ObjectiveTo 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).MethodsElectronic 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.ResultsSix 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.ConclusionP-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.
Background The present standard dose of gemcitabine (Gem), a pyrimidine antimetabolite, is 1,000–1,250 mg/m 2 , and the infusion time is 30 min. However, pharmacological studies have demonstrated that Gem with prolonged infusion could attain a better accumulation rate of Gem triphosphate (active metabolites of Gem), indicating that Gem with prolonged infusion is superior to 30-min infusion. Thus, this systematic review aims to provide some references for Gem administered as a prolonged infusion. Methods We searched electronic databases, including PubMed, EMBASE, Cochrane Library, and CNKI, for trials. Keywords were “Gem,” “prolonged infusion,” and “low-dose.” In addition, we used the Cochrane Handbook V5.1.0 and methodological index for non-randomized studies to evaluate the quality of randomized controlled trials (RCTs) and non-RCTs, respectively. Furthermore, Cochrane Collaboration guidelines and the PRISMA statement were adopted. Results We systematically reviewed 19 studies (5 RCTs and 14 non-RCTs). All studies assessed the efficacy and safety of Gem administered as a prolonged low-dose infusion (P-LDI) and reported that Gem administered as P-LDI was effective and well tolerated. Conclusion Gem administered as P-LDI is effective, safe, and economical, especially suited for patients with poor performance status or without good economic condition.
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