Department of Breast and Endocrine Surgery, Osaka Breast Clinic, Osaka, Japan.
First Research Department, Tazuke Kofukai Medical Research Institute, Osaka, Japan.
Oncology. 2022;100(5):257-266. doi: 10.1159/000522384. Epub 2022 Feb 3.
De-escalation therapy omitting anthracycline has been generally adopted for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the adjuvant setting, but not in the neoadjuvant chemotherapy (NAC) setting. We investigated whether anthracycline can be omitted in HER2-positive early breast cancer patients receiving neoadjuvant taxane plus trastuzumab with clinical response.
HER2-positive primary breast cancer patients treated using NAC containing trastuzumab were enrolled between September 2006 and July 2018 at Osaka Breast Clinic. The primary outcome was disease-free survival (DFS). The secondary outcome was overall survival (OS). We investigated survival with or without fluorouracil, epirubicin, and cyclophosphamide (FEC) using the log-rank test and propensity score matching (PSM).
In total, 142 patients were retrospectively included and median follow-up was 61 months. There was no significant difference in DFS (p = 0.93) and OS (p = 0.46) between the FEC-omitted group and the FEC-added group. The 5-year DFS was 91% and 88% and OS was 100% and 100%, respectively. After PSM, the FEC-omitted group and the FEC-added group had no significant differences in DFS (p = 0.459) and there were no death events in either group. The 5-year DFS was 90% and 88% and OS was 100% and 100%, respectively.
Using PSM, the 5-year DFS of HER2-positive early breast cancer was not different with or without anthracycline. Response-guided omission of anthracycline may be an option for HER2-positive early breast cancer patients receiving neoadjuvant taxane and trastuzumab with good response in order to avoid overtreatment.
在辅助治疗环境中，对于人表皮生长因子受体 2（HER2）阳性早期乳腺癌患者，通常采用不使用蒽环类药物的降阶梯治疗，但在新辅助化疗（NAC）环境中并非如此。我们研究了在接受曲妥珠单抗联合紫杉烷新辅助化疗且临床反应良好的 HER2 阳性早期乳腺癌患者中是否可以省略蒽环类药物。
2006 年 9 月至 2018 年 7 月，在大阪乳腺诊所入组接受曲妥珠单抗新辅助化疗的 HER2 阳性原发性乳腺癌患者。主要终点为无病生存（DFS）。次要终点为总生存（OS）。我们使用对数秩检验和倾向评分匹配（PSM）来研究有无氟尿嘧啶、表柔比星和环磷酰胺（FEC）的生存情况。
共回顾性纳入 142 例患者，中位随访时间为 61 个月。FEC 省略组与 FEC 添加组在 DFS（p = 0.93）和 OS（p = 0.46）方面无显著差异。5 年 DFS 分别为 91%和 88%，OS 分别为 100%和 100%。PSM 后，FEC 省略组和 FEC 添加组在 DFS 方面无显著差异（p = 0.459），且两组均无死亡事件。5 年 DFS 分别为 90%和 88%，OS 分别为 100%和 100%。
使用 PSM，HER2 阳性早期乳腺癌的 5 年 DFS 与是否使用蒽环类药物无关。对于接受紫杉烷和曲妥珠单抗新辅助化疗且反应良好的 HER2 阳性早期乳腺癌患者，基于反应的蒽环类药物省略可能是一种选择，以避免过度治疗。
