De-Shun Yao1, Wei Wang2, Jin-Yi Chang2, Yang Zhang1, Hui-Wen Zhang3, Jin-Xia Xu4, Hai-Feng Cai1. 1. Second Department of Breast Surgery, Tangshan People's Hospital, North China University of Science and Technology, Tangshan, China. 2. School of Clinical Medicine, North China University of Science and Technology, Tangshan, China. 3. College of Nursing and Rehabilitation, North China University of Science and Technology, Tangshan, China. 4. Nuclear Medicine Clinical Laboratory, Tangshan People's Hospital, North China University of Science and Technology, Tangshan, China.
Abstract
BACKGROUND: The anti-tumor activity of pyrotinib has been confirmed in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. This study investigated the effect of pyrotinib plus nab-paclitaxel, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with HER2-positive locally advanced breast cancer. METHODS: In this single-center retrospective study, female patients with HER2-positive locally advanced breast cancer received pyrotinib 320 mg orally once a day and the TAC regimen (nab-paclitaxel 260 mg/m2, liposomal doxorubicin 20 mg/m2, and cyclophosphamide 600 mg/m2) on day 1 of each 21-day cycle. Surgery was performed after 4-6 cycles of neoadjuvant therapy. The outcomes included total pathological complete response (tpCR, ypT0/Tis ypN0) rate, objective response rate (ORR) after neoadjuvant therapy, progression-free survival, overall survival, and the incidence of adverse events (AEs). RESULTS: Between March 2019 and January 2020, a total of 22 patients were included. The median age was 48 years (range, 32-60). The ORR was 100% after the completion of neoadjuvant therapy. Ten (45.5%) patients achieved tpCR, including four of ten (40.0%) patients with positive hormone receptor, and six of 12 (50.0%) patients with negative hormone receptor. As at December 2020, no disease recurrence, progression, or death occurred. All patients suffered AEs after neoadjuvant therapy, most of which were grade 1-2. Grade ≥3 AEs included diarrhea [4 (18.2%)], rash [2 (9.1%)], and hand-foot syndrome [1 (4.5%)]. CONCLUSIONS: Neoadjuvant pyrotinib combined with the TAC regimen showed promising clinical benefit in patients with HER2-positive locally advanced breast cancer, with an acceptable safety profile. 2021 Gland Surgery. All rights reserved.
BACKGROUND: The anti-tumor activity of pyrotinib has been confirmed in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. This study investigated the effect of pyrotinib plus nab-paclitaxel, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with HER2-positive locally advanced breast cancer. METHODS: In this single-center retrospective study, female patients with HER2-positive locally advanced breast cancer received pyrotinib 320 mg orally once a day and the TAC regimen (nab-paclitaxel 260 mg/m2, liposomal doxorubicin 20 mg/m2, and cyclophosphamide 600 mg/m2) on day 1 of each 21-day cycle. Surgery was performed after 4-6 cycles of neoadjuvant therapy. The outcomes included total pathological complete response (tpCR, ypT0/Tis ypN0) rate, objective response rate (ORR) after neoadjuvant therapy, progression-free survival, overall survival, and the incidence of adverse events (AEs). RESULTS: Between March 2019 and January 2020, a total of 22 patients were included. The median age was 48 years (range, 32-60). The ORR was 100% after the completion of neoadjuvant therapy. Ten (45.5%) patients achieved tpCR, including four of ten (40.0%) patients with positive hormone receptor, and six of 12 (50.0%) patients with negative hormone receptor. As at December 2020, no disease recurrence, progression, or death occurred. All patients suffered AEs after neoadjuvant therapy, most of which were grade 1-2. Grade ≥3 AEs included diarrhea [4 (18.2%)], rash [2 (9.1%)], and hand-foot syndrome [1 (4.5%)]. CONCLUSIONS: Neoadjuvant pyrotinib combined with the TAC regimen showed promising clinical benefit in patients with HER2-positive locally advanced breast cancer, with an acceptable safety profile. 2021 Gland Surgery. All rights reserved.
Entities:
Keywords:
Pyrotinib; breast cancer; chemotherapy; human epidermal growth factor receptor 2; neoadjuvant therapy
Authors: Dennis Slamon; Wolfgang Eiermann; Nicholas Robert; Tadeusz Pienkowski; Miguel Martin; Michael Press; John Mackey; John Glaspy; Arlene Chan; Marek Pawlicki; Tamas Pinter; Vicente Valero; Mei-Ching Liu; Guido Sauter; Gunter von Minckwitz; Frances Visco; Valerie Bee; Marc Buyse; Belguendouz Bendahmane; Isabelle Tabah-Fisch; Mary-Ann Lindsay; Alessandro Riva; John Crown Journal: N Engl J Med Date: 2011-10-06 Impact factor: 91.245