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

Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment
Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment
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
1477-7525
1-8
Revicki, Dennis A.
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van den Eertwegh, Alfons J.M.
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Lorigan, Paul
a996ae96-91af-4ba9-8b66-be50cca03809
Lebbe, Celeste
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Linette, Gerald
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Ottensmeier, Christian H.
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Safikhani, Shima
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Messina, Marianne
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Hoos, Axel
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Wagner, Samuel
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Kotapati, Srividya
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Revicki, Dennis A.
57ace06d-e1d0-4d3d-ab43-606c3f54c83a
van den Eertwegh, Alfons J.M.
784bf2f2-7c39-4a1f-8432-3641b5785f3e
Lorigan, Paul
a996ae96-91af-4ba9-8b66-be50cca03809
Lebbe, Celeste
7aaa77be-2a6b-4261-a958-9d3ce142ca32
Linette, Gerald
a908d31f-6538-4e41-8812-05ed9ef073fe
Ottensmeier, Christian H.
42b8a398-baac-4843-a3d6-056225675797
Safikhani, Shima
35a88725-429c-40b2-8228-296224d6028b
Messina, Marianne
876fd319-a22f-4c08-93a9-4ce6a990dcd9
Hoos, Axel
618b25dd-8bfd-4e66-bcc6-01359b52f637
Wagner, Samuel
2aad4ce8-ccf2-403f-8278-90d747c93a37
Kotapati, Srividya
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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 and Kotapati, Srividya (2012) Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health and Quality of Life Outcomes, 10 (66), 1-8. (doi:10.1186/1477-7525-10-66). (PMID:22694829)

Record type: Article

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

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Accepted/In Press date: 17 May 2012
Published date: 12 June 2012
Organisations: Cancer Sciences

Identifiers

Local EPrints ID: 396352
URI: https://eprints.soton.ac.uk/id/eprint/396352
ISSN: 1477-7525
PURE UUID: df8b784e-5606-4782-9aff-7ebfa1fe607a

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Date deposited: 08 Jun 2016 15:35
Last modified: 28 Aug 2019 18:20

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Contributors

Author: Dennis A. Revicki
Author: Alfons J.M. van den Eertwegh
Author: Paul Lorigan
Author: Celeste Lebbe
Author: Gerald Linette
Author: Shima Safikhani
Author: Marianne Messina
Author: Axel Hoos
Author: Samuel Wagner
Author: Srividya Kotapati

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