Efficacy and Safety of Neoadjuvant Pyrotinib for Human Epidermal Receptor 2-Positive Breast Cancer: A Meta-Analysis.

Neoadjuvant pyrotinib shows the potential to improve treatment response in human epidermal receptor 2 (HER2)-positive breast cancer patients, but relevant meta-analyses are scarce. This meta-analysis intended to explore the efficacy and safety of neoadjuvant pyrotinib for HER2-positive breast cancer patients. Studies comparing the efficacy and safety between HER2-positive breast cancer patients receiving pyrotinib-containing neoadjuvant treatment (pyrotinib group) and those receiving other neoadjuvant treatments (control group), were searched in EMBASE, Web of Science, Cochrane, PubMed, China National Knowledge Infrastructure, Wanfang, and SinoMed until December 2023. Six randomized controlled trials (RCTs) and 4 cohort studies were included. The pyrotinib group and control group contained 540 and 684 patients, respectively. Pathological complete response (pCR) was higher in the pyrotinib group than in the control group [relative risk (RR)=1.93; 95% confidence interval (CI) = 1.63-2.29; P < 0.001]. Similar results were discovered in subgroup analyses of RCTs (RR = 1.89; 95% CI = 1.49-2.40; P < 0.001) and cohort studies (RR = 1.98; 95% CI = 1.55-2.53; P < 0.001). The objective response rate (ORR) was also higher in the pyrotinib group than in the control group (RR = 1.14; 95% CI = 1.07-1.21; P < 0.001). Regarding adverse events, only the incidence of diarrhea was increased in the pyrotinib group versus the control group (RR = 1.97; 95% CI = 1.31-2.96; P = 0.001), while others were not different, including nausea and vomiting, leukopenia, thrombocytopenia, hand-foot syndrome, and alopecia (all P > 0.05). No publication bias existed, and sensitivity analysis suggested the satisfactory robustness of this meta-analysis. In conclusion, compared with other neoadjuvant treatments, pyrotinib-containing neoadjuvant treatment achieves a better treatment response with a good safety profile in HER2-positive breast cancer patients.