剂量密集型蒽环序贯紫杉醇脂质体与蒽环序贯多西紫杉醇在局部晚期HER-2阴性乳腺癌新辅助化疗中的疗效及安全性比较

摘   要 背景与目的：剂量密集型的新辅助化疗在局部晚期乳腺癌中使用越来越广泛。但在剂量密集型的新辅助化疗方案中，使用紫杉醇脂质体的研究较少。本研究探讨剂量密集型蒽环序贯紫杉醇脂质体对比蒽环序贯多西紫杉醇在局部晚期HER-2阴性乳腺癌新辅助化疗中的安全性和疗效。方法：回顾性分析2017年1月—2018年12月可手术的局部晚期HER-2阴性的女性乳腺癌患者资料。该研究人群均行8周期新辅助化疗，其中196例采用蒽环序贯多西紫杉醇方案（多西紫杉醇组），48例采用剂量密集型蒽环序贯紫杉醇脂质体方案（紫杉醇脂质体组）。采用倾向性评分匹配（PSM）方法，按照1:1匹配两组基线特征差异后，比较两组患者病理完全缓解（pCR）与临床疗效情况以及不良事件发生率。结果：通过1:1 PSM匹配后，两组各48例患者。两组间pCR率无统计学意义（22.9% vs. 18.8%，P>0.05）；多西紫杉醇组客观缓解率（ORR）93.7%、疾病控制率（DCR）100.0%，紫杉醇脂质体组ORR与DCR均为100.0%，组间差异无统计学意义（P>0.05）。多西紫杉醇组III~IV度白细胞及中性粒细胞减少症的发生率以及III~IV度恶心、呕吐、乏力和口腔黏膜炎发生率均高于紫杉醇脂质体化疗组（均P<0.05），两组其他毒副反应的发生率比较，均无统计学意义（均P>0.05）。结论：在局部晚期HER-2阴性乳腺癌新辅助化疗中，蒽环序贯多西紫杉醇与剂量密集型蒽环序贯紫杉醇脂质体的疗效相当。紫杉醇脂质体化疗组毒副反应明显优于多西紫杉醇化疗组。紫杉醇脂质体可作为HER-2阴性乳腺癌新辅助化疗方案中紫杉醇类药物的优选。

Comparison of efficacy and safety of dose-dense anthracycline followed by paclitaxel liposome and anthracycline followed by docetaxel in neoadjuvant chemotherapy for locally advanced HER-2 negative breast cancer

Background and Aims: Dose-dense neoadjuvant chemotherapy is increasingly used in locally advanced breast cancer. However, there are few studies of using paclitaxel liposome in dose-dense neoadjuvant chemotherapy. Therefore, this study was conducted to compare the safety and efficacy of dose-dense anthracycline followed by paclitaxel liposome regimen and anthracycline followed by docetaxel regimen for neoadjuvant chemotherapy in patients with locally advanced HER-2 negative breast cancer. Methods: The clinical data of patients with resectable locally advanced HER-2 negative breast cancer treated from January 2017 to December 2018 were retrospectively collected. All patients received 8 cycles of neoadjuvant chemotherapy. There are 196 cases received anthracycline followed by docetaxel regimen (docetaxel group), and 48 cases received dose-dense anthracycline followed by paclitaxel liposome regimen (paclitaxel liposome group). After the baseline characteristics between two groups were adjusted using 1:1 propensity score matching (PSM) approach, the pathological completed response (pCR) and clinical efficacy as well as the incidence of adverse were compared between the two groups of patients.Results: There were 48 patients in each group after a 1:1 PSM analysis. There was no significant difference in pCR rates between the two groups (22.9% vs. 18.8%, P>0.05); the objective response rate (ORR) and disease control rate (DCR) were 93.7% and 100.0% in docetaxel group, and both ORR and DCR were 100.0% in paclitaxel liposome group, which showed no statistical differences between the two groups (P>0.05). The incidence rates of grade III-IV leucopenia and neutropenia, as well as the incidence rates of nausea, vomiting, fatigue and oral mucositis in docetaxel group were significantly higher than those in paclitaxel liposome group (all P<0.05), but no significant differences were noted in incidence rates of other adverse reactions between the two groups (all P>0.05).Conclusion: Anthracycline followed by docetaxel regimen and dose-dense anthracycline followed by paclitaxel liposome regimen have similar efficacy in neoadjuvant chemotherapy for locally advanced HER-2 negative breast cancer. The safety of dose-dense anthrancycline followed by paclitaxel liposome regimen is obviously superior to that of anthrancycline followed by docetaxel regimen. Paclitaxel liposome can be used as a first choice of paclitaxel options in neoadjuvant chemotherapy regimen for HER-2 negative breast cancer.