Evaluating The Survival Benifit Of An Capecitabine In Combination With Standard Regimens In Patients With Early Breast Cancer

Purpose Capecitabine in addition to anthracycline-taxane based regimens for patients with early breast cancer(EBC)has been reported in previous clinical trials,but the reported efficacy of this regimen remained inconsistent.In order to clarify the survival benefit of this regimen,a meta-analysis was performed.Methods The systematic literature search was conducted in Pub Med,the Cochrane library and Google scholar.Relevant papers that were published from January to August 2016 were included.The latest conference abstracts were searched in American Society of Clinical Oncology(www.asco.org).The hazard ratios(HRs)and their 95% confidence intervals(CI)were used to evaluate the efficacy and adverse events.The Jadad Quality Assessment.The Jadad Quality Assessment scale(7 pointsl)for cohort studies was used to assess the quality of the inclusive trials in our analysis,and including the follow items: methods of randomization,allocation concealment,blinding status and results(withdrawals and dropouts).The primary efficacy outcome of our meta-analysis was disease-free survival(DFS).And the secondary endpoints were overall survival(OS),relapse-free survival(RFS),pathologic complete response(p CR).Outcomes measures were based on the intention-to-treat(ITT)analysis.Efficacy and adverse events analysis was compared between the two groups used the pooled log hazard ratios(HRs),and their 95% confidence intervals(CI)were also provided.The subgroup analyses were performed by including the hormone receptor(HR)status,HER2 status,triple negative status,distant-DFS,and breast cancer specific survival.A random effects model was used for drawing forest plots which are designed to demonstrate data distribution of the included articles.The between-study heterogeneity was tested with I-squared statistic and p values.The probability of publication bias was assessed with the funnel plots and the Egger’s testResultsA total of seven trials(included ten articles)were identified from potential relevant studies base on the inclusion criteria.All the included studies were randomized prospective cohort studies which included 7,416 early breast cancer patients;3,725 received an anthracycline-taxane-capecitabine containing regimen and 3,691 received an anthracycline-taxane based regimen.The result indicated that capecitabine combine with an anthracycline-taxane based regimen would significantly improve DFS(HR=0.87,95%CI 0.77-0.97),OS(HR=0.78,95%CI 0.66-0.91)and RFS(HR=0.79,95%CI 0.64-0.93,I2=16.6%,P=0.302)compared with the controls.No significant increase in the p CR rate was found in the capecitabine group(HR=0.94,95%CI 0.81-1.07,I2=31.8%,P=0.222)compared with the control group.In subgroup analysis,we found that capecitabine improved the DFS in hormone receptor negative(HR=0.72,95%CI 0.53-0.92)and triple negative(HR=0.67,95%CI 0.49-0.86)EBC patients.However,adding capecitabine might also increase the occurrence of some side-effects,such as hand-foot syndrome,stomatitis and diarrhea.Conversely,the capecitabine group had significantly fewer cases of some side-effects,such as leucopenia,febrile neutropenia)and myosalgia.Conclusion Capecitabine combined with an anthracycline-taxane based regimen maybe effective and well-tolerated by patients with EBC,especially for triple negative breast cancer,and might be a good clinical choice.