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目的：比较人表皮生长因子受体2 过表达（HER2+）的患者既往接受以曲妥珠单抗为基础辅助或新辅助治疗后再次接受针曲妥珠单抗治疗的临床结果。方法：共247 例（I-III期170 例，IV 期77 例）HER2+转移性乳腺癌患者，其中首次接受曲妥珠单抗治疗患者211 例（I-III 期134 例，IV 期77 例），再次接受曲妥珠单抗治疗患者36 例（I-III 期）。使用Cox 比例风险回归和logistic 回归分析首次或提前接受曲妥珠单抗治疗的患者的预后的临床结果，生存评估使用Kaplan-Meier 法。结果：I-III 期HER2+转移性乳腺癌患者中，未预先接受曲妥珠单抗治疗组的中位总生存期为36 个月和预先接受曲妥珠单抗治疗组为28 个月（危害比[HR]， 1.45; 95%CI, 1.05-2.02[P=0.012]）；I-IV 期HER2+转移性乳腺癌患者中，未预先使用曲妥珠单抗组的中位总生存期为37个月，客观缓解率58 %；临床获益率77%；预先使用曲妥珠单抗组为25 个月，客观缓解率28%；临床获益率37 %；调整后的比值比为客观缓解率0.37（9%CI，0.18-0.77; P=0.010）和临床获益率0.28（95%CI，0.14-0.59; P =0.014）。单因素分析没有提前接受曲妥珠单抗治疗组中位总生存率较长（P=0.012）。多因素分析发现总生存率没有显著差异（P=0.19）。结论：当曲妥珠单抗用于转移性疾病，没有提前接受曲妥珠单抗治疗的HER2+乳腺癌患者临床结果优于提前接受曲妥珠单抗治疗的患者。

英文摘要:

Objective:The aim of this study was to compare the outcomes of patients with human epidermal growth factor receptor 2 (HER2)overexpressed(HER2+) breast cancer that were treated or not treated with trastuzumab previously for metastatic breast cancer.Methods:A total of 247 patients (170 I-III stage, 77 IV stage) with metastatic HER2+ breast cancer were selected for this study. There were 211 patients ((134, I-III stage; 77, IV stage) who received trastuzumab treatment for the first time and 36 patients who received trastuzumab treatment previously. The clinical outcomes of patients who had or not received prior trastuzumab were compared using Cox proportional hazards regression and logistic regression analyses. The survival was assessed using the Kaplan-Meier method.Results:The median overall survival of HER2+ metastatic breast cancer (I-III stage) was 36 months in the group who did not receive prior trastuzumab and 28 months in the group previously treated with trastuzumab ( [HR], 1.45; 95% CI, 1.05-2.02 [P=0.012]). The median overall survival of HER2+ metastatic breast cancer (I-IV stage) was 37 months, objective response rate was 58%, clinical benefit rates was 76% in the group who did not receive prior trastuzumab and 25 months, 28 %, 37 % in the group previously treated with trastuzumab, respectively. The adjusted odds ratios were 0.37 (P=0.010) for objective response rates and 0.38 (P=0.014) for clinical benefit rates. In the univariate analysis, the median overall survival rate was longer in the group who did not receive prior trastuzumab (P=0.012). The multivariate analysis found no significant difference in overall survival (P=0.19).Conclusion:The HER21 metastatic breast cancer patients that had not received treatment of trastuzumab had superior clinical outcomes than those with prior exposure.

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