Objective: The aim of the study was to observe the cardiac toxicity caused by different doses of epirubicin in the adjuvant treatment of breast cancer and to evaluate the long-term efficacy. Methods: The 180 cases of breast cancer patients received epirubicin based adjuvant chemotherapy. The patients were randomly assigned to high-dosage group(90 mg/m2), medium-dosage group(70 mg/m2) and low-dosage group(50 mg/m2), the primary endpoint was cardiac toxicity. The secondary outcomes were the 5-year overall survival(OS) and 5-year disease-free survival(DFS). Results: During chemotherapy, the clinical symptoms such as palpitation, dyspnea and paroxysmal nocturnal dyspnea occurred in 6 patients with the high-dosage group, 4 patients with the medium-dosage group and 3 patients with the low-dosage group. The number of patients who had changed in electrocardiogram(ECG) was 7, 5 and 4 in three groups, respectively. The echocardiographic showed each group had only one case with LVEF 0.05). In the three groups, the 5-year DFS rates were 73.3%(44/60) in high-dose group, 53.3%(32/60) in medium-dose group and 41.6%(25/60) in low dose group. The 5-year OS rates were 85.0%(51/60), 68.3%(41/60) and 58.3%(35/60) in three groups, respectively. The differences were statistically significant(P < 0.05). Conclusion: The high-dose epirubicin in adjuvant chemotherapy with CEF(cyclophosphamide, epirubicin and fluorouracil) regimen could improve the 5-year OS rate and 5-year DFS rate on patients of breast cancer. The cardiotoxicity was mild-moderate and well tolerated.
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机译:曲妥珠单抗在辅助和新辅助乳腺癌中的心脏毒性分析。 IV期药物警戒研究由“ Observatoire desMédicamentset InnovationsThérapeutiques”(OMIT B PL)领导[IV期药物警戒研究涉及曲妥珠单抗作为乳腺癌的新辅助剂和佐剂的心脏毒性。布列塔尼和卢瓦尔河沿岸药物与治疗创新观察所进行的分析(OMIT B PL)]