TCbHP与AC-THP方案新辅助治疗HER2阳性乳腺癌真实世界疗效和安全性比较

耿丹; 胡崇珠; 郝鑫; 宋瑞; 王久洁; 代颖; 蒲朋朋; 高建朝; 张亮; 刘娜; 张豪云; 冯志龙

doi:10.3971/j.issn.1000-8578.2023.22.1507

TCbHP与AC-THP方案新辅助治疗HER2阳性乳腺癌真实世界疗效和安全性比较

Real-world Efficacy and Safety Comparison of Neoadjuvant Treatment of HER2-positive Breast Cancer with TCbHP Versus AC-THP

摘要

摘要:
目的比较真实世界临床实践中TCbHP方案与AC-THP方案新辅助治疗HER2阳性乳腺癌患者的疗效、安全性和耐受性。
方法回顾性收集2019年6月1日-2021年12月31日在河北省各地市11家三级甲等医院接受TCbHP方案或AC-THP方案新辅助治疗并完成既定手术的HER2阳性乳腺癌患者病例资料, 比较两种方案的总体病理完全缓解(tpCR)率、3级以上不良事件发生率、既定治疗方案完成率。
结果共纳入110例患者, 其中TCbHP方案78例、AC-THP方案32例, 均采用3周方案。TCbHP组tpCR率高于AC-THP组, 差异无统计学意义(64.10% vs. 56.25%, P=0.441)。TCbHP组与AC-THP组的乳腺pCR率、腋窝pCR率差异无统计学意义(70.51% vs. 56.25%, P=0.150;78.21% vs. 84.38%, P=0.462)。探索性分析发现, HR阳性患者中TCbHP组的tpCR率显著高于AC-THP组(51.11% vs. 22.22%, P=0.036)。HR阴性患者中, AC-THP组的tpCR率有高于TCbHP组的趋势, 但差异无统计学意义(100% vs. 81.82%, P=0.088)。TCbHP组3级以上不良事件发生率略高于AC-THP组, 但差异无统计学意义(12.82% vs. 9.38%, P=0.753), 全组无死亡病例。TCbHP组和AC-THP组的人群既定方案完成率差异无统计学意义(92.31% vs. 90.63%, P=0.718)。
结论在真实世界的临床实践中, TCbHP方案和AC-THP方案新辅助治疗HER2阳性乳腺癌的疗效确切, 安全性、耐受性良好。两种方案的tpCR率无显著差别, AC-THP方案可考虑作为HER2阳性乳腺癌新辅助治疗的优选方案之一。

Abstract:
Objective To compare the efficacy, safety, and survivability of TCbHP versus AC-THP in the neoadjuvant therapy of HER2-positive breast cancer in real-world.
Methods Clinical data of patients with HER2 positive breast cancer, who have received TCbHP or AC-THP as neoadjuvant therapy and completed surgery in 11 third-class hospitals in various cities of Hebei Province, were retrospectively collected.The total pathological complete remission (tpCR) rate, the incidence of grade 3 or higher adverse reactions and the completion rate of the given approaches were compared.
Results A total of 110 cases were collected, including 78 cases in the TCbHP group and 32 cases in the AC-THP group.The tpCR rate of the TCbHP group was higher than that of the AC-THP group, but the difference was not statistically significant (64.10% vs. 56.25%, P=0.441).No significant difference was found in the breast pathologic complete response (bpCR) and axillary pathologic complete response (apCR) rates between the TCbHP group and the AC-THP group (70.51% vs. 56.25%, P=0.150;78.21% vs. 84.38%, P=0.462).Exploratory analysis revealed that the tpCR rate of the TCbHP group was significantly higher than that of the AC-THP group in patients with HR-positive breast cancer (51.11% vs. 22.22%, P=0.036).As for the patients with HR-negative breast cancer, the tpCR rate of the AC-THP group tended to be higher than that of the TCbHP group (100% vs. 81.82%, P=0.088).The incidence of grade 3 or higher adverse reactions in the TCbHP group was slightly higher than that in the AC-THP group (12.82% vs. 9.38%, P=0.753).No deaths occurred in the whole group.Moreover, no significant difference was observed in the completion rate of the given approaches between the TCbHP group and the AC-THP group (92.31% vs. 90.63%, P=0.718).
Conclusion In real-world clinical practice, the neoadjuvant therapy of TCbHP and AC-THP are effective, safe, and well tolerated among patients with HER2-positive breast cancer.The tpCR rate between the two approaches was not significantly different.The AC-THP regimen could also be considered as one of the optimal regimens for HER2-positive breast cancer in neoadjuvant therapy.

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