随着抗人表皮生长因子受体2（human epidermalgrowth factor receptor 2 ，HER2）抗肿瘤药物的不断出现及广泛应用，HER2 阳性乳腺癌患者的治疗以及预后得到了显著的改善。PEONY 研究结果的发布再次奠定了帕妥珠单抗+曲妥珠单抗的双靶治疗模式在新辅助治疗领域中的地位；结合TRYPHAENA 和TRAIN-2 两项研究，紫杉类+铂类应该是抗HER2 双靶治疗的首选化疗方案，疗程宜6 个周期。结合中国乳腺癌新辅助治疗专家共识和辅助APT 研究的最新随访结果，新辅助治疗适用人群为肿瘤直径超过3 cm 和/或淋巴结阳性的患者，新辅助治疗后如果没有获得pCR，T-DM1 应该是辅助治疗的首选模式，帕妥珠单抗+曲妥珠单抗的双靶辅助模式期待PEONY 研究的后续生存随访；对于没有淋巴结转移的小肿瘤（≤3 cm）低危患者可以考虑免除新辅助治疗，采取直接手术+术后给予曲妥珠单抗联合单药紫杉醇的辅助治疗模式。曲妥珠单抗+帕妥珠单抗联合紫杉类药物依然是晚期HER2 阳性患者的标准一线治疗；对于中国患者而言，吡咯替尼联合卡培他滨可以作为二线的优选；T-DM1 可以作为三线及后线选择；曲妥珠单抗、帕妥珠单抗、T-DM1 治疗失败的情况下，DS-8201 成为新的选择模式；伴有脑转移的HER2 阳性晚期乳腺癌患者则可以考虑图卡替尼与曲妥珠单抗和卡培他滨的联合治疗模式。

The efficacy and prognosis of human epidermal growth factor receptor 2 (HER2) positive breast cancer patients have been significantly improved with the development and wide application of anti-tumor drugs against HER2. The results of PEONY research once again established the status of the double-target treatment mode of pertuzumab+trastuzumab in the field of neoadjuvant therapy.Based on the two studies of TRYPHAENA and TRAIN-2, paclitaxel plus platinum should be the first choice chemotherapy scheme for anti HER2 double-target therapy, and the treatment course of 6 cycles is preferred. According to the consensus of neoadjuvant therapy experts in China and the latest follow-up results of adjuvant APT study, the neoadjuvant therapy is more suitable for patients with a tumor diameter of more than 3 cm and/or positive lymph nodes metastasis; T-DM1 should be the first choice of adjuvant therapy in patients, who didn’t obtain pCR after neoadjuvant treatment, and whether the double-target adjuvant mode of pertuzumab plus trastuzumab is suitable depends on follow-up of the PEONY study. Low-risk patients with small tumors (<3 cm) and without lymph node metastasis may consider omitting neoadjuvant therapy but adopt direct surgery followed by postoperative adjuvant therapy with trastuzumab plus paclitaxel. The regimen of trastuzumab+pertuzumab combined with taxanes is still the standard first line treatment of late stage HER2+ patients; for Chinese patients, pyrotinib combined with capecitabine can be used as the second line optimization,and T-DM1 can be used as the third line and posterior line selection; when trastuzumab, pertuzumab and T-DM1 fail the treatment,DS-8201 becomes a new selection mode. Combined treatment mode of tucatinib plus trastuzumab and capecitabine can be considered in late stage HER2+ patients with brain metastases.

国家自然科学基金资助项目（No. 81803914，81803004）