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目的观察吉西他滨(GEM)为主方案联合重组人血管内皮抑素(恩度)治疗晚期胆系肿瘤(biliary tract cancer,BTC)的疗效及安全性,探讨恩度在BTC治疗中的作用。方法选取2005-01-01-2015-04-01解放军第八一医院全军肿瘤中心收治的ⅣB期BTC患者109例为研究对象,分为恩度联合组(n=25)和单纯化疗组(n=84)。恩度联合组:吉西他滨和顺铂(GP,n=1)或奥沙利铂(GEMOX,n=22)或卡培他滨(GX,n=2)联合恩度。吉西他滨1 000mg/m2,静脉滴入,d1、d8;顺铂20mg,d2~d6。或者奥沙利铂100 mg/m2,静脉滴入,d2。或者卡培他滨1 000 mg/m2,口服,2次/d,d1~d14。恩度15mg,静脉滴入,d1~d14,3周为1个周期。单纯化疗组:仅给予GP(n=9)或GEMOX(n=40)或GX(n=35)方案化疗,剂量与使用方法同联合组。2个周期后按照RECIST 1.0标准、NCI-CTC 3.0版分别评价疗效与不良反应。用Kaplan-Meier法绘制生存曲线,Log-Rank检验进行两组比较。结果恩度联合组25例患者,CR 1例,PR 8例,SD12例,PD 4例,有效率(resonse rate,RR)36.0%,疾病控制率(disease control rate,DCR)84.0%;中位无进展生存时间(progression-free survival,PFS)为5.8个月,中位总生存时间(overall survival,OS)为12.3个月;生活质量(quality of life,QOL)改善及稳定率为88%。单纯化疗组84例患者,CR 1例,PR 10例,SD 42例,PD 31例,RR为13.1%,DCR为63.1%;中位PFS为3.8个月,中位OS为8.0个月;QOL改善及稳定率80.9%。两组RR和DCR比较差异有统计学意义,P<0.05;两组中位PFS和中位OS比较差异有统计学意义,P<0.05。两组不良反应最常见为骨髓抑制,其他不良反应包括恶心、呕吐、外周神经炎、皮疹、发热和手足综合征等,以1~2级为主,两组比较差异无统计学意义,P>0.05。化疗联合恩度组仅2例出现心电图T波改变,1例出现房性早搏,3例出现轻度血压升高。结论吉西他滨为主方案联合恩度治疗晚期BTC近期有效率和疾病控制率高于单纯化疗组,延长疾病至肿瘤进展时间和总生存时间,总体耐受性良好,值得临床进一步观察。
Objective To investigate the efficacy and safety of gemcitabine (GEM) combined with recombinant human endostatin in the treatment of advanced biliary tract cancer (BTC) and to explore the role of Endostar in the treatment of BTC. Methods A total of 109 stage ⅣB BTC patients were enrolled in the Tumor Center of the PLA from January 2005 to January 2015 in the First Hospital of PLA. The subjects were enrolled in the enamel combination group (n = 25) and the chemotherapy alone group (n = n = 84). Endostar group: gemcitabine combined with cisplatin (GP, n = 1) or oxaliplatin (GEMOX, n = 22) or capecitabine (GX, n = 2) Gemcitabine 1 000mg / m2, intravenous infusion, d1, d8; cisplatin 20mg, d2 ~ d6. Or oxaliplatin 100 mg / m2, intravenous infusion, d2. Or capecitabine 1 000 mg / m2, orally, 2 times / d, d1 ~ d14. Endurance 15mg, intravenous infusion, d1 ~ d14, 3 weeks for a cycle. Chemotherapy alone group: given only GP (n = 9) or GEMOX (n = 40) or GX (n = 35) regimen chemotherapy, dose and use of the same combination group. After 2 cycles according to the RECIST 1.0 standard, NCI-CTC version 3.0 were evaluated efficacy and adverse reactions. Survival curves were drawn by Kaplan-Meier method, and Log-Rank test was used to compare two groups. Results There were 25 CR patients, CR 8 cases, SD 12 cases and PD 4 cases, with 36.3% RR and 84.0% disease control rate (DCR). The median The progression-free survival (PFS) was 5.8 months. The median overall survival (OS) was 12.3 months. The QOL improvement and stability rate was 88%. Among the 84 patients in the chemotherapy alone group, CR 1, PR 10, SD 42, and PD 31 had RR of 13.1% and DCR of 63.1%. The median PFS was 3.8 months and the median OS was 8.0 months. QOL Improvement and stability rate 80.9%. There was significant difference between the two groups in RR and DCR (P <0.05). There was significant difference between the two groups in median PFS and median OS, P <0.05. Two groups of adverse reactions most commonly bone marrow suppression, other adverse reactions, including nausea, vomiting, peripheral neuritis, rash, fever and hand-foot syndrome, etc., mainly in 1 to 2, no significant difference between the two groups, P> 0.05. In the chemotherapy combined enamel group, only 2 patients showed T wave changes, 1 patient had atrial premature beats, and 3 patients had mild hypertension. Conclusions Gemcitabine-based regimen combined with Endue treatment of advanced stage BTC has higher effective rate and disease control rate than that of chemotherapy alone. It prolongs the progression of disease to the time of tumor progression and overall survival. The overall tolerability is good, and it is worth further clinical observation.