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27-08-2022

Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III–IV melanoma in phase III trial E1609

Auteurs: Laurie E. McLouth, Yue Zheng, Stephanie Smith, F. Stephen Hodi, Uma N. Rao, Gary I. Cohen, Thomas T. Amatruda, Shaker R. Dakhil, Brendan D. Curti, Ibrahim Nakhoul, Sreenivasa R. Chandana, Charles L. Bane, David E. Marinier, Sandra J. Lee, Vernon K. Sondak, John M. Kirkwood, Ahmad A. Tarhini, Lynne I. Wagner

Gepubliceerd in: Quality of Life Research | Uitgave 1/2023

Abstract

Purpose

Trial E1609 demonstrated superior overall survival with ipilimumab 3 mg/kg (ipi3) compared to high-dose interferon (HDI) for patients with resected high-risk melanoma. To inform treatment tolerability, we compared health-related quality of life (HRQoL), gastrointestinal (GI), and treatment-specific physical and cognitive/emotional symptoms. We also compared treatment-specific concerns between all arms.

Methods

We assessed HRQoL using the Functional Assessment of Cancer Therapy-General, physical and cognitive/emotional concerns using the FACT-Biologic Response Modifier subscale, and GI symptoms with the Functional Assessment of Chronic Illness Therapy-Diarrhea subscale pre-treatment and every 3 months. The primary outcome was the difference in HRQoL at 3 months between ipi3/ipi10 vs. HDI.

Results

549 patients (n = 158 ipi3; n = 191 ipi10; n = 200 HDI) were analyzed. 3-month completion was 58.7%. Compared to HDI, ipilimumab patients reported better HRQoL (ipi3 = 87.5 ± 14.6 vs. HDI = 74.7 ± 15.4, p < .001; ipi10 = 84.9 ± 16.5 vs. HDI, p < .001) and fewer physical (ipi3 = 22.3 ± 4.6 vs. HDI = 17.1 ± 5.4, p < .001; ipi10 = 21.8 ± 5.0 vs. HDI p < .001) and cognitive/emotional (ipi3 = 18.6 ± 4.4 vs. HDI = 15.0 ± 5.3, p < .001; ipi10 = 17.7 ± 4.8 vs. HDI p < .001) concerns, but worse GI symptoms (ipi3 = 40.8 ± 5.0 vs. HDI = 42.2 ± 2.9, p = .011; ipi10 = 39.5 ± 7.0 vs. HDI, p < .001). Fewer ipilimumab patients reported worsening treatment-specific concerns (e.g., 52% of ipi3 and 58% of ipi10 reported worsening fatigue vs. 82% HDI, p’s < .001).

Conclusion

PROs demonstrated less toxicity of ipi3 compared to HDI and ipi10. Priorities for symptom management among patients receiving ipilimumab include GI toxicities, fatigue, weakness, appetite loss, arthralgia, and depression.

Trial Registration: NCT01274338, January 11, 2011 (first posted date) https://clinicaltrials.gov/ct2/show/NCT01274338?term=NCT01274338&draw=2&rank=1.

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Titel: Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III–IV melanoma in phase III trial E1609
Auteurs: Laurie E. McLouth
Yue Zheng
Stephanie Smith
F. Stephen Hodi
Uma N. Rao
Gary I. Cohen
Thomas T. Amatruda
Shaker R. Dakhil
Brendan D. Curti
Ibrahim Nakhoul
Sreenivasa R. Chandana
Charles L. Bane
David E. Marinier
Sandra J. Lee
Vernon K. Sondak
John M. Kirkwood
Ahmad A. Tarhini
Lynne I. Wagner
Publicatiedatum: 27-08-2022
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 1/2023
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-022-03226-8

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Abstract

Purpose

Methods

Results

Conclusion

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