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Efficacy and safety of immune checkpoint inhibitors (ICIs) in extensive-stage small cell lung cancer (SCLC)

机译:免疫检查点抑制剂(ICIS)在广泛阶段小细胞肺癌(SCLC)中的疗效和安全性

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Background To evaluate the efficacy and safety of an immune checkpoint inhibitor (ICI) combined with chemotherapy in patients with advanced SCLC. Methods We searched published randomized-controlled trials (RCTs) to compare the effect of ICIs combined with chemotherapy and chemotherapy alone on SCLC. The extracted data included the number of people who achieved an objective response rate (ORR), the disease control rate (DCR), the hazard ratio (HR) of progression-free survival (PFS), and the overall survival (OS) with 95% confidence intervals (95% CI). Results Six RCTs involving 2477 patients were included. Compared with chemotherapy alone, patients receiving an ICI combined with chemotherapy had a significantly longer PFS (HR, 0.91; 95% CI 0.88-0.95,p < 0.00001) and OS (HR 0.92; 95% CI 0.89-0.96,p = 0.0001). The ORR increased, but the difference was not statistically significant (RR 1.05; 95% CI 0.99-1.12,p = 0.13). There was no significant difference in the DCR between the two treatment regimens; however, in patients treated with an ICI, fatigue, rashes, diarrhea, and elevated aminotransferase enzymes were significantly increased (p < 0.05). Conclusion ICI combined with chemotherapy is superior to chemotherapy alone with respect to PFS and OS in patients with advanced SCLC.
机译:背景:评估免疫检查点抑制剂(ICI)联合化疗治疗晚期小细胞肺癌的疗效和安全性。方法检索已发表的随机对照试验(RCT),比较ICIs联合化疗和单纯化疗对小细胞肺癌的疗效。提取的数据包括达到客观缓解率(ORR)、疾病控制率(DCR)、无进展生存率(PFS)的危险比(HR)以及95%置信区间(95%CI)的总生存率(OS)的人数。结果共纳入6项随机对照试验,涉及2477例患者。与单纯化疗相比,接受ICI联合化疗的患者的PFS(HR,0.91;95%可信区间0.88-0.95,p<0.00001)和OS(HR 0.92;95%可信区间0.89-0.96,p=0.0001)显著延长。ORR增加,但差异无统计学意义(RR 1.05;95%可信区间0.99-1.12,p=0.13)。两种治疗方案的DCR无显著差异;然而,在接受ICI治疗的患者中,疲劳、皮疹、腹泻和转氨酶升高显著增加(p<0.05)。结论ICI联合化疗治疗晚期小细胞肺癌在PFS和OS方面优于单纯化疗。

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