P8.09 - Case series of thyroid dysfunction induced by nivolumab (anti-PD-1; ONO-4538)

Abstract

ABSTRACT Background: Nivolumab, a PD1-specific monoclonal antibody, was approved in Japan on July 2014 for patients with unresectable or metastatic melanoma. Patients: Nivolumab at 2 mg/kg every 3 weeks were initiated to 18 patients with unresectable or metastatic melanoma at University of Tsukuba Hospital. The median age was 71 (range, 39–80) and male:female ratio was 8:10. Of those, 15 patients had primary site at skin and the other 3 had at mucosa. Most of the patients was performance status (PS) score 0 or 1, except 1 patient with PS score 2. Results: Seventeen adverse events (AE) were recorded. Most common AE was thyroid dysfunction and observed in 5 (28%); hyperthyroidism in 2 and hypothyroidism in 3. Whereas no one with hyperthyroidism required treatment, 2 out of 3 with hypothyroidism were symptomatic, such as fatigue and gain weight. However, their symptoms were recovered by replacement of thyroid hormone. No patient required discontinuation of nivolumab due to AEs. Conclusion: According to our study population, using nivolumab was generally safe. Because most of AEs were mild and were manageable, nivolumab seems to be safer than Ipilimumab. However, we should keep in mind that nivolumab might induce thyroid dysfunction. Patients with symptomatic hypothyroidism required hormone replacement therapy.