The results of EMILIA phase III study ( number: NCT00829166) indicated that T-DM1 significantly prolonged the progression-free survival (PFS) (9.6 vs. T-DM1 has shown its efficacy both in early-stage and advanced-stage HER2+ BC ( 9, 17). T-DM1 is a first-in-class antibody-drug conjugate consisting of Tra linked to an anti-tubulin agent DM1, via a stable thioether linker ( 16). Therefore, it is of necessity and interest to identify the potential best anti-HER2 regimen in later treatment lines of HER2+ MBC. On the other hand, there are controversies in choosing which anti-HER2 regimen for HER2+ patients who progressed on prior treatment of Tra and a taxane ( 15). Despite all the advances in targeted therapy, the resistance to anti-HER2 treatment remains a major challenge ( 14). In addition to Tra, numerous novel agents including trastuzumab emtansine (T-DM1 Kadcyla™, Roche), pertuzumab (Per Perjeta™, Roche), lapatinib (Lap Tyverb™, GlaxoSmithKline), neratinib (Ner Nerlynx™, Puma Biotechnology), and pyrotinib (Pyr HengRui) have been introduced in recent years ( 9– 13). The administration of Tra either in combination with chemotherapy or in monotherapy has significantly improved the disease-free and overall survival (OS) of patients in the neo/adjuvant treatment phase, as well as in the rescue treatment for advanced/metastatic BC (MBC) ( 6– 8). ![]() The first FDA-approved HER2-targeted agent, trastuzumab (Tra Herceptin™, Roche), started the new era of targeted therapy of BC. Positive HER2 is a risk factor for BC patients, which is reflected in the aggressive clinical phenotype and poor prognosis for HER2+ BC patients ( 5). The HER2 is a receptor tyrosine-protein kinase and amplified in 15–30% of all human BC ( 4). According to the molecular landscape of the tumor, BC is divided into four subtypes including luminal A, luminal B, human epidermal growth factor receptor 2-positive (HER2+), and triple-negative BC ( 3). However, it may be associated with more grade ≥3 AEs.īreast cancer (BC), a highly heterogeneous disease, currently represents the most common cancer in females with over million new cases confirmed per year worldwide ( 1, 2). Pyr-Cap ranked in the highest in PFS, OS, ORR, and grade ≥3 AEs (SUCRA = 99.4, 89.7, 86.4, and 89.3%).Ĭonclusions: These results indicate that Pyr may be more effective than T-DM1 in HER2+ MBC patients pre-treated with Tra and a taxane. No significant difference was observed in grade ≥3 AEs among all the regimens. For ORR, Pyr-Cap was significantly superior than Cap (odds ratio, 95% confidence interval: 7.87, 1.22–56.51). Nine regimens were included into the network: T-DM1, lapatinib-capecitabine (Lap-Cap), Tra-Cap, Cap, neratinib (Ner), pertuzumab (Per)-Tra-Cap, Pyr-Cap, atezolizumab (Ate)-T-DM1, and Ner-Cap. Results: Twelve studies with 4,353 subjects were identified. Values of surface under cumulative ranking probability curve (SUCRA) were calculated to offer a ranking of all regimens. A fixed effects network meta-analysis based on the Bayesian inferential framework was conducted for progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and grade ≥3 adverse events (AEs). ![]() Randomized clinical trials comparing the efficacy and safety between different anti-HER2 regimens in patients pre-treated with trastuzumab (Tra) and a taxane in metastatic settings (≤second-line treatment) were included. Methods: A comprehensive literature search of the PubMed, EMBASE, and Web of Science was performed in August 2020. Purpose: To compare the efficacy and safety between pyrotinib (Pyr) and trastuzumab emtansine (T-DM1) in pre-treated human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) patients. 3Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology and Key Laboratory of Assisted Reproduction, Ministry of Education, Peking University Third Hospital, Beijing, China.2Department of Hematology-Oncology, International Cancer Center, Shenzhen University General Hospital, Shenzhen University Health Science Center, Shenzhen, China.1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing, China.Hao Liao 1†, Wenfa Huang 2†, Yaxin Liu 1, Wendi Pei 3 and Huiping Li 1*
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