曲妥珠单抗恩美曲妥珠单抗（T-DM1）+帕妥珠单抗（P）联合多西他赛+卡铂+曲妥珠单抗+帕妥珠单抗（TCbHP）新辅助治疗人表皮生长因子受体 2（HER2）阳性原发性乳腺癌的长期结果：随机 2 期 JBCRG20 研究（Neo-peaks）的结果。

Long-term outcomes of neoadjuvant trastuzumab emtansine + pertuzumab (T-DM1 + P) and docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP) for HER2-positive primary breast cancer: results of the randomized phase 2 JBCRG20 study (Neo-peaks).

机构信息

Department of Breast Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.

Department of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8550, Japan.

出版信息

Breast Cancer Res Treat. 2024 Aug;207(1):33-48. doi: 10.1007/s10549-024-07333-7. Epub 2024 May 20.

PURPOSE

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.

TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION

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).

目的

Neo-peaks 研究的随机 2 期临床试验比较了曲妥珠单抗-美坦新偶联物（T-DM1）+帕妥珠单抗（P）新辅助治疗加紫杉烷类药物+卡铂+曲妥珠单抗+帕妥珠单抗（TCbHP）方案作为标准 TCbHP 方案之后的有效性。我们之前报告称，新辅助治疗后，TCbHP 加 T-DM1 加 P 的 pCR 率更高。我们对术后 5 年的预后进行了探索性分析。

方法

TCbHP（6 个周期；A 组）、TCbHP（4 个周期）加 T-DM1 加 P（4 个周期；B 组）、T-DM1 加 P（4 个周期；C 组，应答者加 2 个周期）的新辅助治疗进行了比较。C 组 4 个周期后无应答者切换到基于蒽环类药物的方案。我们评估了 5 年无病生存率（DFS）、远处无病生存率（DDFS）和总生存率（OS）。

结果

203 例患者的数据（A、B、C 组分别为 50、52 和 101 例）进行了分析。组间 DFS、DDFS 或 OS 无显著差异。A、B、C 组的 5 年 DFS 率（95%CI）分别为 91.8%（79.6-96.8%）、92.3%（80.8-97.0%）和 88.0%（79.9-93.0%）。TCbHP 加 T-DM1 加 P 及 T-DM1 加 P 加应答指导的蒽环类药物加量治疗与 TCbHP 治疗的长期预后相似。