| Trastuzumab is the first monoclonal antibody against Her-2,which is beneficial to the survival of patients with early-stage breast cancer receiving postoperative adjuvant therapy or with advanced-stage ones receiving rescue therapy.This study retrospectively analized the clinical data of the patients receiving postoperative adjuvant chmotherapy or first-line chmotherapy whose immunohistochemical results showed Her-2(+++)or Her-2(++)and FISH gene detection revealed amplification in our hospital from2008.01 to 2018.01 A total of 181 patients underwent adjuvant therapy,and 84 patients received adjuvant chemotherapy plus trastuzumab.97 cases received adjuvant chemotherapy alone.There were 61 cases of advanced recurrence first-line treatment,32 cases of first-line treatment with trastuzumab,and 29 cases of chemotherapy alone.Tumor response was evaluated by response evaluation criteria in solid tumors(RECIST1.1): ORR,DCR,DFS,PFS,OS.This article aims to analyze the relationship between adjuvant chemotherapy,metastatic site,baseline CA153 level,medication interval and curative effect of trastuzumab,and cardiotoxicity in adjuvant and first-line treatment.Statistical analysis was performed using the Kaplan-Melen method,Log-rank test,chi-squra test,and Fisher exact probability method.RESULTS: Among the adjuvant treatment group: 1.A total of 84 patients received adjuvant chemotherapy and trastuzumab targeted therapy,97 patients received adjuvant chemotherapy alone,and 13patients(15.5%)in the trastuzumab group underwent recurrence and metastasis.In the chemotherapy group,49 patients(50.5%)underwent recurrence and metastasis.The median overall survival time was 98 months / 84 months,respectively.The difference was statistically significant.The results showed that compared with adjuvant chemotherapy alone,trastuzumab combined with adjuvant chemotherapy can significantly benefit patients with OS.2.There were 12 patients(14.3%)in the trastuzumab group with high CA153 level as baseline,and 5 patients underwent recurrence and metastasis after adjuvant therapy,4 of which were visceral metastases,1was bone metastasis.The median DFS was 26 months in the higher CA153 group.The median DFS could not be calculated because the number of relapsed cases was less than50%.The median OS was 98 months and 85 months,respectively.The difference was statistically significant,suggesting the efficacy is better in the normal CA153 group.3.In the trastuzumab group,16 patients(19%)had abnormal electrocardiogram changes.In the adjuvant chemotherapy group,6 patients(6.2%)had abnormal electrocardiogram changes.The difference was statistically significant.The trastuzumab group was monitored.There were 62 patients with LVEF,of which 8 patients had a decrease in LVEF,and the decrease was ≤5%.One patient had a decrease in left ventricular longitudinal compliance,and 2 patients had a left atrial enlargement with a history of hypertension.No patients developed congestive heart failure and sudden cardiac death.In the first-line treatment of the advanced stage,the ORR of the trastuzumab-treated group and the first-line group were 19.3% and 3.6%,respectively.The difference was not statistically significant.The DCR of the two groups was 58.1% and 14.3%,respectively.The median OS was 96 months and 86 months,respectively,The median OS was at 62 months and 6 months,and the differences were statistically significant.2.In the first-line treatment of the advanced stage,there was no statistically significant difference between the trastuzumab group and the anthracycline plus taxane,simple taxane,gemcitabine,and vinorelbine;3.Among the 32 patients receiving trastuzumab,29 patients(90.625%)had a single site metastasis,15 patients(51.72%)had non-visceral metastasis(lymph nodes,chest wall,bone),and 14(48.28%)patients had simple visceral(lung,liver)metastases.the ORR of the two groups were 33.3% and7.1%,respectively,and the DCR were 73.3% and 50%,respectively.The difference was not statistically significant.The median PFS of the two groups was 62 months and16 months,respectively.The median OS was 96 months and 55 months,respectively, and the difference was statistically significant.4.The interval between medication use and diagnosis ≤2 years compared with the group with > 2 years,The ORR of the two groups was 31.25% and 8.3%,respectively,and the DCR was 62.5%.50%,median PFS were 62 months,17 months,5-year survival rate: 85.7%,79.5%,the difference was not statistically significant.5.27 patients were monitored for ECG changes,and 5(18.5%)patients had abnormal ECG changes,4 of which were T-wave changes and 1was Q-T interval prolongation.There were 6 cases of LVEF decline,and no LVEF decreased by ≥15% was observed.No patients had cardiac structural disease during the monitoring process.No patients developed congestive heart failure and cardiac death.6.Among the 32 patients who received trastuzumab treatment,21(65.6%)had normal CA153 levels as baseline,and 11(34.4%)were higher.The ORR of the two groups was25% and 9.1%,respectively,and the DCR was 70% andb36.4%,difference was not statistically significant.The 5-year cumulative survival rates of the two groups were90% and 55.6%,respectively,P=0.05,and the statistical difference was significant.The median PFS was 62 months and 16 months,respectively,and the difference was statistically significant.Conclusion1.Trastuzumab combined with chemotherapy can prolong survival and improve the curative effect compared with chemotherapy alone in postoperative adjuvant therapy and advanced first-line therapy.2.There was no difference in the efficacy of trastuzumab combined with different chemotherapy regimens in the first-line treatment of Her-2 positive advanced breast cancer.3.Patients with CA153 within the normal range might have a longer survival time of Her-2 positive breast cancer using trastuzumab.4.In the adjuvant therapy,the combination of trastuzumab and chemotherapy was more likely to cause abnormal ECG changes than chemotherapy alone,but no significant cardiac damage and severe cardiotoxic events occurred in adjuvant therapy and first-line therapy.5.In the first-line treatment of trastuzumab,there was no significant difference in the objective response rate and disease control rate between the simple visceral metastasis and the non-visceral metastasis.The simple non-visceral metastasis group had a significant survival prolongation.6.There was no difference in efficacy between the group with the interval between medication and diagnosis ≤2 years and the group with the interval >2 years. |
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