Background: There are no comparative trials between the two most common schemes in HER2-positive early breast cancer treatment; BERENICE (with anthracyclines) and TRAIN-2 (without anthracyclines). In this study, we investigated the pathological complete response (pCR) and safety events achieved with each.Methods: This analytical retrospective observational study included 111 patients with early and locally advanced HER-2-positive breast cancer who initiated neoadjuvant treatment with an anthracycline-based scheme (four cycles of doxorubicin and cyclophosphamide, followed by four cycles of taxane, trastuzumab, and pertuzumab = AC-THP) and a non-anthracycline scheme (carboplatin, weekly paclitaxel, trastuzumab, and pertuzumab for six–nine cycles = TCbHP) at the National Cancer Institute in Colombia, between April 2020 and December 2024. The primary endpoint was the pCR. Safety was analyzed in patients who received at least one treatment cycle.Results: A total of 51 patients received AC-THP and 60 TCbHP (89.6% of which received six cycles). The pCR was 58.3% in ACHTP and 60.4% in TCbHP (p= 0.84). As a descriptive analysis, with the anthracycline-based scheme, there was a trend toward a higher pCR in patients with T3-T4, positive nodal involvement (N+), and positive hormone receptor (HR+). Cardiac toxicity events during the neoadjuvant phase were 9.8% in ACTHP and 3.3% in TCbHP. Grade 2 neuropathy events were higher in patients with the TCbHP scheme, at 23.3%, versus 9.8% in ACTHP.Conclusions: We found similar pCR rates between the schemes with anthracyclines and without anthracyclines. It is still pertinent to discuss the risk–benefit of using anthracycline-based regimens in patients with HR+, T3-T4, and N+. The cardiac adverse events reported in our patients were similar to those reported in the BERENICE trial.
背景：在HER2阳性早期乳腺癌治疗中，两种最常用方案——含蒽环类药物的BERENICE方案与不含蒽环类药物的TRAIN-2方案——尚无对比性研究。本研究旨在探讨两种方案的病理完全缓解（pCR）率及安全性事件。 方法：本回顾性观察性分析研究纳入111例早期及局部晚期HER2阳性乳腺癌患者，均于2020年4月至2024年12月期间在哥伦比亚国家癌症研究所接受新辅助治疗。治疗方案分为含蒽环类方案（4周期多柔比星联合环磷酰胺序贯4周期紫杉类+曲妥珠单抗+帕妥珠单抗，即AC-THP）与不含蒽环类方案（卡铂+周疗紫杉醇+曲妥珠单抗+帕妥珠单抗治疗6-9周期，即TCbHP）。主要研究终点为pCR率，安全性分析纳入至少接受一个周期治疗的患者。 结果：共51例患者接受AC-THP方案，60例接受TCbHP方案（其中89.6%完成6周期治疗）。AC-THP组pCR率为58.3%，TCbHP组为60.4%（p=0.84）。描述性分析显示，在含蒽环类方案中，T3-T4分期、淋巴结阳性（N+）及激素受体阳性（HR+）患者呈现更高的pCR趋势。新辅助治疗期间心脏毒性事件发生率在AC-THP组为9.8%，TCbHP组为3.3%。2级神经病变事件在TCbHP组更高（23.3% vs AC-THP组9.8%）。 结论：含蒽环类与不含蒽环类方案显示出相似的pCR率。对于HR阳性、T3-T4分期及淋巴结阳性患者，仍需权衡含蒽环类方案的获益风险。本研究观察到的心脏不良事件发生率与BERENICE试验报道结果相似。
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