Incidence And Risk Factors Of Retinopathy In Patients With Melanoma Treated With High Dose Of Interferon Alpha-2b(Hdi).

e21635 Background: Retinopathy is one of the rare side effects of interferon α-2b. It has been observed in the treatment of hepatitis with low or middle dose interferon α-2b, but only a few cases have been reported in the treatment of melanoma with high dose. This study were conducted to elucidate the occurrence frequency and risk factors for retinopathy in Chinese patients(pts) with melanoma who are treated with HDI. Methods: We prospectively analyzed 49 pts with melanoma, who went through HDI therapy. Their visual acuity and visual field were measured, and fundus assessments were made at baseline, at 2, 4 weeks post the commencement of induction therapy, and at every 12 weeks in the maintenance treatment period. Results: 37 pts (76%) developed retinopathy, which were all reversible mild changes, including cotton wool spots and retinal hemorrhage. Cotton-wool spots were observed in 18 pts(49%), retinal hemorrhage was observed in 7 pts(19%), and the retinal hemorrhage with cotton-wool spots was found in 12 cases(32%). The median (P25-P75) time to develop the retinopathy was 4(2-6) weeks. All pts had no symptom, except for one patient who developed blurred vision. 5 pts(10%) had diabetes mellitus, 8 (16%) had hypertension and 3(6%) had both diabetes and hypertension. All of these pts developed retinopathy, but there was no statistically significant difference in pts with complications by diabetes and/or hypertension compared with those without these issues(diabetes vs without diabetes:P = 0.427; hypertension vs without hypertension:P = 0.19; diabetes and hypertension vs without diabetes or hypertension:P = 0.545). Comparison of the clinical backgrounds between the pts with retinopathy and those without showed no significant differences in age, gender, primary site, stage, ulceration present,gene mutation, lactate dehydrogenase level, white blood cell count, platelet count, hemoglobin level, blood lipid level or thyroid function. Conclusions: HDI therapy in pts with melanoma may induced mild retinopathy, however it is not necessary to discontinue the therapy. Retinopathy occurred more frequently in pts with diabetes and/or hypertension, and those pts may be required follow-up more carefully. Clinical trial information: NCT02702973.