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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Health and Quality of Life Outcomes 1/2012

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

Zeitschrift:
Health and Quality of Life Outcomes > Ausgabe 1/2012
Autoren:
Dennis A Revicki, Alfons JM van den Eertwegh, Paul Lorigan, Celeste Lebbe, Gerald Linette, Christian H Ottensmeier, Shima Safikhani, Marianne Messina, Axel Hoos, Samuel Wagner, Srividya Kotapati
Wichtige Hinweise

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.

Competing interests

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.

Authors' contributions

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.

Abstract

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
Zusatzmaterial
Additional file 1: Methodology for comparison with other melanoma clinical trials. A systematic search of review articles and clinical trial articles was conducted in order to compare the HRQL findings from the ipilimumab studies to other published clinical trials in advanced melanoma that included the EORTC QLQ-C30. Microsoft Word document file name: HRQL Melanoma Manuscript Appendix_HQLO_final.doc. (DOC 132 KB)
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Additional file 2: Figure A1. Baseline to endpoint changes in EORTC QLQ-C30 function and global health scores for advanced melanoma studies. (PDF 15 KB)
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Additional file 3: Figure A2. Baseline to endpoint changes in EORTC QLQ-C30 symptom scores for advanced melanoma studies. (PDF 15 KB)
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Authors’ original file for figure 1
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Authors’ original file for figure 2
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Authors’ original file for figure 3
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Authors’ original file for figure 4
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