Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment

• Published in: Health and quality of life outcomes Vol. 10; no. 1; p. 66
• Main Authors: Revicki, Dennis A, van den Eertwegh, Alfons J M, Lorigan, Paul, Lebbe, Celeste, Linette, Gerald, Ottensmeier, Christian H, Safikhani, Shima, Messina, Marianne, Hoos, Axel, Wagner, Samuel, Kotapati, Srividya
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 13.06.2012; BioMed Central; BMC
• Subjects: Advanced melanoma; Analysis; Antibodies, Monoclonal - therapeutic use; Antineoplastic Agents - therapeutic use; Cancer; Cancer patients; Cancer Vaccines - therapeutic use; Care and treatment; Clinical trials; Combined Modality Therapy; Double-Blind Method; Drug therapy; EORTC QLQ-C30; Female; Health; Health aspects; Health Status Indicators; Health-related quality of life; Humans; Ipilimumab; Male; Measurement; Melanoma; Melanoma - psychology; Melanoma - secondary; Melanoma - therapy; Middle Aged; Neoplasm Staging; Oncology, Experimental; Patient outcomes; Peptides; Pharmaceutical industry; Quality of Life; Randomized clinical trial; Skin cancer; Studies; Surveys; Vaccines; United States
• ISSN: 1477-7525; 1477-7525
• DOI: 10.1186/1477-7525-10-66

In an international, randomized Phase III trial ipilimumab demonstrated a significant overall survival benefit in previously treated advanced melanoma patients. This report summarizes health-related quality of life (HRQL) outcomes for ipilimumab with/without gp100 vaccine compared to gp100 alone during the clinical trial's 12 week treatment induction period. The Phase III clinical trial (MDX010-20) was a double-blind, fixed dose study in 676 previously treated advanced unresectable stage III or IV melanoma patients. Patients were randomized 3:1:1 to receive either ipilimumab (3 mg/kg q3w x 4 doses) + gp100 (peptide vaccine; 1 mg q3w x 4 doses; ipilimumab plus gp100, n = 403); gp100 vaccine + placebo (gp100 alone, n = 136); or ipilimumab + placebo (ipilimumab alone, n = 137). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assessed HRQL. Baseline to Week 12 changes in EORTC QLQ-C30 function, global health status, and symptom scores were analyzed for ipilimumab with/without gp100 vaccine compared to gp100 alone. Mean change in scores were categorized "no change" (0-5), "a little" (5-10 points), "moderate" (10-20 points), and "very much" (>20). In the ipilimumab plus gp100 and ipilimumab alone groups, mean changes from baseline to Week 12 generally indicated "no change" or "a little" impairment across EORTC QLQ-C30 global health status, function, and symptom subscales. Significant differences in constipation, favoring ipilimumab, were observed (p < 0.05). For ipilimumab alone arm, subscales with no or a little impairment were physical, emotional, cognitive, social function, global health, nausea, pain, dyspnea, constipation, and diarrhea subscales. For the gp100 alone group, the observed changes were moderate to large for global health, role function, fatigue, and for pain. Ipilimumab with/without gp100 vaccine does not have a significant negative HRQL impact during the treatment induction phase relative to gp100 alone in stage III or IV melanoma patients. Clinicaltrials.gov identification number NCT00094653.