Arnau de Vilanova Hospital, Valencia, Spain.
Medica Scientia Innovation Research (MEDSIR)-Oncoclínicas and Co., Jersey City, New Jersey, Sao Paulo, Brazil.
Clin Cancer Res. 2024 Sep 13;30(18):4123-4130. doi: 10.1158/1078-0432.CCR-24-0464.
The purpose of this study was to assess the predictive capability of HER2DX assay following (neo)adjuvant trastuzumab-pertuzumab (HP)-based therapy in HER2-positive (HER2+) early breast cancer.
HER2DX was analyzed in baseline pretreatment tumors from the PHERGain trial. Patients with stage I-IIIA HER2+ early breast cancer were randomized to group A [docetaxel, carboplatin, and HP (TCHP)] and group B (HP ± endocrine therapy). PET response was evaluated after two cycles. Group A received TCHP for six cycles regardless of PET response. Group B continued with HP ± endocrine therapy for six cycles (PET responders) or with TCHP for six cycles (PET nonresponders). The primary objective of this retrospective study was to associate the HER2DX pathologic complete response (pCR) score with pCR. The secondary objective was the association of the HER2DX risk score with 3-year invasive disease-free survival (iDFS).
HER2DX was performed on 292 (82.0%) tumors. The overall pCR rate was 38.0%, with pCR rates of 56.4% in group A and 33.8% in group B. In multivariable analysis including treatment and clinicopathologic factors, the HER2DX pCR score (continuous variable) significantly correlated with pCR [OR, 1.29; 95% confidence interval (CI), 1.10-1.54; P < 0.001]. HER2DX-defined pCR-high, -med, and -low groups exhibited pCR rates of 50.4%, 35.8%, and 23.2%, respectively (pCR-high vs. pCR-low OR, 3.27; 95% CI, 1.54-7.09; P < 0.001). In patients with residual disease, the HER2DX high-risk group demonstrated numerically worse 3-year iDFS than the low-risk group (89.8% vs. 100%; HR, 2.70; 95% CI, 0.60-12.18; P = 0.197).
HER2DX predicts pCR in the context of neoadjuvant HP-based therapy, regardless of chemotherapy addition, and might identify patients at higher risk of recurrence among patients with residual disease.
本研究旨在评估在曲妥珠单抗-帕妥珠单抗（HP）新辅助治疗后，HER2DX 检测在 HER2 阳性（HER2+）早期乳腺癌中的预测能力。
在 PHERGain 试验的基线预处理肿瘤中分析了 HER2DX。将 I 期-IIIA 期 HER2+早期乳腺癌患者随机分为 A 组（多西他赛、卡铂和 HP（TCHP））和 B 组（HP ± 内分泌治疗）。在两个周期后评估 PET 反应。A 组无论 PET 反应如何，均接受 TCHP 治疗 6 个周期。B 组继续接受 HP ± 内分泌治疗 6 个周期（PET 应答者）或 TCHP 治疗 6 个周期（PET 无应答者）。这项回顾性研究的主要目的是将 HER2DX 病理完全缓解（pCR）评分与 pCR 相关联。次要目的是将 HER2DX 风险评分与 3 年无侵袭性疾病生存（iDFS）相关联。
对 292 例（82.0%）肿瘤进行了 HER2DX 检测。总 pCR 率为 38.0%，A 组为 56.4%，B 组为 33.8%。在包括治疗和临床病理因素的多变量分析中，HER2DX pCR 评分（连续变量）与 pCR 显著相关[比值比，1.29；95%置信区间（CI），1.10-1.54；P < 0.001]。根据 HER2DX 定义的 pCR-高、pCR-中、pCR-低组的 pCR 率分别为 50.4%、35.8%和 23.2%（pCR-高与 pCR-低比值比，3.27；95%CI，1.54-7.09；P < 0.001）。在有残留疾病的患者中，HER2DX 高危组的 3 年 iDFS 率明显低于低危组（89.8%比 100%；风险比，2.70；95%CI，0.60-12.18；P = 0.197）。
HER2DX 预测了新辅助 HP 治疗背景下的 pCR，无论是否添加化疗，并且可能在残留疾病患者中识别出复发风险较高的患者。
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