Research
Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment
1 United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD, 20814, USA
2 VU University Medical Center, Boelelaan 1117 1081HV, Amsterdam, The Netherlands
3 University of Manchester, Christie NHS Foundation Trust Wilmslow Road, Manchester, M20 4BX, UK
4 Hôpital St. Louis, APHP Dermatology University Paris 7, Diderot, France
5 Division of Oncology, Washington University School of Medicine, 660 S, Euclid Avenue, Campus Box 8056, St. Louis, MO, 63110, USA
6 Southampton University and University Hospital Southampton, Cancer Sciences Division, Southampton, O16 6YD, UK
7 Bristol-Myers Squibb, 5 Research Parkway, Wallingford, CT, 06492, USA
8 Bristol-Myers Squibb, 100 Nassau Park Boulevard, Princeton, NJ08540, USA
Health and Quality of Life Outcomes 2012, 10:66 doi:10.1186/1477-7525-10-66
Published: 13 June 2012Abstract
Background
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.
Methods
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).
Results
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.
Conclusions
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.
Trial registration
Clinicaltrials.gov identification number NCT00094653
