Department of Medical Oncology, Changzheng Hospital, Second Military Medical University, Shanghai, 200003, China.
National Chiral Pharmaceutical Engineering Technology Research Center, Linyi, 276006, Shandong, China.
Int J Colorectal Dis. 2020 Aug;35(8):1567-1574. doi: 10.1007/s00384-020-03606-x. Epub 2020 May 11.
To compare the efficacy and safety profile of S-1-based versus non-S-1-based chemotherapy as first-line treatment in mCRC.
Relevant randomized controlled trials (RCTs) were obtained from PubMed, Embase, and Ovid databases and the Cochrane library from database set up in May 2018. The RCTs of S-1-based monotherapy or combination therapy as first-line treatment were selected. The impact of S-1-based chemotherapy on progression-free survival (PFS) and overall survival (OS) was assessed by pooling data via RevMan 5.3.
Meta-analysis of 10 RCTs showed that S-1-based chemotherapy significantly improved PFS (HR 0.90, 95% CI 0.84-0.97, P = 0.006). In subgroup analysis, there was a statistically significant increase in PFS when S-1-based chemotherapy was compared with 5-FU-based (HR 0.92, 95% CI 0.84-1.00, P = 0.04) or capecitabine-based chemotherapy (HR 0.85, 95% CI 0.73-0.99, P = 0.04). The meta-analysis of OS (HR 0.95, 95% CI 0.86-1.05, P = 0.36), overall response rate (ORR) (HR 0.99, 95% CI 0.84-1.17, P = 0.90), and disease control rate (DCR) (HR 1.61, 95% CI 0.87-3.00, P = 0.13) showed no statistical significance between S-1-based and non-S-1-based chemotherapy. The statistically significant differences in the meta-analysis indicated less incidence of graded 3-4 leucopenia (OR = 0.30, 95% CI 0.13-0.71, P = 0.006) and hand-foot syndrome (HFS) (OR = 0.24, 95% CI 0.10-0.58, P = 0.001) in the S-1-based chemotherapy, and there was no statistically significant difference for other adverse events.
S-1-based chemotherapy in mono or combined therapy was an attractive alternative to standard first-line regimen for patients of mCRC.
比较 S-1 为基础的化疗与非 S-1 为基础的化疗作为 mCRC 一线治疗的疗效和安全性。
从 PubMed、Embase 和 Ovid 数据库以及 Cochrane 图书馆中检索到相关的随机对照试验（RCTs），这些 RCTs 均为 S-1 为基础的单药或联合治疗作为一线治疗的研究。通过 RevMan 5.3 汇总数据评估 S-1 为基础的化疗对无进展生存期（PFS）和总生存期（OS）的影响。
对 10 项 RCT 的荟萃分析显示，S-1 为基础的化疗可显著改善 PFS（HR 0.90，95%CI 0.84-0.97，P=0.006）。在亚组分析中，与 5-FU 为基础（HR 0.92，95%CI 0.84-1.00，P=0.04）或卡培他滨为基础的化疗（HR 0.85，95%CI 0.73-0.99，P=0.04）相比，S-1 为基础的化疗可显著增加 PFS。OS 的荟萃分析（HR 0.95，95%CI 0.86-1.05，P=0.36）、总缓解率（ORR）（HR 0.99，95%CI 0.84-1.17，P=0.90）和疾病控制率（DCR）（HR 1.61，95%CI 0.87-3.00，P=0.13）在 S-1 为基础的化疗与非 S-1 为基础的化疗之间无统计学意义。荟萃分析中的统计学显著差异表明，S-1 为基础的化疗组 3-4 级白细胞减少症（OR=0.30，95%CI 0.13-0.71，P=0.006）和手足综合征（HFS）（OR=0.24，95%CI 0.10-0.58，P=0.001）的发生率较低，而其他不良反应的发生率则无统计学意义。
S-1 为基础的化疗在单药或联合治疗中是 mCRC 患者标准一线治疗方案的一个有吸引力的替代方案。
