| Objective:To evaluate the effectiveness and safety of trastuzumab emtansine(T-DM1)in treating patients with human epidermal growth factor receptor 2(HER2)positive breast cancer.Method:We systematically looked through the databases of Pub Med,Embase,Cochrane Library,CNKI,Wanfang Data,and Vipshop for randomized controlled trials on T-DM1 for HER2-positive breast cancer up to 03/24/2022.T-DM1-containing treatment regimens served as the experimental group in this study,whereas other treatment regimens that did not contain T-DM1 served as the control group.The study endpoints were overall survival(OS),progression free survival(PFS),pathological complete response(p CR)rate,overall response rate(ORR),3-year invasive disease-free survival(i DFS)rate,adverse events(AEs)and the incidence of various adverse events(≥ grade 3).The hazard ratio(HR)and the corresponding 95% confidence interval(CI)were used as the effect indicators for time events.The odds ratio(OR)or relative risk(RR)and the corresponding 95% confidence interval(CI)were used as effect indicators for dichotomous variables.Meta-analysis,publication bias analysis and sensitivity analysis were performed on the data using STATA12.0 and Revman 5.3 software.Results:A total of 15 RCTs were retrieved,with 9,676 patients participating.According to the results of the efficacy analysis,T-DM1 significantly increased the p CR rate in patients with early-stage breast cancer that was HER2-positive when compared to other treatment regimens in neoadjuvant therapy(OR=1.35,95% CI: [1.02,1.79],P=0.035).Subgroup analysis showed that T-DM1 significantly increased the p CR rate compared to single-target therapy(OR=2.59,95% CI: [1.92,3.50],P<0.001),but no significant difference was seen compared to dual-target therapy(OR=1.03,95% CI: [0.86,1.25],P=0.741).When compared to alternative treatment plans,the 3-year i DFS rate was not higher when T-DM1 was used as post-operative adjuvant therapy after neoadjuvant therapy for patients with early-stage breast cancer that was HER2-positive.When compared to alternative treatment plans,the use of T-DM1 in the intensive adjuvant phase did not increase the 3-year i DFS rate in HER2-positive breast cancer patients with postoperative residual disease.In patients with HER2-positive advanced breast cancer,T-DM1 resulted in a statistically significant prolongation of PFS(HR=0.71,95% CI: [0.57,0.88],P<0.001)and OS(HR=0.78,95% CI:[0.70,0.87],P<0.001),but did not improve ORR.Subgroup analysis showed that T-DM1 was able to prolong PFS(HR=0.60,95%CI: [0.49,0.73],P<0.001)and OS(HR=0.68,95%CI: [0.58,0.80],P<0.001)in patients as a non-first-line treatment,but no significant difference was seen as a first-line treatment.Safety analysis revealed that the overall adverse event rate was not significantly different between the T-DM1-containing experimental group and the control group(RR=1.00,95% CI: [0.98,1.02],P=0.887).However,the rate of grade ≥3 adverse events was not increased in the T-DM1-containing group compared to the control group,and the difference between the two groups was statistically significant(RR=0.66,95% CI: [0.53,0.83],P<0.001).Conclusions:(1)T-DM1 could be utilized as a neoadjuvant treatment for patients with HER2 positive early breast cancer.(2)T-DM1 might increase PFS and OS while not enhancing ORR in HER2-positive advanced breast cancer patients.(3)T-DM1 had a good safety profile with no increased incidence of grade 3 or higher adverse events compared to other regimens in HER2-positive breast cancer. |
PDF Full Text Request