TY - JOUR
T1 - 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
AU - McLouth, Laurie E.
AU - Zheng, Yue
AU - Smith, Stephanie
AU - Hodi, F. Stephen
AU - Rao, Uma N.
AU - Cohen, Gary I.
AU - Amatruda, Thomas T.
AU - Dakhil, Shaker R.
AU - Curti, Brendan D.
AU - Nakhoul, Ibrahim
AU - Chandana, Sreenivasa R.
AU - Bane, Charles L.
AU - Marinier, David E.
AU - Lee, Sandra J.
AU - Sondak, Vernon K.
AU - Kirkwood, John M.
AU - Tarhini, Ahmad A.
AU - Wagner, Lynne I.
N1 - Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Nature Switzerland AG.
PY - 2023/1
Y1 - 2023/1
N2 - 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.
AB - 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.
KW - Adjuvant therapy
KW - Interferon
KW - Ipilimumab
KW - Melanoma
KW - Patient-reported outcomes
KW - Quality of life
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U2 - 10.1007/s11136-022-03226-8
DO - 10.1007/s11136-022-03226-8
M3 - Article
C2 - 36029412
AN - SCOPUS:85136694546
SN - 0962-9343
VL - 32
SP - 183
EP - 196
JO - Quality of Life Research
JF - Quality of Life Research
IS - 1
ER -
