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Abstract：
OBJECTIVE: The randomized phase 2 Neo-peaks study examined usefulness of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) following docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) as compared with the standard TCbHP regimen. We previously reported that pCR rate after neoadjuvant therapy tended to be higher with TCbHP followed by T-DM1 + P. We conducted an exploratory analysis of prognosis 5 years after surgery.
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).
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).
摘要：
目的：与标准TCbHP方案相比，随机2期新峰研究检查了多西他赛+卡铂+曲妥珠单抗+帕妥珠单抗(T-DM1+P)后新辅助曲妥珠单抗(T-DM1+P)的有效性。我们先前报道，TCbHP和T-DM1+P在新辅助治疗后的pCR率倾向于更高。我们对术后5年的预后进行了探索性分析。
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）。
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）。
