Abstract
Background: Trastuzumab has been proved to reduce recurrence and death of Her-2 positive early breast cancer patients. However, the definition of Her-2 positive remains controversial and mutable. The recommendations promoted by ASCO/CAP changed frequently during decades. Although information is available regarding Her2 status and trastuzumab use in the western countries, no related research have been conducted in China to explore the Her-2 status and the utilization of HER2-targeted therapies.Methods: We analysed data from 1,227 patients with histologically proven breast cancer operated in PUMCH from June 2007 to July 2017.There were 1,227 patients with histologically proven Her 2 IHC 2+ breast cancer enrolled in our study. The clinicopathological features, recurrence-free survival (RFS), distant recurrence free survival (DRFS), disease free survival (DFS) and overall survival (OS) were compared among subgroups. Prognostic factors of RFS, DRFS, DFS and OS were identified.Results: Among groups,there was no significant difference in Tumor histology, pT, pTNM stage, Histological grade, Focality, Lymphovascular invasion (LVI), ER, PR, Her2 and Ki67 high (defined as ≥14%) ，surgery of breast，surgery of axilla，percentage of patients who needed chemotherapy, radiation therapy and endocrine therapy. There were significant difference both in the mean age of diagnosis (P=0.005) and different age groups (P=0.003). There was no significant difference in RFS or OS among five groups and between any two groups. There was no significant difference in DRFS and DFS between Group 1 and Group 2 (P=0.011 and P=0.008). According to univariate analyses and Cox multivariate analyses, RFS prognostic factor included pT, LVI and surgery of axilla, pT, pN and ER status were DRFS factors. DFS prognostic factor included pT, pN and PR status. Age at diagnosis, histological type, pT, pN and ER status were prognostic factors of OS.Conclusions: Our study revealed that, according to ASCO/CAP guideline in 2018, compared to patients with HER2-to-CEP17 ratio＜2.0 and average Her2 copy number ＜4.0/tumor cell, the patients with HER2-to-CEP17 ratio＜2.0 and average Her2 copy number ≥4.0 and ＜6/tumor cell showed worse DFS and DRFS. Changing Her2 status of patients with HER2-to-CEP17 ratio＜2.0 and average Her2 copy number ≥4.0 and ＜6/tumor cell from Her2 equivocal to negative seemed not so reasonable.
Changes in identification of Her2 status according to 2018 College of American Pathologists/American Society of Clinical Oncology (CAP/ASCO) guideline recommendations for human epidermal growth factor receptor 2 (HER2) fluorescent in situ hybridization (FISH) testing: A real-world study based on consecutive hospital cohort of patients with Her2 IHC 2+ in China (2007-2017)
