Electronic supplementary material
The online version of this article (doi:10.1186/1477-7525-10-66) contains supplementary material, which is available to authorized users.
DAR and SS are employees of United BioSource Corporation and have research support from Bristol-Myers Squibb (BMS). AJMV is on the BMS advisory board and has been paid honoraria by BMS. PL is a consultant to BMS, has been a member of BMS Speakers Bureau, and has received honoraria from BMS to attend international conferences. PL has undertaken a number of unpaid academic projects with BMS around treatment of melanoma and also this study; which have been or are being submitted for publication. CL has received honoraria from BMS for ipilimumab development. GL is a consultant for GlaxoSmithKline, Genentech, and BMS and has received honoraria from BMS. CHO has consulted for BMS, received honoraria from BMS, and has received an unrestricted grant from BMS for a clinical trial using ipilimumab. MM declares that she has no competing interests. AH is an employee with BMS, holds a leadership position with the Cancer Immunotherapy Consortium, and owns stocks in BMS. SW is an employee with and owns stock in BMS. SK is an employee with, owns stock in, and has research funding from BMS.
DAR participated in data analysis and interpretation and manuscript writing. AJMV participated in data analysis and interpretation and manuscript writing. PL participated in the collection and assembly of data, data analysis and interpretation, and manuscript writing. CL participated in the conception and design and manuscript writing. GL participated in data analysis and interpretation and manuscript writing. CHO participated in the conception and design and manuscript writing. SS participated in manuscript writing and provided project management and administrative support. MM participated in data analysis and interpretation and manuscript writing. AH participated in data analysis and interpretation and manuscript writing. SW participated in conception and design and manuscript writing. SK participated in the conception and design, collection and assembly of data and manuscript writing. All authors read and approved the final manuscript.
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