Xiu M, Lu Y, Wang X, Fan Y, Li Q, Li Q, Wang J Y, Luo Y, Cai R G, Chen S S, Yuan P, Ma F, Xu B H, Zhang P
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Department of Medical Oncology, the First People's Hospital of Nanning, Nanning 530016, China.
Zhonghua Zhong Liu Za Zhi. 2023 Aug 23;45(8):709-716. doi: 10.3760/cma.j.cn112152-20221006-00678.
To provide survival evidence of anthracycline-free neoadjuvant chemotherapy for patients with stages Ⅱ-Ⅲ human epidermal growth factor receptor-2 (HER-2) positive and hormone receptor (HR) negative breast cancer. The prospective cohort study was conducted at the Department of Medical Oncology of Cancer Hospital, Chinese Academy of Medical Sciences. Patients with HER-2 positive and HR negative breast cancer in stages Ⅱ-Ⅲ were enrolled to receive neoadjuvant therapy (NAT) of dose-dense paclitaxel (175 mg/m(2)) plus carboplatin (AUC=4.0) biweekly for 6 cycles in combination with trastuzumab (PCbH), and matched patients who received standard adjuvant therapy of physicians' choice were recruited for survival and safety comparison. From July 2013 to November 2019, 166 patients were included (neoadjuvant 51, adjuvant 115). Compared with those who received adjuvant therapy, patients receiving NAT were younger (<35 years: 19.6% vs 5.2%, =0.014), had larger tumors (T3: 62.7% vs 7.8%, <0.001) and more advanced diseases (stage ⅡA: 2.0% vs 41.7%, <0.001). Patients in the neoadjuvant group all received surgery, and 96 (83.5%) in the adjuvant group received anthracycline-and-taxane-containing regimens. A total of 98 patients (49 pairs) were matched, and the covariates between the two groups were acceptably balanced. Within a median follow-up of 46.5 (range, 14-87) months, the 4-year recurrence-free survival (RFS) rate among patients who received NAT was 73.3% (95% 59.0%-87.6%), versus 80.6% (95% 67.9%-93.3%) among those in the adjuvant group without statistical difference (=0.418). A similar result was observed for the 4-year overall survival (OS) [neoadjuvant versus adjuvant: 91.5% (95% 81.7%-100.0%) vs 97.8% (95% 93.5%-100.0%), =0.314]. Compared with standard adjuvant therapy, PCbH was related to less neutropenia and better cardiac safety. These results support the consideration of anthracycline-free neoadjuvant chemotherapy combined with anti-HER-2 therapy for patients with stages Ⅱ-Ⅲ HER-2-positive and HR-negative breast cancer. Optimized regimens with both efficacy and safety are needed and to be further investigated.
为提供无蒽环类药物新辅助化疗用于Ⅱ-Ⅲ期人表皮生长因子受体2（HER-2）阳性且激素受体（HR）阴性乳腺癌患者的生存证据。这项前瞻性队列研究在中国医学科学院肿瘤医院肿瘤内科开展。纳入Ⅱ-Ⅲ期HER-2阳性且HR阴性乳腺癌患者接受剂量密集型紫杉醇（175mg/m²）加卡铂（AUC=4.0）每2周1次共6个周期联合曲妥珠单抗的新辅助治疗（PCbH），并招募接受医生选择的标准辅助治疗的匹配患者进行生存和安全性比较。2013年7月至2019年11月，共纳入166例患者（新辅助治疗组51例，辅助治疗组115例）。与接受辅助治疗的患者相比，接受新辅助治疗的患者更年轻（<35岁：19.6%对5.2%，P=0.014），肿瘤更大（T3：62.7%对7.8%，P<0.001）且疾病更晚期（ⅡA期：2.0%对41.7%，P<0.001）。新辅助治疗组患者均接受了手术，辅助治疗组115例中有96例（83.5%）接受了含蒽环类和紫杉类的方案。共匹配了98例患者（49对），两组间协变量平衡良好。在中位随访46.5（范围14-87）个月时，接受新辅助治疗的患者4年无复发生存（RFS）率为73.3%（95%CI 59.0%-87.6%），辅助治疗组为80.6%（95%CI 67.9%-93.3%），差异无统计学意义（P=0.418）。4年总生存（OS）结果相似[新辅助治疗组对辅助治疗组：91.5%（95%CI 81.7%-100.0%）对97.8%（95%CI 93.5%-100.0%），P=0.3,14]。与标准辅助治疗相比，PCbH导致的中性粒细胞减少更少且心脏安全性更好。这些结果支持考虑对Ⅱ-Ⅲ期HER-2阳性且HR阴性乳腺癌患者采用无蒽环类药物新辅助化疗联合抗HER-2治疗。需要并有待进一步研究兼具疗效和安全性的优化方案。
