Toxicity
Adverse events of any grade occurred in 96.8% of patients in the durvalumab group and 94.9% of patients in the placebo group. Grade 3 or 4 adverse events occurred in 30.5% of patients in the durvalumab group and 26.1% of patients in the placebo group. The most common adverse events in the durvalumab group were cough (35.2%), pneumonitis/radiation pneumonitis (32.8%), fatigue (24.0%) and dyspnoea (22.3%).r
Discontinuation due to adverse events occurred in 15.4% of patients in the durvalumab group and 9.8% of patients in the placebo group. The most frequent adverse events leading to discontinuation of durvalumab and placebo were pneumonitis/radiation pneumonitis (6.1% and 3.9% respectively) and pneumonia (1.1% and 1.3% respectively).r
Pneumonitis or radiation pneumonitis of any grade occurred in 32.8% of patients in the durvalumab group and 23.5% of patients in the placebo group. The incidence of grade 3 or 4 pneumonitis/radiation pneumonitis was 3.4% with durvalumab and 2.1% with placebo.r
Death due to any adverse events occurred in 4.4% of patients in the durvalumab group and 6.4% of patients in the placebo group.r The initial interim analysis listed deaths due to treatment-related adverse events occurred in 7 patients (1.5%) receiving durvalumab (4 with pneumonitis, 1 with each of cardiomyopathy, right ventricular failure, respiratory distress, respiratory failure, increased brain natriuretic peptide and radiation pneumonitis). Death due to treatment-related adverse events occurred in 3 patients (1.3%) receiving placebo.r An update on deaths due to treatment-related adverse events was not included in the OS analysis.r
© N Engl J Med 2018