Department of Thyroid and Breast Surgery, The People's Hospital of Ganzhou, Ganzhou Affiliated Hospital of Nanchang University, Ganzhou 341000, Jiangxi Province, China.
J Healthc Eng. 2022 Feb 28;2022:7430775. doi: 10.1155/2022/7430775. eCollection 2022.
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; =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.
本研究旨在评估卡培他滨作为蒽环类和紫杉醇联合辅助化疗后早期三阴性乳腺癌（TNBC）患者的扩展辅助治疗的疗效。早期 TNBC 患者被随机分配接受卡培他滨序贯治疗 4 个周期，对照组在蒽环类和紫杉醇联合辅助化疗后不进行任何序贯治疗。主要终点是无病生存期（DFS）。次要终点是总生存期（OS）。本研究于 2013 年 6 月至 2015 年 2 月期间纳入了 100 名患者。中位年龄为 49 岁，范围为 25-66 岁，治疗耐受性良好。随机分组后中位随访时间为 58 个月（范围：11-62 个月）。两组之间 DFS 和 OS 无显著差异（DFS 的 HR 为 0.50；95%CI，0.24-1.05；=0.066）。我们的研究表明，尽管在蒽环类和紫杉醇联合辅助化疗后加用 4 个周期卡培他滨并未改善 DFS 和 OS，但 DFS 的趋势有所改善。可能的原因是卡培他滨的 4 个周期治疗不够，另一个可能的原因是病例数不够。
