GEMOX对比GX方案一线治疗晚期转移性胆系肿瘤的临床观察

Clinical Observation of GEMOX or GX as First Line Regimen for Advanced Billiary Tract Carcinoma

目的观察吉西他滨联合奥沙利铂方案(GEMOX组)或希罗达(GX组)方案一线治疗晚期转移性胆系肿瘤(BTCs)的有效性及安全性。方法回顾性分析经病理及影像学检查确诊为原发性胆系肿瘤Ⅳ期的61例患者。其中,GEMOX方案为一线治疗的31例,GX方案为一线治疗的30例。GEMOX组:吉西他滨1 000 mg/m2静脉滴注d1、8,奥沙利铂100 mg/m2静脉滴注d2。GX组:吉西他滨1 000 mg/m2静脉滴注d1、8;希罗达片1250 mg/m2,口服2次/日d1～14。两方案均21天为一周期。至少完成2周期化疗的患者进行疗效、不良反应评价,并分析生存情况。结果GEMOX组完全缓解(CR)2例、部分缓解(PR)6例、稳定(SD)15例,有效率(RR)为25.8%,疾病控制率(DCR)74.2%,中位疾病进展时间(mTTP)6.5月,中位总生存期(mOS)12月;GX方案组CR1例、PR5例、SD16例,RR20.0%,DCR73.3%,mTTP为6月,mOS为10月。两组的RR、DCR、mTTP、mOS差异均无统计学意义(P>0.05)。两组Ⅲ度白细胞减少分别为6.5%vs.6.7%,Ⅲ度血小板减少分别为6.5%vs.3.3%,两组比较差异无统计学意义(P>0.05)。而外周神经炎以GEMOX组显著,手足综合征仅见于GX组。结论GEMOX和GX方案均可作为一线治疗晚期转移性BTCs的推荐方案,两组不良反应均较轻,耐受性好,具体实施应根据患者个体耐受情况及药物毒性进行选择。

Objective To observe the efficacy and safety of Gemcitabine combined with Oxaliplatin（GE- MOX regimen） or Xeloda（GX regimen） as the first line regimen for patients with advanced biliary tract carcinoma（BTC）. Methods Sixty-one patients with primary biliary tract carcinoma were confirmed by pathologic and imaging examination as IVB stage. GEMOX （n = 31） was administrated as： gemcitabine 1 000 mg/m2 VD dl,8,oxaliplatin 100 mg/m2 VD d2; GX （n = 30） as： gemcitabine l 000 mg/m2 VD dl, 8, Xeloda tablets 1 250 mg/ m2 PO BID D1-14. Two egimens were repeated every 3 weeks. Response and toxicity were evaluated in patients who completed two cycles of chemotherapy at least. Results GE- MOX group achieved 2 complete remission（CR）, 6 partial remission （PR）, 15stable disease（SD） and 8 progressive disease（PD）and GX group achieved 1CR, 5PR, 16SD, and PD 8,. The overall response rate （RR） and disease control rate （DCR） in GEMOX group were 25. 8%and 74. 2% and in GX group 20. 0and 73. 3%, respetivly. The median disease progress time （mTTP） and the median overall sur- vival time （mOS） was 6. 5 months and 12 months in GEMOX group and in GX group 6 months and 10 months, respetivly. There were no significant difference between the two groups for RR, DCR, mTTP and mOS （P〈0. 05）. The most common toxicity in the GEMOX and GX regimens was myelosuppression, grade Ill leukopenia was 6. 5% and 6. 7% respectively, and gradeⅢ degree Thrombocytopenia was 6. 5% and 3. 3% respectively. Difference between two groups was not significant （P〈0. 05）. But pe ripheral neuritis had increased prevalence in the GEMOX group, and hand-foot syndrome was found only in the GX group, Conclusion GEMOX and GX regimens could both be recommended as the first-line treatments for patients with advanced biliary tract carcinoma. Adverse reactions of two groups were mild and well tolerated. How to specifically use should be based on individual tolerance and drug toxicity.