![]() ![]() ![]() Our data support the use of Q-RT-PCR for testing breast cancer specimens to select patients for HER2 inhibitory therapy. Cost analysis documented the advantage of Q-RT-PCR in all US Food and Drug Administration–approved assays. The intermediate immunohistochemical group (2+), including FISH+ and FISH– cancers, could also be stratified by Q-RT-PCR. There was complete concordance between Q-RT-PCR and immunohistochemical results for negative and strongly positive (3+) cases. HER2 messenger RNA levels were significantly stratified in agreement with immunohistochemical data ( P <. Q-RT-PCR provided reliable data in frozen and FFPE specimens, which were significantly correlated. Costs of techniques were calculated to study 1 case and 10 or 40 cases. Immunohistochemical and FISH analyses were performed on individual slides and on tissue microarray. We evaluated 44 frozen and 55 formalin-fixed paraffin-embedded (FFPE) breast carcinoma specimens by Q-RT-PCR, immunohistochemical analysis, and fluorescent in situ hybridization (FISH). doi:10.1200/JCO.2021.39.15_suppl.We performed a technical and cost-effectiveness analysis of quantitative reverse transcription–polymerase chain reaction (Q-RT-PCR) for the assessment of HER2 in breast cancer. Pyrotinib as neoadjuvant therapy for HER2+ breast cancer: a multicenter, randomized controlled phase II trial. In the control group, 18 patients (55%) were older than 50, 15 patients (45%) were 50 or younger 30 patients (91%) showed a tumor size of >2 cm, 3 patients (9%) ≤2 cm 21 patients (64%) had about 1 to 2 positive nodes, 9 (27%) had about 3 to 4 positive nodes, and 3 (9%) were node negative and 17 patients (52%) had negative HR status, 16 patients (48%) reported positive. Their hypothesis proved true with the total pCR rate in the treatment group measuring 71.4% (15/21) versus 36.7% (11/30) in the control group a significant difference was found between the 2 groups ( P 2 cm, 5 patients (15%) ≤2 cm 22 patients (64%) had about 1 to 2 positive lymph nodes, 6 (18%) had about 3 to 4, and 6 (18%) were node negative and 21 patients (62%) had a negative hormone receptor (HR) status, while 13 patients (38%) were positive for HR. Investigators hypothesized that patients treated in the investigational group (pyrotinib+TCbH) could have a higher pCR rate than the control group (TCbH). In certain cancers, especially breast cancer, the HER2 gene mutates (changes) and makes extra. Genes are the basic units of heredity, passed down from your mother and father. It is a gene that makes a protein found on the surface of all breast cells. Secondary end points included toxicity, event-free survival, disease-free survival, distant disease-free survival, and objective response rate (ORR).įrom 2019 to 2021, 67 patients with HER2-positive breast cancer were randomized equally into the treatment and control groups. HER2 stands for human epidermal growth factor receptor 2. pCR, the primary end point, was defined in the study as no invasive or in situ disease in the breast or axilla. The randomized, double-blind multicenter study evaluated the efficacy and safety of the addition of pyrotinib, an irreversible second-generation HER2-targeted tyrosine kinase inhibitor (TKI), to TCbH versus TCbH alone given as neoadjuvant treatment in patients with stage II-III HER2-positive breast cancer and invasive carcinoma. “In this study, TCbH plus pyrotinib neoadjuvant therapy significantly improved the total pCR rate of HER2-positive breast cancer patients for about twice TCbH with a manageable safety ,” the study authors, led by Xiaowen Ding, MD, of the Department of Breast Surgery, Zhejiang Cancer Hospital in Hangzhou, China, wrote in their poster. The combination of pyrotinib plus trastuzumab (Herceptin), docetaxel, and carboplatin (TCbH) significantly improved the total pathological complete response (pCR) rate over TCbH alone in the neoadjuvant treatment of patients with HER2-positive breast cancer, according to data from a phase 2 trial (NCT03756064) presented during the 2021 ASCO Annual Meeting. ![]()
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