伊尼妥单抗联合吡咯替尼（中国双靶）多线治疗晚期Her2阳性乳腺癌的临床疗效观察

Clinical efficacy observation of multi-line therapy of inetetamab combined with pyrotinib (China double target) in patients with Her2 positive breast cancer

摘要:

目的： 探讨伊尼妥单抗联合吡咯替尼治疗三线或以上晚期Her2阳性乳腺癌患者的疗效及安全性。方法： 收集10例多线治疗失败后，采用伊尼妥单抗联合吡咯替尼治疗为基础用药的晚期Her2阳性乳腺癌患者临床资料，分析患者的近期疗效、不良反应及生存情况。结果： 随访至2021年4月1日，客观缓解率为90%（9/10），中位无进展生存期为5.87个月。10例晚期Her2阳性乳腺癌患者疗效为：CR 0例；PR 9例，其中1例PR患者因经济原因停药，病情仍稳定，另1例PR患者无进展生存期为5个月，后因肺部进展、胸水、肺不张抢救无效死亡，1例PR患者完成9个疗程后，因“肺部转移进展”换药，目前病情仍在评价中，其余6例患者仍在随访中；SD患者1例，是晚期五线治疗患者，SD患者无进展生存期为1.5个月，后因肺部转移进展抢救无效死亡。治疗期间患者主要的不良反应为乏力、胃胀和腹泻，其中70%（7/10）的患者发生2~3级乏力、胃胀，90%（9/10）的患者发生1~2级腹泻，大部分患者联合化疗方案发生轻度骨髓抑制。结论： 伊尼妥单抗联合吡咯替尼（中国双靶）为基础的方案用于多线治疗失败后的晚期Her2阳性乳腺癌具有较好的近期疗效，安全性较高，值得进一步大样本随访观察对比研究。

Abstract:

Objective: To explore the efficacy and safety of the third-line or above therapy of inetetamab combined with pyrotinib in patients with advanced Her2 positive breast cancer. Methods: Clinical data of 10 patients with advanced Her2 positive breast cancer treated with inetetamab combined with pyrotinib after the failure of multiline therapy were collected to analyze the short-term efficacy, adverse reactions, and the survival. Results: The follow-up went until April 1, 2021. The objective response rate was 90% (9/10) , and the median progression-free survival time was 5.87 months. The efficacy of 10 patients with advanced Her2 positive breast cancer was as follows: 0 case of CR; 9 cases of PR, of which 1 PR patient suffered interruption for economic reasons and was remained stable. The progression-free survival time of the other PR patient was 5 months, and then the patient died of the progress of pulmonary metastasis, pleural effusion, and atelectasis, despite emergency rescue efforts. After 9 courses of treatment, 1 PR patient changed the therapy due to "the progression of pulmonary metastasis" , and the condition was still under evaluation. The remaining 6 patients were still in follow-up. One SD patient was treated with advanced fifth-line therapy, and the progression-free survival of the SD patient was 1.5 months. The SD patient died of the progression of pulmonary metastasis, despite emergency rescue efforts. The main adverse reactions during treatment were fatigue, stomach distension, and diarrhea. Of these, 70% (7/10) of patients had grade 2-3 fatigue and stomach distention, and 90% (9/10) of patients had grade 1-2 diarrhea. Most patients had mild bone marrow suppression in the combination with chemotherapy. Conclusion: The treatment regimen of inetetamab combined with pyrotinib (China double target) in patients with advanced Her2 positive breast cancer after the failure of multi-line therapy has significant short-term efficacy and good safety, which is worthy of further large sample follow-up observation and comparative study.