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Meta-Analysis
. 2014 Aug 5;9(8):e104346.
doi: 10.1371/journal.pone.0104346. eCollection 2014.

Efficacy and safety of gemcitabine-fluorouracil combination therapy in the management of advanced pancreatic cancer: a meta-analysis of randomized controlled trials

Qin Li  1 , Han Yan  1 , Wenting Liu  2 , Hongchao Zhen  2 , Yifan Yang  2 , Bangwei Cao  2
Affiliations
Meta-Analysis

Efficacy and safety of gemcitabine-fluorouracil combination therapy in the management of advanced pancreatic cancer: a meta-analysis of randomized controlled trials

Qin Li et al. PLoS One. .

Abstract

Background: Gemcitabine (GEM) is the standard first-line chemotherapy that provides limited clinical benefits for patients with locally advanced/metastatic pancreatic adenocarcinoma (LA/MPC). However, the fluorouracil derivatives (CAP and S-1) show promising efficacy in these patients. This study compared the efficacy and safety of GEM with GEM plus fluorouracil drugs in the treatment of LA/MPC.

Methods: Pubmed, EMBASE and Cochrane Library databases were searched for relevant randomized controlled trials published on or before January 2014. The Cochrane Collaboration's tool was used to assess the risk of bias in randomized trials. The primary end point was overall survival (OS); the secondary end points were one-year survival rate, objective response rate (ORR) and toxicity rates (TRs).

Results: A total of 8 randomized controlled trials involving 2,126 patients were included in the systematic evaluation. The results showed that OS was significantly improved (HR 0.83, P<0.01; HR 0.87, P = 0.03; HR 0.80, P = 0.01; respectively) and ORR was significantly increased (OR 0.51, P<0.01; OR 0.66, P = 0.03; OR 0.35, P<0.01; respectively) in the GEM+5-FU/CAP/S-1, GEM+CAP and GEM+S-1 groups compared to the GEM alone group. In addition, the one-year survival rate was significantly increased (OR 0.78 P = 0.01; OR 0.47, P = 0.04; respectively) in the GEM+5-FU/CAP/S-1 and GEM+S-1 groups compared to the GEM alone group. The frequency of grade 3/4 TRs were higher in GEM+5-FU/CAP/S-1 group, the significant increase of grade 3/4 neutropenia, thrombocytopenia and diarrhea were observed.

Conclusions: GEM combined with fluorouracil drugs significantly improved OS and increased one-year survival rate and ORR compared to GEM alone in LA/MPC patients. GEM combined with fluorouracil drugs may be considered as an acceptable alternative treatment for LA/MPC patients.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. PRISMA flow diagram showing the exclusion and inclusion of trials in the meta-analysis.
Figure 2
Figure 2. The risk of bias for the included studies.
Figure 3
Figure 3. Comparison of overall survival between GEM combination therapy and GEM alone therapy.
Figure 4
Figure 4. Comparison of one-year survival rate between GEM combination therapy and GEM alone therapy.
Figure 5
Figure 5. Comparison of objective response rate between GEM combination therapy and GEM alone therapy.
Figure 6
Figure 6. Efficacy sub-analysis of the phase III trials.
Figure 7
Figure 7. Comparison of Grade 3–4 toxicity rates between GEM combination therapy and GEM alone therapy.
See this image and copyright information in PMC

References

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