METHODS: Neoadjuvant treatment with TCbHP (6 cycles; group A), TCbHP (4 cycles) followed by T-DM1 + P (4 cycles; group B), and T-DM1 + P (4 cycles; group C, + 2 cycles in responders) were compared. Group C non-responders after 4 cycles were switched to an anthracycline-based regimen. We evaluated 5-year disease-free survival (DFS), distant DFS (DDFS), and overall survival (OS).
RESULTS: Data from 203 patients (50, 52, and 101 in groups A-C, respectively) were analyzed. No significant intergroup differences were found for DFS, DDFS, or OS. The 5-year DFS rates (95% CI) were 91.8% (79.6-96.8%), 92.3% (80.8-97.0%), and 88.0% (79.9-93.0%) in groups A-C, respectively. TCbHP followed by T-DM1 + P and T-DM1 + P with response-guided addition of anthracycline therapy resulted in similar long-term prognosis to that of TCbHP.
CONCLUSIONS: In patients who achieved pCR after neoadjuvant therapy with T-DM1 + P, omission of adjuvant anthracycline may be considered, whereas treatment should be adjusted for non-pCR patients with residual disease. T-DM1 + P with response-guided treatment adjustment may be useful for minimizing toxicity.
UNASSIGNED: UMIN-CTR, UMIN000014649, prospectively registered July 25, 2014. Some of the study results were presented as a Mini Oral session at the ESMO Breast Cancer 2023 (Berlin, Germany, 11-13 May 2023).
方法:新辅助治疗TCbHP(6个周期;A组),TCbHP(4个周期),随后T-DM1+P(4个周期;B组),T-DM1+P(4个周期;C组,+2个周期的应答者)进行比较。4个周期后,C组无反应者改用基于蒽环类的方案。我们评估了5年无病生存期(DFS),远程DFS(DDFS),总生存率(OS)。
结果:数据来自203名患者(A-C组的50、52和101,分别)进行了分析。DFS没有发现显著的组间差异,DDFS,或操作系统。5年DFS率(95%CI)为91.8%(79.6-96.8%),92.3%(80.8-97.0%),A-C组88.0%(79.9-93.0%),分别。TCbHP随后是T-DM1P和T-DM1P,并在反应指导下增加蒽环类药物治疗,其长期预后与TCbHP相似。
结论:在T-DM1+P新辅助治疗后达到pCR的患者中,可以考虑省略蒽环类佐剂,而对于有残留疾病的非pCR患者,应调整治疗方法。具有响应指导的治疗调整的T-DM1+P可用于最小化毒性。
■UMIN-CTR,UMIN000014649,2014年7月25日预期注册。一些研究结果在ESMO乳腺癌2023年的小型口头会议上发表(柏林,德国,2023年5月11日至13日)。