Abstract
We aimed to elucidate predictive factors for the development of immune-related adverse events (iraes) in patients receiving immunotherapies for the management of advanced solid cancers. This retrospective study involved all patients with histologically confirmed metastatic or inoperable melanoma, non-small-cell lung cancer, or renal cell carcinoma receiving immunotherapy at the Cancer Centre of Southeastern Ontario. The type and severity of iraes, as well as potential protective and exacerbating factors, were collected from patient charts. The study included 78 patients receiving ipilimumab (32%), nivolumab (33%), or pembrolizumab (35%). Melanoma, non-small-cell lung cancer, and renal cell carcinoma accounted for 70%, 22%, and 8% of the cancers in the study population. In 41 patients (53%) iraes developed, with multiple iraes developing in 12 patients (15%). In most patients (70%), the iraes were of severity grade 1 or 2. Female sex [adjusted odds ratio (oradj): 0.094; 95% confidence interval (ci): 0.021 to 0.415; p = 0.002] and corticosteroid use before immunotherapy (oradj: 0.143; 95% ci: 0.036 to 0.562; p = 0.005) were found to be associated with a protective effect against iraes. In contrast, a history of autoimmune disease (oradj: 9.55; 95% ci: 1.34 to 68.22; p = 0.025), use of ctla-4 inhibitors (oradj: 6.25; 95% ci: 1.61 to 24.25; p = 0.008), and poor kidney function of grade 3 or greater (oradj: 10.66; 95% ci: 2.41 to 47.12; p = 0.025) were associated with a higher risk of developing iraes. A Hosmer-Lemeshow goodness-of-fit test demonstrated that the logistic regression model was effective at predicting the development of iraes (chi-square: 1.596; df = 7; p = 0.979). Our study highlights several factors that affect the development of iraes in patients receiving immunotherapy. Although future studies are needed to validate the resulting model, findings from the study can help to guide risk stratification, monitoring, and management of iraes in patients given immunotherapy for advanced cancer.
Highlights
Immunomodulation has recently become an important and promising line of therapy for the treatment of advanced melanoma and an increasing number of other cancer types[1]
Non-small-cell lung cancer, and renal cell carcinoma accounted for 70%, 22%, and 8% of the cancers in the study population
Our study highlights several factors that affect the development of iraes in patients receiving immunotherapy
Summary
Immunomodulation has recently become an important and promising line of therapy for the treatment of advanced melanoma and an increasing number of other cancer types[1]. This new line of immunotherapies consists of antibodies that exert their effect by targeting the immune checkpoint inhibitors. The three most common immunotherapies are ipilimumab (ctla-4 inhibitor), nivolumab (PD-1 inhibitor), and pembrolizumab (PD-1 inhibitor). In a landmark clinical trial by Hodi et al.[2], administration of ipilimumab in patients with stage iii or iv melanoma was shown to significantly increase median survival. Pembrolizumab and nivolumab have both been shown to improve overall survival and progression-free survival in patients with metastatic melanoma[3,4]. The PD-1 inhibitors were subsequently shown to improve survival in patients e403
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