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

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

Research output: Contribution to journalArticlepeer-review


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)

Original languageEnglish
Pages (from-to)183-196
Number of pages14
JournalQuality of Life Research
Issue number1
StatePublished - Jan 2023

Bibliographical note

Funding Information:
This study was conducted by the ECOG-ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: UG1CA233184, U10CA180794, UG1CA189823, U10CA180821, UG1CA189828, U10CA180820, UG1CA189867, U10CA180868, UG1CA189974, U10CA180888, UG1CA189860, UG1CA189863, UG1CA189953, UG1CA189956, UG1CA189957, UG1CA233180, UG1CA233196, and UG1CA189858. Dr. McLouth’s effort on this manuscript was supported by R25CA122061, P30 CA1777558, and 2KL2TR001996-05A1.

Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Nature Switzerland AG.


  • Adjuvant therapy
  • Interferon
  • Ipilimumab
  • Melanoma
  • Patient-reported outcomes
  • Quality of life

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health


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