Kalicińska Elżbieta, Jabłonowska-Babij Paula, Morawska Marta, Iskierka-Jażdżewska Elżbieta, Drozd-Sokołowska Joanna, Paszkiewicz-Kozik Ewa, Szukalski Łukasz, Strzała Judyta, Gosik Urszula, Dębski Jakub, Andrasiak Iga, Skotny Anna, Jamroziak Krzysztof, Wróbel Tomasz
Clinical Department of Hematology, Cell Therapies and Internal Diseases, Wroclaw Medical University, 50-367 Wroclaw, Poland.
Experimental Hematooncology Department, Medical University of Lublin, 20-059 Lublin, Poland.
Cancers (Basel). 2024 Dec 13;16(24):4168. doi: 10.3390/cancers16244168.
BACKGROUND/OBJECTIVES: Patients with chronic lymphocytic leukemia (CLL) are susceptible to infections that can affect their clinical outcomes.
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).
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.
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 ( = 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, = 0.014; HR 1.73, 95%CI 1.08-2.78, = 0.02; HR 2.13, 95%CI 1.10-4.11, = 0.03, HR 3.58, 95%CI 2.18-5.89, < 0.001, respectively). Relapsed/refractory (R/R) CLL patients treated with R-VEN with pneumonia had worse OS than those without ( < 0.001). In patients treated with O-VEN, median OS did not differ between patients with and without pneumonia ( = 0.45).
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，这会影响其临床结局。
本研究的目的是评估以下内容：（1）在真实世界中接受基于维奈克拉方案治疗的CLL患者的肺炎发病率；（2）无事件生存期（EFS）的危险因素；（3）总生存期（OS）。
这项多中心研究纳入了来自8个中心的322例患者。进行了单变量和多变量分析（MVA），将基于维奈克拉治疗期间肺炎的发生情况和OS作为结局。
最常见的并发症是中性粒细胞减少（59%）。在接受基于维奈克拉方案治疗期间，66例（20%）患者发生肺炎——利妥昔单抗联合维奈克拉（R-VEN）组有50例（23%）患者，奥妥珠单抗联合维奈克拉（O-VEN）组有13例（16%）患者（P = 0.15）。慢性阻塞性肺疾病（COPD）/哮喘、脾肿大、肌酐升高和血红蛋白<8 g/dL是MVA中EFS的危险因素（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，分别）。接受R-VEN治疗且发生肺炎的复发/难治性（R/R）CLL患者的OS比未发生肺炎的患者更差（P < 0.001）。在接受O-VEN治疗的患者中，有肺炎和无肺炎患者的中位OS无差异（P = 0.45）。
我们的真实世界研究表明，维奈克拉治疗期间肺炎的发生率高于注册试验报告的发生率，并且对OS有负面影响，尤其是在接受R-VEN治疗的R/R CLL患者中。中性粒细胞减少不是肺炎的危险因素。
