Vitale Elsa, Rizzo Alessandro, Maistrello Lorenza, Guven Deniz Can, Cauli Omar, Galetta Domenico, Longo Vito
Medical Thoracic Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II", 70124 Bari, Italy.
Struttura S.S.D.C.O.r.O., Bed Management Presa in Carico, TDM, IRCCS Istituto Tumori "Giovanni Paolo II", 70124 Bari, Italy.
Cancers (Basel). 2025 May 5;17(9):1571. doi: 10.3390/cancers17091571.
Nowadays the prognosis of extended stage (ES) small cell lung cancer (SCLC) patients is poor. However, a high response rate to first-line chemotherapy (CT) and the addition of immune checkpoint inhibitors (ICIs) have notably ameliorated the outcome of these patients. The aim of our study is to compare treatment-related adverse events (TRAEs) between ES- SCLC patients receiving first-line ICIs adding CT and those receiving only CT. All phase III clinical trials published between 15 June 2008, and 30 June 2024, likenessing ICIs adding systemic CT and only CT in treatment-naïve ES-SCLC patients were retrieved. Twenty-six types of adverse events were included, grouped into ten categories, for a total of 43,391 observations (observations in immune group n = 22,643 and in placebo group n = 20,748) and 9831 events. Our analysis suggested a statistically significant increase in hematological events in patients receiving ICIs plus CT compared with CT alone. Conversely, blood pressure alterations such as hypertension were more frequent in patients treated with CT alone. Despite our analysis confirming the manageable safety profile of chemoimmunotherapy, this remains an issue to be further investigated.
目前,广泛期(ES)小细胞肺癌(SCLC)患者的预后较差。然而,对一线化疗(CT)的高反应率以及免疫检查点抑制剂(ICI)的加入显著改善了这些患者的预后。我们研究的目的是比较接受一线ICI联合CT的ES-SCLC患者与仅接受CT的患者之间的治疗相关不良事件(TRAE)。检索了2008年6月15日至2024年6月30日期间发表的所有III期临床试验,这些试验比较了初治ES-SCLC患者中ICI联合全身CT与仅CT的疗效。纳入了26种不良事件,分为十类,共有43391条观察数据(免疫组n = 22643,安慰剂组n = 20748)和9831起事件。我们的分析表明,与单独使用CT相比,接受ICI加CT的患者血液学事件在统计学上显著增加。相反,单独使用CT治疗的患者中,高血压等血压改变更为常见。尽管我们的分析证实了化疗免疫疗法具有可控的安全性,但这仍是一个有待进一步研究的问题。