Hu Yiyi, Chen Peizhen, Xiang Feng
Department of Pharmacy, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou 325027, Zhejiang, China.
J Oncol. 2023 Feb 8;2023:8740221. doi: 10.1155/2023/8740221. eCollection 2023.
This study aims to evaluate the efficacy of bevacizumab combined with capecitabine in treating HER2-negative metastatic breast cancer through meta-analysis.
We searched literature from databases, including PubMed, Web of Science, Wiley Online Library, Ovid, CNKI, and Wanfang databases, for randomized controlled trials (RCTs) of bevacizumab combined with capecitabine (experimental group) and other treatments (control group) for HER2-negative metastatic breast cancer. Retrieved articles were published from the establishment of the database to August 9, 2022. The main outcome indicators were disease progression rate (RDP), disease progression-free survival (PFS), 1-year survival rate (OSR), the occurrence of serious adverse events (SAEs), and objective remission rate (ORR). The risk of bias was assessed according to the Cochrane systematic evaluation tool. Then, the meta-analysis was carried out using Stata16.0 software, and subgroup analysis was carried out based on various intervention methods in the control group.
8 RCTs were finally included in this study, including 2470 patients with HER2-negative metastatic breast cancer. The results of meta-analysis showed that bevacizumab combined with capecitabine had no significant advantage over the control group in terms of RDP, but the results of subgroup analysis were consistent and significant (subgroup 1 (bevacizumab or chemotherapy): DR = -0.03, 95% CI (-0.14, 0.09), = 0.01; subgroup 2 (bevacizumab plus paclitaxel therapy): DR = -0.03, 95% CI (-0.14, 0.09), = 0.03). Furthermore, there was no statistical difference in terms of PFS of the experimental group (MD = 9.24, 95% CI (7.88, 32.67), = 0.05). However, the subgroup analysis showed that the combination of bevacizumab and capecitabine demonstrated a more significant significance than bevacizumab or chemotherapy alone (subgroup 1: MD = 10.11, 95% CI (7.88, 12.34), = 0.00). Compared with the control group, the experimental group had significant differences in OSR (DR = 0.07, 95% CI (-0.01, 0.15), = 0.00) and ORR (DR = 0.07, 95% CI (-0.01, 0.15), = 0.00). In terms of safety, the incidence of serious adverse events in the experimental group did not show a statistically significant difference (MD = 0.01, 95% CI (-0.21, 0.19), = 0.82). When subgroup analyses were performed, the bevacizumab plus capecitabine regimen was associated with an increased incidence of serious adverse events compared with the drug alone (subgroup 1: MD = 0.02, 95% CI (-0.16, 0.20), = 0.00) but a reduction in serious adverse events compared with the bevacizumab plus paclitaxel regimen (subgroup 2: DR = -0.01, 95% CI (-0.21, 0.19), = 0.00).
The combination therapy of bevacizumab and capecitabine can significantly improve the RDP and OSR of patients compared with the control group. The PFS and ORR of the experimental group are significantly higher than those of bevacizumab or chemotherapy alone. Still, no statistical difference was observed for these outcome indicators between two combined treatments of bevacizumab with capecitabine or paclitaxel. Although this combined treatment scheme may increase the incidence of serious adverse events compared with that of bevacizumab or chemotherapy alone, the incidence of adverse events was decreased compared with bevacizumab combined with paclitaxel. Therefore, the chemotherapy regimen for HER2-negative metastatic breast cancer in clinical practice can be selected according to the actual situation of the patients.
本研究旨在通过荟萃分析评估贝伐单抗联合卡培他滨治疗HER2阴性转移性乳腺癌的疗效。
我们检索了包括PubMed、Web of Science、Wiley Online Library、Ovid、中国知网（CNKI）和万方数据库在内的数据库中的文献，以查找贝伐单抗联合卡培他滨（实验组）与其他治疗方法（对照组）治疗HER2阴性转移性乳腺癌的随机对照试验（RCT）。检索的文章发表时间为数据库建立至2022年8月9日。主要结局指标为疾病进展率（RDP）、无疾病进展生存期（PFS）、1年生存率（OSR）、严重不良事件（SAEs）的发生率以及客观缓解率（ORR）。根据Cochrane系统评价工具评估偏倚风险。然后，使用Stata16.0软件进行荟萃分析，并根据对照组中的各种干预方法进行亚组分析。
本研究最终纳入8项RCT，包括2470例HER2阴性转移性乳腺癌患者。荟萃分析结果显示，贝伐单抗联合卡培他滨在RDP方面与对照组相比无显著优势，但亚组分析结果一致且具有显著性（亚组1（贝伐单抗或化疗）：DR = -0.03，95%CI（-0.14，0.09），P = 0.01；亚组2（贝伐单抗加紫杉醇治疗）：DR = -0.03，95%CI（-0.14，0.09），P = 0.03）。此外，实验组的PFS无统计学差异（MD = 9.24，95%CI（7.88，32.67），P = 0.05）。然而，亚组分析表明，贝伐单抗与卡培他滨联合使用比单独使用贝伐单抗或化疗具有更显著的意义（亚组1：MD = 10.11，95%CI（7.88，12.34），P = 0.00）。与对照组相比，实验组在OSR（DR = 0.07，95%CI（-0.01，0.15），P = 0.00）和ORR（DR = 0.07，95%CI（-0.01，0.15），P = 0.00）方面有显著差异。在安全性方面，实验组严重不良事件的发生率未显示出统计学显著差异（MD = 0.01，95%CI（-0.21，0.19），P = 0.82）。进行亚组分析时，贝伐单抗加卡培他滨方案与单独使用药物相比，严重不良事件的发生率增加（亚组1：MD = 0.02，95%CI（-0.16，0.20），P = 0.00），但与贝伐单抗加紫杉醇方案相比，严重不良事件减少（亚组2：DR = -0.01，95%CI（-0.21，0.19），P = 0.00）。
与对照组相比，贝伐单抗与卡培他滨联合治疗可显著提高患者的RDP和OSR。实验组的PFS和ORR显著高于单独使用贝伐单抗或化疗。然而，贝伐单抗与卡培他滨联合治疗或与紫杉醇联合治疗在这些结局指标上未观察到统计学差异。虽然这种联合治疗方案与单独使用贝伐单抗或化疗相比可能会增加严重不良事件的发生率，但与贝伐单抗联合紫杉醇相比，不良事件的发生率有所降低。因此，临床实践中HER2阴性转移性乳腺癌的化疗方案可根据患者的实际情况选择。
