Abstract 3641: Use of adjuvant interferon alfa-2b or ipilimumab 10 mg/kg for high-risk patients with melanoma, and associated adverse events and duration of therapy

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Abstract OBJECTIVE: Adjuvant systemic therapy with interferon alfa-2b (IFN) or ipilimumab 10 mg/kg (IPI10) has been the standard for high-risk patients with melanoma who have undergone surgery; however, a high proportion of patients remain untreated. This analysis examines the adverse events (AEs) and duration of therapy (DoT) associated with IFN or IPI10. METHODS: A retrospective cohort study was conducted among each of the four US healthcare databases: OptumInsight, IMS PharMetrics, Truven Commercial, and Truven Medicare Supplemental. Patients receiving melanoma-related surgery (lymph node dissection) from July 1, 2006, to September 30, 2016, were identified. The study estimated the incidence rate (IR) per patient per year of AEs that commonly occur with IFN or IPI10 across different DoT levels among patients with melanoma following surgery. RESULTS: Of 46,401 eligible patients with melanoma surgery claims, 2423 (5%) were treated: 2316 with IFN and 107 with IPI10. Mean age was 51.7 years (60.5% male), and mean (standard deviation) Charlson comorbidity index score was 6.6 (2.8) and 7.5 (2.5) for patients prescribed IFN or IPI10, respectively. The DoT (median, mean (SD)) for IFN was 142, 182 (162) days and for IPI10 was 84, 73 (26) days. Similarly, the number of prescriptions (median, mean (SD)) for IFN were 20, 26 (28) and for IPI10 were 4, 3 (1). The overall AE IR per year was 4.4 in patients receiving IFN and 4.9 for those receiving IPI10. Among patients receiving IFN, the most common AEs were hepatitis, nausea, and fatigue (IRs: 0.92, 0.67, and 0.66, respectively). The most common AEs among IPI10-treated patients were fatigue, rash, nausea, and diarrhea (IRs of 0.95, 0.71, 0.66, and 0.63, respectively). AE rates were greater in patients with low DoT compared with those with a high DoT for most AEs in both IFN and IPI10 cohorts. CONCLUSION: Only 5% of high-risk patients with melanoma following lymph node dissection surgery were treated with adjuvant IPI10 or IFN, while the remaining were untreated. Patients treated with IPI10 or IFN had high AE rates impacting their ability to remain on therapy. Newer adjuvant treatments with more favorable AEs and DoT profiles are urgently needed for high-risk patients with melanoma. Disclosure: This research was funded by Bristol-Myers Squibb. Citation Format: Ahmad Tarhini, Komal Gupte-Singh, Min You, Amit Gupta, Le Trong Kim, Sumati Rao. Use of adjuvant interferon alfa-2b or ipilimumab 10 mg/kg for high-risk patients with melanoma, and associated adverse events and duration of therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 3641.