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  • Title: New and Worsening Long-term Immune-Related Adverse Events with PD-1/PD-L1 Pathway Agents in Patients with Cancer.
    Author: Hall KH, Liu Y, Jiang C, Harvey RD.
    Journal: Pharmacotherapy; 2020 Feb; 40(2):133-141. PubMed ID: 31863604.
    Abstract:
    STUDY OBJECTIVES: Immune checkpoint inhibitors have produced durable responses across a variety of cancers. Although programmed cell death protein 1 (PD-1) and its ligand (PD-L1) inhibitors activate T cells against tumor cells, they may also cause autoimmune-like toxicities termed immune-related adverse events (irAEs). Although much is known regarding irAEs that occur early during treatment, data on the long-term toxicity profile of these agents are more limited. Our primary objective was to evaluate the frequency of patients receiving anti-PD-1/PD-L1 therapy for at least 6 continuous months who experienced new or worsening irAEs requiring clinical interventions. Secondary objectives included assessment of other factors associated with clinically significant irAEs after at least 6 months of therapy. DESIGN: Retrospective chart review. SETTING: Large university-affiliated National Cancer Institute-designated comprehensive cancer center. PATIENTS: A total of 159 adults diagnosed with any malignancy who received a PD-1/PD-L1 inhibitor-nivolumab, pembrolizumab, or atezolizumab-as monotherapy or with concurrent cytotoxic agents, for at least 6 months, between January 1, 2014, and September 1, 2017. MEASUREMENTS AND MAIN RESULTS: We collected information on the incidence and timing of irAEs, along with patient demographics and other treatment outcomes. Thirty-eight patients (24%) experienced clinically significant, new, or worsening irAEs after 6 months of treatment with anti-PD-1/PD-L1 therapy. Hypothyroidism was the most common irAE experienced (20 patients [12.6%]), followed by pneumonitis (5 patients [3%]); 2 patients died due to pneumonitis. Four patients (2.5%) had a deepened disease response beyond 6 months of treatment. CONCLUSION: Our results revealed that a significant proportion of patients continue to experience irAEs with long-term use of PD-1/PD-L1 inhibitors. These results further contribute to the risk-benefit understanding of chronic PD-1/PD-L1 antagonism and support discontinuation of these agents following deepest response.
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