Introduction: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.Methods: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.Results: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.Conclusions:Despite our analysis confirming the manageable safety profile of chemoimmunotherapy, this remains an issue to be further investigated.
引言:目前,广泛期小细胞肺癌患者的预后较差。然而,一线化疗的高缓解率以及免疫检查点抑制剂的加入显著改善了这些患者的治疗结局。本研究旨在比较接受一线免疫检查点抑制剂联合化疗与仅接受化疗的广泛期小细胞肺癌患者之间治疗相关不良事件的差异。 方法:检索2008年6月15日至2024年6月30日期间发表的所有关于初治广泛期小细胞肺癌患者使用免疫检查点抑制剂联合全身化疗与单纯化疗的三期临床试验。 结果:研究共纳入26种不良事件,分为10个类别,总计43,391例观察数据(免疫治疗组22,643例,安慰剂组20,748例)及9,831起不良事件。分析显示,与单纯化疗相比,接受免疫检查点抑制剂联合化疗的患者血液学事件发生率在统计学上显著增加。相反,单纯化疗组患者更常出现如高血压等血压异常事件。 结论:尽管分析证实了化疗联合免疫治疗的安全性总体可控,但这仍是需要进一步研究的问题。