1070P Adjuvant treatment for melanoma in clinical practice: Trial versus reality

Abstract

tested ipilimumab 3 mg/kg (ipi3) and 10 mg/kg (ipi10) versus high-dose IFN-a (HDI) and S1404 (N¼1207) that tested pembrolizumab versus patient/physician choice of ipi10 or HDI. We sought to estimate the incidence of GSL as reported by trial investigators in the combined datasets utilizing descriptive statistics as summarized in the table, along with the corresponding CTCAE grades.Results: Among 2878 patients treated with ICIs or with HDI in E1609 and S1404, 523 were treated with ipi3, 932 with ipi10, 640 with pembrolizumab and 783 with HDI. A total of 11 GSL cases were reported. Cases were reported with ipi10, followed by pembrolizumab, ipi3 and HDI, respectively. Organs involved included skin and subcutaneous tissue (granuloma annulare, granulomatous dermatitis), eye (ocular sarcoidosis), lymph nodes (noncaseating granulomatous lymphadenitis), lung and mediastinal lymph nodes (sarcoidosis, granulomatous inflammation).Conclusions: Granulomatous and sarcoid-like lesions (GSL) following adjuvant anti-CTLA4 and anti-PD1 antibody therapy in high-risk melanoma were reported rarely. Reported cases ranged in grade from 1-3 and appeared manageable. Careful attention to these events and their reporting would be essential to better guide practice and management guidelines.