Background/Objectives: Patients with chronic lymphocytic leukemia (CLL) are susceptible to infections that can affect their clinical outcomes. Aims: The aims of this study were to assess the following: (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). Methods: This multicenter study included 322 patients from eight centers. Univariable and multivariable analyses (MVA) were performed, with the development of pneumonia during venetoclax-based treatment and OS as outcomes. Results: The most common complication was neutropenia (59%). During treatment with venetoclax-based regimens, 66 (20%) patients developed pneumonia—50 (23%) patients in the rituximab-plus-venetoclax (R-VEN) group and 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 (HR = 2.08, 95%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). Conclusions: Our 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 who are treated with R-VEN. Neutropenia is not a risk factor for pneumonia.
背景/目的：慢性淋巴细胞白血病（CLL）患者易发生感染，这可能影响其临床结局。本研究旨在评估以下内容：(1) 真实世界中使用维奈托克为基础方案治疗的CLL患者中肺炎的发生率，(2) 无事件生存期（EFS）的风险因素，以及(3) 总生存期（OS）。方法：这项多中心研究纳入了来自八个中心的322例患者。进行了单变量和多变量分析（MVA），以维奈托克为基础治疗期间发生肺炎和OS作为结局指标。结果：最常见的并发症是中性粒细胞减少症（59%）。在维奈托克为基础方案治疗期间，66例（20%）患者发生肺炎——其中利妥昔单抗联合维奈托克（R-VEN）组有50例（23%），奥妥珠单抗联合维奈托克（O-VEN）组有13例（16%）（p=0.15）。在多变量分析中，慢性阻塞性肺疾病（COPD）/哮喘、脾肿大、肌酐升高和贫血（<8 g/dL）是EFS的风险因素（风险比[HR]分别为2.08，95%置信区间[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）。在R-VEN治疗的复发/难治性（R/R）CLL患者中，发生肺炎者的OS比未发生者更差（p<0.001）。在O-VEN治疗的患者中，发生肺炎与未发生肺炎患者的中位OS无差异（p=0.45）。结论：我们的真实世界研究表明，维奈托克治疗期间肺炎的发生率高于注册试验报告，并对OS产生负面影响，尤其是在接受R-VEN治疗的R/R CLL患者中。中性粒细胞减少症并非肺炎的风险因素。
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