PURPOSE Based on improvement in pathologic complete response (pCR) in the NeoSphere and TRYPHAENA studies, the FDA approved neoadjuvant pertuzumab for HER2+ localized breast cancer. These studies demonstrated high pCR rates with THP (docetaxel + HP), FEC (5-fluorouracil, epirubicin, and cyclophosphamide)-THP, and TCHP (docetaxel, carboplatin + HP). However, in the United States, doxorubicin/cyclophosphamide (AC) is favored over FEC despite no data comparing neoadjuvant AC-THP with AC-TH or TCHP. Here we report outcomes for patients with localized HER2+ breast cancer treated with pertuzumab-containing neoadjuvant regimens and AC-TH. METHODS We reviewed clinicopathological characteristics of patients with HER2+ breast cancer (Stage I-III) treated with either a neoadjuvant pertuzumab-containing regimen or dose-dense (dd) AC-TH, from 2011 to 2016 at a large academic medical institution and two affiliated community sites. pCR was defined as ypT0/is ypN0. Fisher's exact test and logistic regression analysis were used for statistical analysis. RESULTS In this study (N = 121), pCR was numerically higher with pertuzumab-based regimens, including ddAC-THP (60%), TCHP (63%), THP (55%), as compared with ddAC-TH (46%). THP resulted in significantly less cycle delays due to toxicity compared to the other regimens (p = 0.02). THP also resulted in the least dose reductions, lowest rate of hospitalization, and lowest rate of treatment discontinuation. CONCLUSIONS Pertuzumab-based regimens, including THP, resulted in higher pCR rates as compared to ddAC-TH, with the THP regimen associated with the best tolerability among patients with localized HER2+ breast cancer. Given the various neoadjuvant regimens, additional studies are needed to determine optimal treatment sequencing and escalation/de-escalation strategies to personalize neoadjuvant regimens for localized HER2+ breast cancer.

中文翻译：

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HER2阳性局限性乳腺癌的新辅助含帕妥珠单抗方案的有效性和耐受性。

目的基于在NeoSphere和TRYPHAENA研究中病理完全缓解（pCR）的改善，FDA批准了新的帕妥珠单抗用于HER2 +局部乳腺癌。这些研究表明，THP（多西他赛+ HP），FEC（5-氟尿嘧啶，表柔比星和环磷酰胺）-THP和TCHP（多西他赛，卡铂+ HP）具有较高的pCR率。然而，在美国，尽管尚无将新辅助剂AC-THP与AC-TH或TCHP进行比较的数据，但阿霉素/环磷酰胺（AC）比FEC更受青睐。在这里，我们报告了用含帕妥珠单抗的新辅助方案和AC-TH治疗的局限性HER2 +乳腺癌患者的结局。方法我们回顾了接受新的含帕妥珠单抗治疗或剂量密集（dd）AC-TH治疗的HER2 +乳腺癌（I-III期）患者的临床病理特征，从2011年到2016年在一家大型学术医疗机构和两个附属社区站点工作。将pCR定义为ypT0 /是ypN0。Fisher的精确检验和逻辑回归分析用于统计分析。结果在这项研究（N = 121）中，基于帕妥珠单抗的方案，包括ddAC-THP（60％），TCHP（63％），THP（55％）的pCR数值高于ddAC-TH（46％ ）。与其他方案相比，THP由于毒性导致的周期延迟显着减少（p = 0.02）。THP还导致剂量减少最少，住院率最低和治疗中断率最低。结论与ddAC-TH相比，基于Pertuzumab的治疗方案（包括THP）导致更高的pCR率，而THP治疗方案与局部HER2 +乳腺癌患者的最佳耐受性相关。