To evaluate the efficacy and safety of pyrotinib in the neoadjuvant therapy of HER-2-positive early or locally advanced breast cancer.

The databases including China National Knowledge Infrastructure(CNKI), Wanfang Data, VIP Med Online, SinoMed, PubMed, Embase and Cochrane Library were searched for the literatures on pyrotinib in the neoadjuvant therapy of HER-2-positive early or locally advanced breast cancer. The retrieval period was from the establishment of the database to February 9, 2022. The quality of the research was assessed according to the Cochrane Review Handbook 5.1.0. The objective response rate, total pCR rate and incidence of adverse events (such as diarrhea) were parameters to be extracted from the literature. Revman 5.4.1 software was used for data extraction and quantitative synthesis in the studies that met the quality assessment criteria. Random effect model or fixed effect model was utilized depending on the heterogeneity.

Four trials were enrolled, including 554 patients. Totally 278 patients received pyrotinib combined with chemotherapy and 276 patients received chemotherapy alone. The results of meta-analysis revealed that compared with chemotherapy alone, pyrotinib combined with chemotherapy significantly improved the objective response rate (RR=1.15, 95%CI: 1.07-1.24, P<0.001) and total pCR rate(RR=1.90, 95%CI: 1.45-2.50, P<0.001). As for adverse events, the incidence of grade 3 or above diarrhea (RR=7.67, 95%CI: 4.38-13.45, P<0.001) and the incidence of diarrhea of any grade(RR=5.62, 95%CI: 3.95-8.00, P<0.001) in combined therapy group were significantly increased compared with chemotherapy, but there was no significant difference in the incidence of leucopenia (RR=1.02, 95%CI: 0.87-1.21, P=0.790), thrombocytopenia (RR=1.00, 95%CI: 0.70-1.43, P=0.990), nausea/vomiting(RR=1.30, 95%CI: 1.00-1.68, P=0.050) and hand-foot syndrome(RR=1.46, 95%CI: 0.75-2.86, P=0.270) between two groups.

For patients with HER-2-positive early or locally advanced breast cancer, the neoadjuvant regimen of pyrotinib combined with chemotherapy can significantly improve the objective response rate and total pCR rate, and increase the risk of grade 3 or above diarrhea. In clinical practice, attention should be paid to the management of adverse events such as diarrhea, so as to ensure the efficacy and improve the quality of life.