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卡培他滨在蒽环类药物免疗方案治疗乳腺癌患者中的作用和疗效:系统评价和荟萃分析。

Role and efficacy of capecitabine in the anthracycline-free regimen in breast cancer patients: a systematic review and meta-analysis.

机构信息

Department of Breast and Thyroid Surgery, The Second Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.

Clinical Research Center for Breast and Thyroid Disease Prevention and Control in Hunan Province, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.

出版信息

J Cancer Res Clin Oncol. 2023 Dec;149(19):17671-17682. doi: 10.1007/s00432-023-05459-7. Epub 2023 Oct 27.

Abstract

PURPOSE

Capecitabine has extensive utilization in the treatment of diverse solid tumors, and its efficacy has been substantiated. Its oral administration and minimal toxicity in clinical practice render it advantageous. Nevertheless, uncertainty remains regarding whether capecitabine can substitute anthracycline drugs in chemotherapy regimens to achieve a lower risk of anthracycline-induced degradation. Consequently, we conducted a meta-analysis of randomized controlled trials (RCTs) to assess the potential of capecitabine as a replacement for anthracycline drugs in chemotherapy regimens for breast cancer.

METHODS

We systematically searched PubMed, Embase, Web of Science, and the Cochrane Controlled Trials Register (CENTRAL) to retrieve eligible studies published before July 18, 2023. Two independent reviewers extracted relevant data from the included studies using a pre-established data extraction form. The primary endpoints of interest encompassed overall survival (OS) and progression-free survival (PFS) for postoperative adjuvant therapy, as well as pathological complete response (PCR) following neoadjuvant therapy. Adverse events were considered as secondary outcomes. The statistical analysis was performed using Revman 5.4.1.

RESULTS

A total of six studies involving 2348 breast cancer patients were deemed eligible according to the selection criteria. The pooled meta-analysis revealed that there were no statistically significant differences observed in the primary outcomes of overall survival (OS) (HR 1.06, 95% CI 0.88-1.28) and progression-free survival (PFS) (HR 1.10, 95% CI 0.90-1.34) across the four postoperative adjuvant chemotherapy trials, as well as in the two neoadjuvant chemotherapy trials with respect to the primary outcome of pathological complete response (PCR) (OR 1.65, 95% CI 0.93-2.95) when comparing regimens containing anthracycline drugs to those without. In terms of adverse events, the probability of experiencing diarrhea (OR 3.94, P = 0.004) and hand-foot syndrome (OR 10.89, P = 0.004) was significantly higher in the capecitabine group, attributable to the drug characteristics. Conversely, the likelihood of developing neutropenia (OR 0.50, P = 0.03) was higher in the anthracycline group.

CONCLUSIONS

According to the current evidence, there was no statistically significant difference in the primary outcomes when capecitabine was substituted for anthracycline drugs. Thus, capecitabine can be regarded as a feasible alternative in the subset of patients who necessitate the exclusion of anthracyclines.

摘要

目的

卡培他滨在治疗多种实体肿瘤方面有广泛的应用,其疗效已得到证实。其在临床实践中的口服给药和低毒性使其具有优势。然而,卡培他滨是否可以替代化疗方案中的蒽环类药物,以降低蒽环类药物引起的降解风险,仍存在不确定性。因此,我们进行了一项荟萃分析,以评估卡培他滨作为乳腺癌化疗方案中蒽环类药物替代物的潜力。

方法

我们系统地检索了 PubMed、Embase、Web of Science 和 Cochrane 对照试验注册中心(CENTRAL),以获取截至 2023 年 7 月 18 日发表的合格研究。两位独立的评审员使用预先制定的数据提取表从纳入的研究中提取相关数据。主要研究终点包括术后辅助治疗的总生存期(OS)和无进展生存期(PFS),以及新辅助治疗后的病理完全缓解(PCR)。不良事件被视为次要结局。统计分析使用 Revman 5.4.1 进行。

结果

根据选择标准,共有六项研究涉及 2348 例乳腺癌患者被认为符合条件。荟萃分析显示,四项术后辅助化疗试验中,总生存期(OS)(HR 1.06,95%CI 0.88-1.28)和无进展生存期(PFS)(HR 1.10,95%CI 0.90-1.34)的主要结局以及两项新辅助化疗试验中包含蒽环类药物与不含蒽环类药物的方案相比,主要结局病理完全缓解(PCR)(OR 1.65,95%CI 0.93-2.95)均无统计学差异。在不良事件方面,卡培他滨组腹泻(OR 3.94,P=0.004)和手足综合征(OR 10.89,P=0.004)的发生概率明显更高,这归因于药物特性。相反,蒽环类药物组中性粒细胞减少(OR 0.50,P=0.03)的发生概率更高。

结论

根据目前的证据,当卡培他滨替代蒽环类药物时,主要结局没有统计学差异。因此,对于需要排除蒽环类药物的患者亚组,卡培他滨可以作为一种可行的替代药物。

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