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Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial
Source : https://www.lungcancerjournal.info/article/S0169-5002(22)00043-5/fulltext
Approximately one-third of patients with non-small-cell lung cancer (NSCLC) present with stage III disease at diagnosis, many of whom are inoperable [1]. In patients with unresectable, stage III NSCLC, and adequate performance status, the historical standard of care was platinum-based doublet chemotherapy (CT) and radiotherapy (RT), administered either concurrently or sequentially [2].
Conclusion: The risk of imAEs should not deter use of the PACIFIC regimen in eligible patients, as these events are generally well managed through appropriate clinical intervention.
• Source: Lung Cancer
• Conclusion/Relevance: “The risk of imAEs [immune-mediated adverse events] should not deter use of the PACIFIC regimen in eligible patients, as these events are generally well managed through appropriate clinical intervention.”
• In the Phase III PACIFIC trial involving up to 12 months of durvalumab immunotherapy, 25% of patients with unresectable, stage II NSCLC sans disease progression following chemotherapy exhibited imAEs including pneumonitis. Only 3.4%, however, experienced grade3/4 imAEs. Because the PACFIC regimen is standard-of-care, researchers did a post-hoc analysis to take a further look.
• Most events in the current study were of low-grade severity, with few deaths observed. Pneumonitis and thyroid disorder were the most common imAEs. Most patients experienced imAEs within 3 months of starting darvalumab treatment, with imAEs managed with clinical care.
• One limitation of the current study was the exclusion of all-cause pneumonitis and radiotherapy pneumonitis from the study analysis.
• “The findings of this exploratory, post-hoc analysis should be interpreted with caution,” the authors stated. “The association of imAE status with safety is limited by population-size imbalances across the patient subgroups defined by immune-mediated pneumonitis or non-pneumonitis imAE status, as well as imbalances in potentially prognostic baseline factors due to the subgroup definitions being based on post-randomization imAE occurrence.”