紫杉醇 +卡铂密集化疗联合曲妥珠单抗新辅助治疗对比标准辅助治疗对人表皮生 长 因 子 受 体 2 阳 性 且 激 素 受 体 阴 性乳腺癌患者生存影响的前瞻性研究

Objective 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. Methods 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 / m² ) 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. Results 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%, P = 0. 014), had larger tumors (T3: 62.7% vs 7.8%, P<0.001) and more advanced diseases (stage ⅡA: 2.0% vs 41.7%, P<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% CI: 59.0%⁃87.6%), versus 80.6% (95% CI: 67.9%⁃93.3%) among those in the adjuvant group without statistical difference (P = 0.418). A similar result was observed for the 4⁃year overall survival (OS) [ neoadjuvant versus adjuvant: 91. 5% (95% CI: 81. 7%⁃100. 0%) vs 97. 8% (95% CI: 93. 5%⁃ 100.0%), P = 0.314]. Compared with standard adjuvant therapy, PCbH was related to less neutropenia and better cardiac safety. Conclusions 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.