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白蛋白结合型紫杉醇与溶剂型紫杉类药物作为乳腺癌新辅助治疗的比较:系统评价和荟萃分析。

Comparison between nab-paclitaxel and solvent-based taxanes as neoadjuvant therapy in breast cancer: a systematic review and meta-analysis.

机构信息

Breast Center, Peking University People's Hospital, Beijing, China.

出版信息

BMC Cancer. 2021 Feb 4;21(1):118. doi: 10.1186/s12885-021-07831-7.

Abstract

BACKGROUND

To compare the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and solvent-based taxanes (sb-taxanes) as neoadjuvant therapy in the treatment of breast cancer.

METHODS

We systematically searched the PubMed, Embase, and Cochrane Central Register databases. Randomized controlled trials (RCTs) and cohort studies, published in English, about the comparison between nab-paclitaxel and sb-taxanes as neoadjuvant therapy in patients with breast cancer were searched up to September 2019.

RESULTS

The primary outcome was the proportion of patients with pathological complete response (pCR, defined as ypT0 ypN0 or ypT0/is ypN0). Other main outcomes included long-term survival and adverse events (AEs). Seven studies (five RCTs and two cohorts) and 2949 patients were included. Neoadjuvant nab-paclitaxel improved pCR compared with sb-taxanes (ypT0 ypN0: OR = 1.52, 95%CI: 1.27-1.83, P < 0.001; ypT0/is ypN0: OR = 1.40, 95%CI: 1.17-1.68, P < 0.001). The benefits of nab-paclitaxel on pCR were persistent in HER2-negative, hormone receptor (HR)-positive breast cancer (OR = 1.53, 95%CI: 1.07-2.19, P = 0.020), triple-negative breast cancer (weekly/every 2 weeks regimen; OR = 2.95, 95%CI: 1.54-5.67, P < 0.001), and tumors with Ki-67 > 20% (OR = 1.63, 95%CI: 1.26-2.12, P < 0.001). Patients treated with nab-paclitaxel had better event-free survival (EFS; HR = 0.69, 95%CI: 0.57-0.85, P < 0.001) than with sb-taxanes. There were no differences in most of grade > 3 AEs between nab-paclitaxel and sb-taxanes (all P > 0.05), besides of any grade hypersensitivity (OR = 0.29, 95%CI: 0.11-0.72, P = 0.008), any grade (OR = 2.10, 95%CI: 1.37-3.23, P = 0.001) and grade > 3 (OR = 4.01, 95%CI: 2.51-6.41, P < 0.001) neuropathy.

CONCLUSION

Nab-paclitaxel is effective for the treatment of non-metastatic breast cancer in the neoadjuvant setting. Nab-paclitaxel could improve pCR rate and EFS compared with sb-taxanes and with reasonable toxicities.

摘要

背景

比较纳米白蛋白结合紫杉醇(nab-紫杉醇)和基于溶剂的紫杉烷类药物(sb-紫杉烷类药物)作为新辅助治疗在乳腺癌治疗中的疗效和安全性。

方法

我们系统地检索了 PubMed、Embase 和 Cochrane 中央注册数据库。检索截至 2019 年 9 月,发表在英文期刊上的关于 nab-紫杉醇和 sb-紫杉烷类药物作为乳腺癌患者新辅助治疗的随机对照试验(RCT)和队列研究。

结果

主要结局是病理完全缓解(pCR,定义为ypT0 ypN0 或 ypT0/is ypN0)的患者比例。其他主要结局包括长期生存和不良事件(AE)。纳入了 7 项研究(5 项 RCT 和 2 项队列研究),共 2949 例患者。新辅助 nab-紫杉醇与 sb-紫杉烷类药物相比提高了 pCR(ypT0 ypN0:OR=1.52,95%CI:1.27-1.83,P<0.001;ypT0/is ypN0:OR=1.40,95%CI:1.17-1.68,P<0.001)。nab-紫杉醇在 HER2 阴性、激素受体(HR)阳性乳腺癌(OR=1.53,95%CI:1.07-2.19,P=0.020)、三阴性乳腺癌(每周/每 2 周方案;OR=2.95,95%CI:1.54-5.67,P<0.001)和 Ki-67>20%的肿瘤(OR=1.63,95%CI:1.26-2.12,P<0.001)中 pCR 的获益持续存在。与 sb-紫杉烷类药物相比,接受 nab-紫杉醇治疗的患者无事件生存(EFS;HR=0.69,95%CI:0.57-0.85,P<0.001)更好。nab-紫杉醇与 sb-紫杉烷类药物之间大多数>3 级 AE 的发生率没有差异(均 P>0.05),除了任何等级过敏反应(OR=0.29,95%CI:0.11-0.72,P=0.008)、任何等级(OR=2.10,95%CI:1.37-3.23,P=0.001)和>3 级(OR=4.01,95%CI:2.51-6.41,P<0.001)神经病变。

结论

Nab-紫杉醇在新辅助治疗非转移性乳腺癌方面是有效的。与 sb-紫杉烷类药物相比,nab-紫杉醇可提高 pCR 率和 EFS,同时具有合理的毒性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7438/7863369/7ec7c10811b3/12885_2021_7831_Fig1_HTML.jpg

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