摘要
目的评估曲妥珠单抗(trastuzumab,H)与紫杉醇脂质体(paclitaxel liposome,P)、卡培他滨(capecitabine,X)的联合方案HPX方案治疗人表皮生长因子受体-2(human epidermal growth factor receptor-2,HER-2)阳性复发转移性乳腺癌的疗效与安全性。方法筛选HER-2阳性复发转移性乳腺癌患者32例,给予HPX方案治疗:曲妥珠单抗首次8 mg/kg,后6 mg/kg维持,d1;紫杉醇脂质体175 mg/m2,d1;卡培他滨825 mg/m2,2次/d,d1-14,21天为1周期。结果 32例患者中位无进展生存时间(progression-free survival,PFS)为12.7月(95%CI:5.7-19.7月),客观缓解率(objective response rate,ORR)为53.2%,临床获益率(clinical benefit rate,CBR)为84.5%。一线治疗患者的PFS达15.3月(95%CI:2.5-28.1月),ORR达68.4%,CBR达84.2%。Ⅲ~Ⅳ级不良反应主要为血液学毒性,包括中性粒细胞减少(46.9%)、白细胞减少(37.5%)、血小板减少(6.3%),Ⅲ~Ⅳ级非血液学不良反应主要为手足综合征(9.4%)和腹泻(3.1%)。结论曲妥珠单抗联合紫杉醇脂质体和卡培他滨是治疗HER-2阳性复发转移性乳腺癌的有效治疗方案,且安全性良好。
Objective To evaluate the efficacy and safety of trastuzumab( H) plus paclitaxel liposome( P) and capecitabine( X) as salvage therapy HPX for human epidermal growth factor receptor-2( HER-2) positive metastatic breast cancer patients. Methods Thirty-two cases of HER-2 positive locally advanced or metastatic breast cancer were enrolled in this study. The patients were given HPX therapy with trastuzumab 8 mg / kg loading dose followed by 6 mg / kg dose on day1,paclitaxel liposome 175 mg / m2 on day 1,and capecitabine 825 mg / m2 twice daily on days 1- 14 for every 3 weeks as a cycle. Results Among the 32 patients,the median progression-free survival( PFS) time was 12. 7 months( 95% CI:5. 7- 19. 7 months),the regimen achieved objective response rate( ORR) was 53. 2%,and the clinical benefit rate( CBR) was 84. 5%. Notably,for patients receiving combined regimen as their first line therapy,the median PFS reached15. 3 months( 95% CI: 2. 5- 28. 1 months),along with an ORR of 68. 4% and a CBR of 84. 2%. The most common grade Ⅲ / Ⅳ adverse event was hematological toxicity,such as neutropenia( 46. 9%),leucopenia( 37. 5%) and thrombocytopenia( 6. 3%). Hand-foot syndrome( 9. 4%) and diarrhea( 3. 1%) were the most common non-hematological gradeⅢ /Ⅳ adverse events. Conclusion Combination of trastuzumab and paclitaxel liposome plus capecitabine is an effective and well-tolerated regimen in treating patients with HER-2 positive metastatic breast cancer.
作者
黄香
吴昊
李薇
殷咏梅
Huang Xiang Wu Hao Li Wei et al(Department of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China)
出处
《实用肿瘤杂志》
CAS
2016年第6期550-554,共5页
Journal of Practical Oncology