Shoushtari AN, et al. – This study aspired to ascertain detailed toxic effects and time to treatment failure of patients with melanoma treated with nivo+ipi in a prospective cohort. A 91% incidence of clinically significant immune–related adverse events (AEs) were reported. It led to frequent emergency department visits, hospitalizations, and systemic immunosuppression. As per findings, most patients did not tolerate 4 doses of nivo+ipi.

Methods

• Researchers investigated a cohort of 64 adults with advanced or unresectable melanoma at a single tertiary cancer.
• This cohort was enrolled in an expanded access program of nivo+ipi conducted from December 2014 to January 2016.

Results

• This study incorporated 64 adults with advanced or unresectable melanoma (male to female ratio, 1:1; median [range] age, 56 [22-82] years); 25 patients (39%) received all 4 doses of nivo+ipi, and 31 patients (48%) received no maintenance anti–PD-1 therapy.
• In addition, most who discontinued treatment (n=31 [80%]) stopped because of toxic effects.
• Time to treatment failure was similar between those who did or did not modify therapy for toxic effects, among those patients who were progression free at 12 weeks.
• A clinically significant immune-related AE (median, 2/patient) were observed in fifty-eight patients (91%) , and 46 patients (72%) required systemic steroids.
• For steroid-refractory immune-related Aes, infliximab or mycophenolate was required in 16 patients (25%).
• Moreover, seven patients (11%) developed hyperglycemia, 32 patients (50%) had an emergency department visit, and 23 patients (36%) required a hospital admission related to an immune-related AE.
• In addition, four of 31 patients (13%) who stopped combination therapy early for toxic effects developed a new, clinically significant immune-related AE more than 16 weeks after the last treatment.