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低危 HER2 阳性乳腺癌患者接受白蛋白结合型紫杉醇和曲妥珠单抗新辅助降阶梯治疗的研究

De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer.

机构信息

Department of Breast Surgery, National Hospital Organization, Osakaminami Medical Center, 2-1 Kidohigashi-cho, Kawachinagano-shi, Osaka, 586-8521, Japan.

Department of Breast Surgery, Osaka Rosai Hospital, 1179-3 Kita-Ku Nagasone-cho, Sakai-shi, Osaka, 591-8025, Japan.

出版信息

Cancer Chemother Pharmacol. 2019 Jun;83(6):1099-1104. doi: 10.1007/s00280-019-03836-z. Epub 2019 Apr 8.

Abstract

PURPOSE

Neoadjuvant trastuzumab combined with anthracycline and taxane is now considered a standard regimen for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. A less toxic, non-anthracycline regimen has been considered as a treatment option for patients with node-negative small tumors. Estrogen receptor-negative and HER2-positive (pure HER2) tumors are more likely to achieve a pathological complete response (pCR). This study evaluates the activity and safety of neoadjuvant nanoparticle albumin-bound paclitaxel (nab-PTX) plus trastuzumab for pure HER2 breast cancer in patients with low risk of relapse.

METHODS

We treated patients with tumors measuring ≤ 3 cm, node-negative, pure HER2 breast cancer using neoadjuvant nab-PTX 260 mg/m2 with trastuzumab every 3 weeks for four cycles. The primary endpoint was the pCR rate. The secondary endpoints included the clinical response rate, disease-free survival, pathologic response rate (defined as pCR or minimal residual invasive disease only in the breast), breast-conserving surgery conversion rate, safety, and disease-free survival. Depending on the pathological findings of surgical specimens, the administration of adjuvant anthracycline could be omitted.

RESULTS

Eighteen patients were enrolled. No patient required dose delays or reductions; none showed disease progression, and all patients underwent surgery as scheduled. Of the 18 patients, 66.7% achieved pCR, and the adjuvant anthracycline regimen was omitted for all patients. The incidence of severe adverse events was quite low.

CONCLUSION

This less toxic, anthracycline-free regimen appears to be a significantly effective neoadjuvant therapy for patients with pure HER2 breast cancer at low relapse risk.

摘要

目的

曲妥珠单抗联合蒽环类和紫杉类药物新辅助治疗现已被认为是人表皮生长因子受体 2(HER2)阳性乳腺癌的标准治疗方案。对于淋巴结阴性的小肿瘤患者,一种毒性较低的非蒽环类药物方案已被视为一种治疗选择。雌激素受体阴性和 HER2 阳性(纯 HER2)肿瘤更有可能实现病理完全缓解(pCR)。本研究评估了新辅助纳米白蛋白结合紫杉醇(nab-PTX)联合曲妥珠单抗治疗低复发风险的纯 HER2 乳腺癌患者的疗效和安全性。

方法

我们对肿瘤直径≤3cm、淋巴结阴性、纯 HER2 乳腺癌的患者采用新辅助 nab-PTX 260mg/m2联合曲妥珠单抗每 3 周给药 4 个周期。主要终点为 pCR 率。次要终点包括临床缓解率、无病生存期、病理缓解率(定义为 pCR 或仅在乳房中存在微小残留浸润性疾病)、保乳手术转化率、安全性和无病生存期。根据手术标本的病理发现,可以省略辅助蒽环类药物的治疗。

结果

共纳入 18 例患者。无患者需要延迟或减少剂量;无患者出现疾病进展,所有患者均按计划接受了手术。18 例患者中,66.7%达到了 pCR,所有患者均省略了辅助蒽环类药物的治疗。严重不良事件的发生率相当低。

结论

对于低复发风险的纯 HER2 乳腺癌患者,这种毒性较低的、不含蒽环类药物的方案似乎是一种非常有效的新辅助治疗方法。

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