Subset analysis of the safety and efficacy of nivolumab in elderly patients with metastatic melanoma
© Freeman and Weber 2015
Published: 4 November 2015
Cancer immunotherapy has generated significant response rates and prolonged survival, particularly in metastatic melanoma, but carries the risk of immune-related adverse events (irAEs) . Treatment of elderly patients with checkpoint inhibition presents a unique challenge as nearly half of all malignancies are diagnosed in patients >65 , and clinical indications for immunotherapy continue to increase. Side effects may be more challenging in older patients given the association of age with comorbidties and reduced functional reserve ; additionally “immunosenescence,” age-related impairment of adaptive and innate immunity, could impair effective checkpoint inhibition .
Retrospective analysis of irAEs and survival outcomes in melanoma patients < 65 compared to those >65 treated with nivolumab.
Data pooled from 148 patients treated with nivolumab plus peptide vaccine or nivolumab alone every two weeks for at least 12 weeks. Frequency, grade, and characteristics of irAEs were analyzed among patients >65 and < 65 years of age. A 12-week landmark survival analysis was then assessed for each group.
Of 148 patients, 52 (35%) were age >65. Most common irAEs among pts < 65 included diarrhea/colitis (30.2%), rash (38.5%), and vitiligo (10.4%). These were also the most common irAEs in pts > 65 (21.2%, 40.4%, and 7.7%, respectively). No statistically significant difference in irAE incidence was seen between groups (p=0.322, 0.966, and 0.805, respectively) and there was no statistically significant OS difference between patients >65 and < 65 (p=0.115). A statistically significant OS benefit was seen in patients < 65 and >65 experiencing any grade of irAE (p=< 0.001 and p=0.033, respectively).
Immune-related adverse events in melanoma patients <65 and >65 treated with nivolumab.
Incidence (%) Age <65
Incidence (%) Age≥65
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