Cancer Center, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong An Road, Xi Cheng District, Beijing, 100050, China.
Department of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong An Road, Xi Cheng District, Beijing, 100050, China.
J Cancer Res Clin Oncol. 2021 Feb;147(2):593-606. doi: 10.1007/s00432-020-03362-z. Epub 2020 Aug 27.
To evaluate the efficacy and safety of an immune checkpoint inhibitor (ICI) combined with chemotherapy in patients with advanced SCLC.
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).
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).
ICI combined with chemotherapy is superior to chemotherapy alone with respect to PFS and OS in patients with advanced SCLC.
评估免疫检查点抑制剂（ICI）联合化疗治疗晚期小细胞肺癌（SCLC）患者的疗效和安全性。
我们检索了已发表的随机对照试验（RCT），比较了ICI 联合化疗与单纯化疗对 SCLC 的疗效。提取的数据包括客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）和总生存期（OS）的进展风险比（HR），以及 95%置信区间（95%CI）。
纳入了 6 项 RCT 共 2477 例患者。与单纯化疗相比，ICI 联合化疗组患者的 PFS（HR 0.91；95%CI 0.88-0.95，p<0.00001）和 OS（HR 0.92；95%CI 0.89-0.96，p=0.0001）均显著延长。ORR 有所提高，但差异无统计学意义（RR 1.05；95%CI 0.99-1.12，p=0.13）。两种治疗方案的 DCR 无显著差异；然而，ICI 治疗组的乏力、皮疹、腹泻和转氨酶升高明显增加（p<0.05）。
ICI 联合化疗在晚期 SCLC 患者中较单纯化疗具有更好的 PFS 和 OS。
