A systematic review of gemcitabine and taxanes combination therapy randomized trials for metastatic breast cancer.

Qian Hu,Xiao Lin,Jun-Yan Wu,Xiao-Xiao Dinglin,Long Luo,He-Rui Yao,Wei Zhang,Jun-Xia Jiang,Xing Yang

doi:10.1186/2193-1801-3-293

Qian Hu, Xiao Lin + Show 7 more

Open Access

https://doi.org/10.1186/2193-1801-3-293

Copy DOI

Abstract

PurposeGemcitabine/taxanes-based combination shows anti-tumor activity for the treatment of metastatic breast cancer, but there is a debate regarding the advantages of gemcitabine and taxanes regimens as a first-line or second-line treatment for metastatic breast cancer. Here we conducted a systematic review and meta-analysis to compare the efficacy and toxicity for patients receiving chemotherapy with or without GT-based regimens.MethodsThe randomized controlled trials were performed by searching Pubmed, MEDLINE, EMBASE, and conference proceedings. We identified eight randomized controlled trials and then extracted and combined the data using to calculate hazard ratios (HR). The primary outcomes were progression-free survival (PFS) and time to progression (TTP). The secondary outcomes were overall survival (OS) and acute toxicity. A meta-analysis was performed using Review Manager Version 4.2.ResultsEight eligible trails were identified. These studies involved 2234 patients with metastatic breast cancer, (1122 patients received GT-based combination regimen and 1112 patients received a regimen without the combination). A fixed-effects model meta-analysis showed that ORR and TTP are superior for GT-treated patients ORR (OR = 1.28, 95% CI 1.07-1.53), TTP (HR = 0.80; 95% CI 0.71-0.89). And GT-based combination significantly improved OS in the first-line subgroup (HR = 0.84; 95% CI 0.71-0.99). However, there were significant differences regarding acute hematological toxicity, particularly thrombocytopenia.ConclusionGemcitabine/taxanes-treated patients with metastatic breast cancer showed a significant improvement in the ORR, TTP and OS (first-line background) compared to patients not treated with the combination regimen.

Highlights

Breast cancer is a major primary malignancy affecting the health of women, and the morbidity and mortality continue to increase in developed countries (Hortobagyi et al 2005; Albain et al 2005)
We submitted the details of our systematic review “Gemcitabine-based chemotherapy for MBC: a systematic review and meta-analysis of randomized controlled trials” to the PROSPERO register
After reading the full text, one article was excluded because gemcitabine was administered separately

Summary

Introduction

Breast cancer is a major primary malignancy affecting the health of women, and the morbidity and mortality continue to increase in developed countries (Hortobagyi et al 2005; Albain et al 2005). Several phase II clinical trials demonstrated that the overall response rate of single agent gemcitabine ranged from 15% to 38% (Blackstein et al 2002; Hensley et al 2002; Seidman 2001). Taxanes is good combination agent with gemcitabine, including paclitaxel and docetaxel.To define the combination regimen including gemcitabine in MBC, physicians have conducted phase III clinical trials to compare the efficacy and toxicity between regimens MBC (Albain et al 2008; Chan et al 2009; Joensuu et al 2010; Zielinski et al 2005; Levy & Fumoleau 2005; Brufsky et al 2011; Nielsen et al 2011; Papadimitriou et al 2009).The combination of gemcitabine/taxanes-based(GT-based) combination is an effective regimen that is well tolerated with good response rates (Gudena et al 2008).

Methods

Results

Conclusion