Uriarte-Pinto Moisés, Escolano-Pueyo Ángel, Gimeno-Ballester Vicente, Pascual-Martínez Oihana, Abad-Sazatornil María Reyes, Agustín-Ferrández María José
Pharmacy Department, Miguel Servet University Hospital, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain.
Int J Clin Pharm. 2016 Apr;38(2):446-53. doi: 10.1007/s11096-016-0278-5. Epub 2016 Mar 7.
Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme.
We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response.
The study was carried out in a tertiary University Hospital of Spain.
This is a descriptive study of the clinical practice performed in our hospital.
Efficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment.
Thirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3-4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection.
The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.
基于曲妥珠单抗联合化疗的新辅助治疗是HER2阳性早期或局部晚期乳腺癌患者的标准治疗方案。尽管蒽环类药物和曲妥珠单抗均有潜在心脏毒性，但在这种情况下，曲妥珠单抗、蒽环类药物和紫杉类药物的联合使用仍很常见。然而，关于这种化疗方案的信息并不多。
我们想评估曲妥珠单抗、脂质体阿霉素和紫杉醇联合方案作为新辅助治疗方案的疗效和安全性。我们还试图确定病理完全缓解的预测因素。
该研究在西班牙一家三级大学医院进行。
这是一项对我院临床实践的描述性研究。
疗效通过病理完全缓解来衡量，病理完全缓解定义为新辅助治疗后乳腺和腋窝无浸润性癌细胞。
纳入30例患者，中位年龄48岁。17例（56.7%）激素受体（HR）阳性，14例（46.6%）临床分期为Ⅲa-b期，其中1例为炎性乳腺癌。12例患者（40%）达到病理完全缓解。HR阴性乳腺癌患者的病理完全缓解率高于HR阳性乳腺癌患者（分别为61.5%和23.5%；p值=0.035）。21例患者（70%）接受了保乳手术。该治疗总体耐受性良好，最常见的3-4级不良事件为中性粒细胞减少（20%）、乏力和肝酶改变（10%）以及发热性中性粒细胞减少（6.7%）。无患者发生心力衰竭，但1例（3.3%）左心室射血分数无症状性绝对降低10%。
研究的HER2阳性乳腺癌新辅助治疗方案似乎是一种有效的治疗选择。尽管该方案预期心脏毒性发生率较高，但研究结果表明该治疗方案似乎是安全的。曲妥珠单抗、非聚乙二醇化脂质体阿霉素和紫杉醇联合方案应考虑用于治疗HER2过表达乳腺癌。
