马来酸吡咯替尼治疗曲妥珠耐药HER-2阳性晚期乳腺癌的临床观察

目的观察马来酸吡咯替尼治疗曲妥珠耐药的人表皮生长因子受体2(human epidermal growth factor receptor 2, HER-2) HER-2阳性晚期复发转移性乳腺癌的疗效和不良反应。方法回顾性分析口服马来酸吡咯替尼为基础治疗病人88例，分析其客观有效率、疾病控制率、临床获益率、中位无进展生存时间(progress free survival，PFS)、预后因素及不良反应。结果88例病人可评价近期疗效，1例完全缓解，33例部分缓解，34例病情稳定，20例病情进展；客观有效率38.6%，疾病控制率77.3%，临床获益率64.8%，中位PFS 11.335个月。采用秩和检验分析ECOG评分与近期疗效有关(P < 0.05)，采用Log-rank单因素分析，ECOG评分和曲妥珠耐药情况对PFS有影响。不良反应为腹泻、恶心呕吐、乏力、手足综合征、口腔溃疡症状。结论以口服吡咯替尼为基础的方案可以有效应用于曲妥珠耐药的晚期复发转移性HER-2阳性乳腺癌病人，总体不良反应可以耐受。

Clinical observation of pyrrotinib maleate in the treatment of trastuzumab-resistant HER-2 positive advanced breast cancer

ObjectiveTo investigate the efficacy and adverse reaction of pyrrotinib maleate in the treatment of trastuzumab-resistant human epidermal growth factor receptor 2(HER-2) positive advanced breast cancer.MethodsThe clinical data of 88 patients treated with pyrrotinib maleate were retrospectively analyzed.The objective response rate(ORR), disease control rate(DCR) clinical benefit rate(CBR), progress free survival(PFS), prognostic factor and adverse reaction in all cases were analyzed.ResultsThe analysis results of short-term efficacy of patients showed that 1 case of complete response, 33 cases of partial response, 34 cases of stable disease and 20 cases of progression disease were identified, and the ORR, DCR, CBR and median PFS were 38.6%, 77.3%, 64.8% and 11.335 months, respectively.The results of rank sum test showed that the ECOG score was correlated with the short-term efficacy(P < 0.05).The Log-rank univariate analysis showed that the ECOG score and trastuzumab resistance affected the PFS.The adverse reactions included the diarrhea, nausea and vomiting, fatigue, hand-foot syndrome and oral ulcer symptoms.ConclusionsThe oral pyrroitini-based regimens can be effectively used in trastuzumab resistant patients with advanced, relapsing and metastatic HER-2 positive breast cancer, and the adverse reactions can be tolerated.