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

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.