Abstract
ObjectiveTo explore the correlation between HER-2 status and pathological complete response (pCR) in HER-2-positive breast cancer after dual anti-HER-2 neoadjuvant therapy with trastuzumab and pertuzumab.MethodsA total of 57 HER-2-positive breast cancer patients admitted to the Second Affiliated Hospital of Anhui Medical University and Xijing Hospital Affiliated to Air Force Military Medical University, between January 1, 2019 and September 30, 2020, were enrolled in this multicenter retrospective study. HER-2 status, including HER-2/CEP17 ratio and HER-2/cell number ratio, was detected by FISH. The correlation between HER-2 status/clinicopathological data and pCR was analyzed. The ROC curve was drawn to determine the cutoff value.ResultsIHC assessment revealed 40 (70.18%) patients with IHC 3+ and 17 (29.82%) with IHC 2+. 41/57 (71.93%) patients achieved pCR. FISH revealed that the ratio of HER-2/chromosome 17 centromere (HER-2/CEP17) (p<0.001) and the ratio of HER-2/cell number (p<0.001) was significantly correlated with the pCR rate. ROC analysis showed that patients with an HER-2/CEP17 ratio ≥4.495 or HER-2/cell number ≥11.650 have a high pCR rate after dual anti-HER-2 neoadjuvant therapy, suggesting its predictive significance.ConclusionThe response to dual-targeted neoadjuvant therapy with trastuzumab and pertuzumab was adequate in hormone receptor-negative, HER-2-positive breast cancer patients. HER-2/CEP17 ratio and HER-2/cell number ratio were crucial for predicting efficacy.
Highlights
Breast cancer has replaced lung cancer as the world’s most common malignant tumor that severely endangers women’s health [1]
In the NeoSphere study, the pathological complete response (pCR) rate of trastuzumab combined with pertuzumab combined with docetaxel was significantly higher than that in the single-target group [9]
In terms of chemotherapy regimen, 36/57 (63.16%) patients received anthracycline combined with taxane regimen [A(E)C-T/T-A(E)C], 11 (19.30%) patients received taxane combined with carboplatin regimen (TCb), and 10 (17.54%) patients received single taxane regimen (T) treatment
Summary
Breast cancer has replaced lung cancer as the world’s most common malignant tumor that severely endangers women’s health [1]. Human epidermal growth factor receptor-2 (HER2)-positive breast cancer accounts for 20–25% of all breast carcinomas and has a poor prognosis and high recurrence rate [2]. The development of the HER-2-targeting antibody has profoundly improved the outcome in HER-2-positive breast cancers [3]. As monoclonal anti-HER-2 drugs, trastuzumab and pertuzumab, act on two different domains of HER-2, respectively, and synergistically inhibit HER-2-positive breast cancer [4–8]. In the NeoSphere study, the pCR rate of trastuzumab combined with pertuzumab (dual anti-HER-2 therapy) combined with docetaxel was significantly higher than that in the single-target group [9]. Despite the improvement of 45.8%, more than 50% of patients did not achieve pCR. Screening patients with high drug sensitivity before neoadjuvant therapy is crucial in HER-2-positive breast cancer patients
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