Abstract

AbstractBackgroundPatients with chronic lymphocytic leukemia (CLL) are susceptible to infections that can affect their clinical outcomes.AimsTo assess: (1) the incidence of pneumonia in CLL patients treated with venetoclax‐based regimens in a real‐world setting, (2) the risk factors for event‐free survival (EFS), and (3) overall survival (OS).MethodsThis multicenter study included 322 patients from eight centers. Univariable and multivariable analyses (MVA) were performed, having the development of pneumonia during venetoclax‐based treatment and OS as outcomes.ResultsThe most common complication was neutropenia (59%). During treatment with venetoclax‐based regimens, 66 (20%) of patients developed pneumonia: 50 (23%) patients in the rituximab plus venetoclax (R‐VEN) group, 13 (16%) patients in the obinutuzumab plus venetoclax (O‐VEN) group (p = 0.15). Chronic obstructive pulmonary disease (COPD)/asthma, splenomegaly, elevated creatinine, and anemia <8 g/dL were the risk factors for EFS in MVA (hazard ratio [HR] = 2.08, 95% confidence interval [CI], 1.16–3.74, p = 0.014; HR 1.73, 95% CI, 1.08–2.78, p = 0.02; HR 2.13, 95% CI, 1.10–4.11, p = 0.03, HR 3.58, 95% CI, 2.18–5.89, p < 0.001, respectively). Relapsed/refractory (R/R) CLL patients treated with R‐VEN with pneumonia had worse OS than those without (p < 0.001). In patients treated with O‐VEN, median OS did not differ between patients with and without pneumonia (p = 0.45).ConclusionsOur real‐world study showed that pneumonia during venetoclax treatment occurs more frequently than reported in registration trials and has a negative impact on OS, especially in patients with R/R CLL treated with R‐VEN. Neutropenia is not a risk factor for pneumonia.

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