血管内皮抑素联合GP方案治疗转移性三阴性乳腺癌的临床研究

Clinical Study of the Combination of Endostar and GP Regimen in the Treatment of Metastatic TNBC

目的:对比重组人血管内皮抑素(YH-16)联合GP方案与GP方案在治疗转移性三阴性乳腺癌中的有效性和安全性。方法:55例转移性乳腺癌患者既往均经病理学诊断为三阴性浸润性导管癌,均接受过紫杉类及蒽环类药物治疗。随机分为观察组及对照组,其中观察组27例,给予重组人血管内皮抑素联合GP方案治疗(重组人血管内皮抑素15 mg静脉滴注d1～14,吉西他滨1 000mg/m^2静脉滴注d1,8;顺铂40mg/m^2静脉滴注d1,2);对照组28例,仅给予GP方案化疗,每3周为1个周期,每2个周期评价疗效。结果:55例患者均可评价疗效,观察组(27例):完全缓解(CR)3例(11.1%),部分缓解(PR)9例(33.3%),客观有效率(CR+PR)44.4%;对照组(28例):CR 1例(3.5%),PR 9例(32.1%),客观有效率(CR+PR)35.7%。两组中位疾病进展时间分别为7.0、5.2个月,无疾病进展生存比较有显著性差异(P=0.001)。不良反应主要为胃肠道反应及骨髓抑制,两组比较无显著性差异(P>0.05)。结论:重组人血管内皮抑素联合GP方案治疗转移性三阴性乳腺癌具有协同作用,未增加不良反应,可延长中位疾病进展时间,值得进一步研究。

Objective： This study aims to compare the efficacy and the toxicity of YH-16＋GP and GP regimens for metastatic tri- ple-negative breast cancer （TNBC）. Methods： Fifty-five metastatic TNBC patients with anthracycline and taxane resistance were ran- domly divided into two groups and received YH-16＋GP or GP treatment. The YH-16＋GP regimen was composed of YH-16 （15 mg dl, -14）, gemcitabine （1000 mg/m2 dl, 8）, and cisplatin （40 mg/mz dl, 2）, administered for 21 days per cycle. The GP regimen only includ- ed gemcitabine and cisplatin. The clinical responses of the patients were assessed after two cycles of chemotherapy. Results： In the YH-16＋GP group, 3 cases with complete response （CR） （11.1%） and 9 cases with partial response （PR） （33.3%） were identified. The to- tal response rate （CR＋PR） was 44.4%. In the GP group, 1 CR case （3.5%） and 9 PR cases （32.1%）, with total response rate （CR＋PR） of 35.7%, were recorded. The median time for the progression of the disease was 7.0 and 5.2 months, respectively, for the two groups. Sig- nificant differences in disease-free survival rate were found between the two groups （P=0.001）. Drug-related toxicity was denoted by gastrointestinal tract reaction and bone marrow depression, but no significant differences were found between the two groups （P〉0.05）. Conclusion： The YH-16＋GP regimen has better short-term efficacy, has acceptable toxicity, and improves the TTP regimen. Thus, the YH-16＋GP regimen can be considered a salvage regimen for metastatic TNBC.