Dept. of Clinical Pharmacy, The Third Hospital of Mianyang, Mianyang, Sichuan, China.
Dept. of Clinical Pharmacy, The Second Affiliated Hospital of Third Military Medical University, Chongqing, China.
PLoS One. 2018 Mar 21;13(3):e0193814. doi: 10.1371/journal.pone.0193814. eCollection 2018.
To evaluate the efficacy and safety of gemcitabine (GEM) at 30 min standard-dose infusion (30 min-SDI) compared with prolonged low-dose infusion (P-LDI) in patients with advanced non-small-cell lung cancer (NSCLC).
Electronic databases including Pubmed, EMbase, Cochrane Library, CNKI, CBM, and VIP were searched using keywords "GEM", "P-LDI", and "NSCLC". Review Manager 5.3 was used to perform the meta-analysis. Primary endpoints were overall response rate (ORR) and 1-year survival rate (1-year SR). Secondary endpoints were grade 3/4 hematotoxicity and nausea/vomiting. In association. GRADE quality of evidence system was used to assess the results of meta-analysis.
Six randomized controlled trials (RCTs) with a total of 637 patients were included and no statistical heterogeneity was found among the studies. The results showed that P-LDI was superior in ORR (RD = 0.09, 95% CI: 0.02 to 0.16, P = 0.02), but had a similar 1-year SR (RD = 0.05, 95% CI: -0.02 to 0.12, P = 0.18) as compared with 30 min-SDI. For grade 3/4 adverse events, there was no significant difference in anemia (RD = 0.02, 95% CI: -0.01 to 0.04, P = 0.27) and nausea/vomiting (RD = 0.01, 95% CI: -0.04 to 0.06, P = 0.64) between the two treatments. However, patients with P-LDI experienced less leukopenia (RD = -0.08, 95% CI: -0.15 to -0.01, P = 0.03) and thrombocytopenia ((RD = -0.05, 95% CI: -0.09 to -0.01, P = 0.006). The GRADE profile showed that the included RCTs had low quality of evidences.
P-LDI was superior in terms of ORR, experienced less grade 3/4 thrombocytopenia and leukopenia compared with 30 min-SDI, and could be a viable treatment option for advanced NSCLC. However, the results need to be further verified by high quality trials and large samples owing to the low quality of evidences.
评估吉西他滨(GEM) 30 分钟标准剂量输注(30 min-SDI)与延长低剂量输注(P-LDI)在晚期非小细胞肺癌(NSCLC)患者中的疗效和安全性。
使用关键词“GEM”、“P-LDI”和“NSCLC”,在电子数据库包括 Pubmed、EMbase、Cochrane Library、CNKI、CBM 和 VIP 中进行检索。使用 Review Manager 5.3 进行荟萃分析。主要终点为总缓解率(ORR)和 1 年生存率(1-year SR)。次要终点为 3/4 级血液学毒性和恶心/呕吐。使用 GRADE 质量证据系统评估荟萃分析结果。
纳入了 6 项随机对照试验(RCTs),共 637 名患者,研究之间无统计学异质性。结果表明,P-LDI 在 ORR 方面更优(RD=0.09,95%CI:0.02 至 0.16,P=0.02),但 1 年 SR 与 30 min-SDI 相似(RD=0.05,95%CI:-0.02 至 0.12,P=0.18)。对于 3/4 级不良事件,贫血(RD=0.02,95%CI:-0.01 至 0.04,P=0.27)和恶心/呕吐(RD=0.01,95%CI:-0.04 至 0.06,P=0.64)在两种治疗方法之间无显著差异。然而,P-LDI 组患者白细胞减少症(RD=-0.08,95%CI:-0.15 至 -0.01,P=0.03)和血小板减少症(RD=-0.05,95%CI:-0.09 至 -0.01,P=0.006)的发生率较低。GRADE 分析表明,纳入的 RCT 具有低质量证据。
与 30 min-SDI 相比,P-LDI 在 ORR 方面更优,且 3/4 级血小板减少症和白细胞减少症发生率较低,可为晚期 NSCLC 提供一种可行的治疗选择。然而,由于证据质量较低,需要高质量试验和大样本进一步验证这些结果。