Abstract

This paper aims to evaluate the efficacy of capecitabine as extended adjuvant treatment after anthracycline and paclitaxel combined adjuvant chemotherapy for women with early triple-negative breast cancer (TNBC). The patients with early TNBC were randomly assigned to capecitabine sequential treatment for 4 cycles and without any sequential treatment in the control group after anthracycline and paclitaxel combined adjuvant chemotherapy. The primary end point was disease-free survival (DFS). The secondary end point was overall survival (OS). One hundred patients were enrolled in this study between June 2013 and February 2015. Median age was 49 years ranging from 25 to 66 years and treatment was well tolerance. The median follow-up time after random allocation was 58 months (range: 11–62 months). There was no significant difference in DFS and OS between the two groups (hazard ratio (HR) of DFS was 0.50; 95% CI, 0.24–1.05; P=0.066). Our study shows that although the addition of four cycles capecitabine after anthracycline and paclitaxel combining adjuvant chemotherapy does not improve DFS and OS, but the trend of DFS is improved. The possible reason is that the four-cycle treatment of capecitabine is not enough, and another possible reason is that the number of cases is not enough.

Highlights

  • Triple-negative breast cancer (TNBC) is a heterogeneous breast cancer subtype that is a complex and aggressive breast cancer with a poor prognosis

  • Many trials showed that it could benefit from adjuvant anthracyclines and/or paclitaxels [1, 2], even with this relatively effective chemotherapy, the 10-year recurrence rate of early TNBC is still close to 20–40% [3]. ere were other trials which suggested that the addition of other new agents including capecitabine, platinum-based agents, and ixabepilone could improve the prognosis

  • E study found that there was no significant difference in disease-free survival (DFS) (HR 0.81; 95% confidence intervals (CIs), 0.57–1.15) between the two groups, while there was a significant increase in overall survival (OS) (HR 0.62; 95% CI, 0.41–0.94) in favor of AC followed by cycles of TX (AC-TX) for TNBC subgroup

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Summary

Introduction

Triple-negative breast cancer (TNBC) is a heterogeneous breast cancer subtype that is a complex and aggressive breast cancer with a poor prognosis. Many trials showed that it could benefit from adjuvant anthracyclines and/or paclitaxels [1, 2], even with this relatively effective chemotherapy, the 10-year recurrence rate of early TNBC is still close to 20–40% [3]. Several prospective clinical trials have suggested that capecitabine improves the rate of progression-free survival and prognosis in the rescue treatment of metastatic breast cancer who have previously received anthracycline and paclitaxel [5, 6]. Ey showed that addition of capecitabine to TNBC could improve prognosis, either combination therapy or sequential therapy after neoadjuvant [3]. There is no study about sequential capecitabine after anthracycline and paclitaxel combined adjuvant therapy. Erefore, we decided to carry out a trial that received capecitabine sequential treatment for 4 cycles after anthracycline and paclitaxel combined adjuvant therapy in the early stage TNBC. Exclusion Criteria. (a) Advanced breast cancer. (b) With neoadjuvant therapy including chemotherapy, radiotherapy, and endocrine therapy. (c) Bilateral breast cancer, inflammatory breast cancer, or carcinoma in situ

Follow-Up
Statistical Analysis
Findings
The Result Discussion

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