regardless of the biotherapy received. [Table: see text] [Table: see text]