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).
CONCLUSIONS: 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.
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).
CONCLUSIONS: 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：纳米颗粒-白蛋白结合型紫杉醇（Nab-P）对乳腺癌患者常规紫杉烷类的长期益处仍存在争议。我们对研究进行了系统评价，以确定临床实践中选择的最佳紫杉烷类药物。
方法：我们招募了患有乳腺癌的成年人（年龄≥18岁），将Nab-P（任何剂量）与常规紫杉醇或多西他赛进行比较，提供了有关生存数据的信息，响应率，或不良事件，是随机对照试验，病例对照研究，或队列研究，并以英文出版(包括在线出版的，在印刷出版物之前)。使用Cochrane协作工具和纽卡斯尔-渥太华量表进行偏倚风险评估。建议评估的分级，发展,并采用评价方法对证据质量进行评价。结果包括总体反应率，病理完全缓解率，无进展生存期,总生存率,过敏反应,白细胞减少症,中性粒细胞减少症,和感觉神经病变。
结果：共20项合格临床研究，包括11,046例患者纳入分析。基于对无进展生存期（PFS）的漏斗图的目视检查，未观察到明显的发表偏倚，总生存率（OS）。与常规紫杉烷类组(n=2,743)相比，Nab-P组（n=1,680）的ORR（RR=1.21，95％CI：1.07-1.37；P=0.003）和pCR（RR=1.33，95％CI：1.17-1.51；P<0.001）明显更高。Nab-P组的疾病进展和死亡风险也低于常规紫杉烷组(HR=0.89,P=0.269)。此外,与常规紫杉烷组相比,Nab-P组治疗相关的过敏反应较少(RR=0.74,95%CI:0.59~0.93;P=0.009),且≥4级中性粒细胞减少(RR=0.39,95%CI:0.20~0.77;P=0.007)较少.Nab-P组任何级别的中性粒细胞减少症和感觉神经病变的发生率均明显高于常规紫杉烷组（分别为P=0.009和P<0.001）。
结论：Nab-P在各阶段乳腺癌患者中的疗效和耐受性均明显优于常规紫杉烷类药物。此外，未来的研究应探讨降低Nab-P诱发的感觉神经病变发生率的预防策略.
方法：我们招募了患有乳腺癌的成年人（年龄≥18岁），将Nab-P（任何剂量）与常规紫杉醇或多西他赛进行比较，提供了有关生存数据的信息，响应率，或不良事件，是随机对照试验，病例对照研究，或队列研究，并以英文出版(包括在线出版的，在印刷出版物之前)。使用Cochrane协作工具和纽卡斯尔-渥太华量表进行偏倚风险评估。建议评估的分级，发展,并采用评价方法对证据质量进行评价。结果包括总体反应率，病理完全缓解率，无进展生存期,总生存率,过敏反应,白细胞减少症,中性粒细胞减少症,和感觉神经病变。
结果：共20项合格临床研究，包括11,046例患者纳入分析。基于对无进展生存期（PFS）的漏斗图的目视检查，未观察到明显的发表偏倚，总生存率（OS）。与常规紫杉烷类组(n=2,743)相比，Nab-P组（n=1,680）的ORR（RR=1.21，95％CI：1.07-1.37；P=0.003）和pCR（RR=1.33，95％CI：1.17-1.51；P<0.001）明显更高。Nab-P组的疾病进展和死亡风险也低于常规紫杉烷组(HR=0.89,P=0.269)。此外,与常规紫杉烷组相比,Nab-P组治疗相关的过敏反应较少(RR=0.74,95%CI:0.59~0.93;P=0.009),且≥4级中性粒细胞减少(RR=0.39,95%CI:0.20~0.77;P=0.007)较少.Nab-P组任何级别的中性粒细胞减少症和感觉神经病变的发生率均明显高于常规紫杉烷组（分别为P=0.009和P<0.001）。
结论：Nab-P在各阶段乳腺癌患者中的疗效和耐受性均明显优于常规紫杉烷类药物。此外，未来的研究应探讨降低Nab-P诱发的感觉神经病变发生率的预防策略.
