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白蛋白结合型紫杉醇纳米粒与传统紫杉类药物治疗乳腺癌女性患者的疗效和安全性的系统评价和荟萃分析。

Efficacy and safety of nanoparticle-albumin-bound paclitaxel compared with conventional taxanes in women with breast cancer: a systematic review and meta-analysis.

机构信息

Department of Breast Medical Oncology, Cancer Hospital of the University of Chinese Academy of Sciences/Zhejiang Cancer Hospital, Hangzhou, China.

School of Public Health, Zhejiang Chinese Medical University, Hangzhou, China.

出版信息

Ann Palliat Med. 2022 Jul;11(7):2382-2394. doi: 10.21037/apm-22-690.

DOI:10.21037/apm-22-690
PMID:35927773
Abstract

BACKGROUND

Long-term benefit of nanoparticle-albumin-bound paclitaxel (Nab-P) over conventional taxanes in breast cancer patients is still controversial. We conducted a systematic review of studies to identify the optimal taxanes for selection in clinical practice.

METHODS

We enrolled studies if they enrolled adults (age ≥18) with breast cancer, compared Nab-P (at any dose) to conventional paclitaxel or docetaxel, provided information on survival data, the response rate, or adverse events, were randomized controlled trials, case-control studies, or cohort studies, and were published in English (including those published online, ahead of the print publication). Cochrane Collaboration tool and Newcastle-Ottawa scale were used for bias-risk assessment. Grading of recommendations assessment, development, and evaluation approach were adopted for the quality of evidence evaluation. The outcomes included the overall response rate, pathological complete response rate, progression-free survival, overall survival, allergic reaction, leukopenia, neutropenia, and sensory neuropathy.

RESULTS

A total of 20 eligible clinical studies comprising 11,046 patients were included in the analysis. No significant publication bias was observed based on a visual inspection of the funnel plots for progressionfree survival (PFS), and overall survival (OS). Compared to the conventional taxanes group (n=2,743), the Nab-P group (n=1,680) had a significantly higher ORR (RR =1.21, 95% CI: 1.07-1.37; P=0.003) and pCR (RR =1.33, 95% CI: 1.17-1.51; P<0.001). The Nab-P group also had a lower risk of disease progression and death than the conventional taxanes group (HR =0.89, P=0.269). Additionally, the Nab-P group had fewer treatment-related allergic reactions (RR =0.74, 95% CI: 0.59-0.93; P=0.009) and less grade ≥4 neutropenia (RR =0.39, 95% CI: 0.20-0.77; P=0.007) than the conventional taxanes group. The incidence of any-grade of neutropenia and sensory neuropathy were significantly higher in the Nab-P group than the conventional taxanes group (P=0.009 and P<0.001, respectively).

DISCUSSION

The Nab-P in all stages of breast cancer patients had significantly better efficacy and tolerance than the conventional taxanes. Moreover, preventive strategies for reducing the incidence of Nab-P induced sensory neuropathy should be explored in future studies.

摘要

背景

纳米白蛋白结合紫杉醇(Nab-P)与传统紫杉烷类药物在乳腺癌患者中的长期获益仍存在争议。我们进行了一项系统评价,以确定在临床实践中选择最佳紫杉烷类药物的方法。

方法

如果研究纳入了成年(年龄≥18 岁)乳腺癌患者,将 Nab-P(任何剂量)与传统紫杉醇或多西他赛进行比较,提供生存数据、反应率或不良反应的信息,且为随机对照试验、病例对照研究或队列研究,并以英文发表(包括在线发表的研究),则纳入本研究。采用 Cochrane 协作工具和纽卡斯尔-渥太华量表评估偏倚风险。采用推荐评估、制定与评价分级方法评估证据质量。结局包括总缓解率、病理完全缓解率、无进展生存期、总生存期、过敏反应、白细胞减少、中性粒细胞减少和感觉神经病变。

结果

共纳入 20 项符合条件的临床研究,包括 11046 例患者。无进展生存期(PFS)和总生存期(OS)的漏斗图目测未发现明显的发表偏倚。与传统紫杉烷组(n=2743)相比,Nab-P 组(n=1680)的总缓解率(RR=1.21,95%CI:1.07-1.37;P=0.003)和病理完全缓解率(RR=1.33,95%CI:1.17-1.51;P<0.001)更高。Nab-P 组的疾病进展和死亡风险也低于传统紫杉烷组(HR=0.89,P=0.269)。此外,Nab-P 组治疗相关过敏反应(RR=0.74,95%CI:0.59-0.93;P=0.009)和≥4 级中性粒细胞减少症(RR=0.39,95%CI:0.20-0.77;P=0.007)的发生率低于传统紫杉烷组。Nab-P 组的任何级别中性粒细胞减少症和感觉神经病变的发生率均显著高于传统紫杉烷组(P=0.009 和 P<0.001)。

讨论

Nab-P 在乳腺癌患者的所有阶段均具有明显更好的疗效和耐受性。此外,未来的研究应探索降低 Nab-P 诱导的感觉神经病变发生率的预防策略。

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