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

Objective To observe the efficacy and safety of Gemcitabine combined with Oxaliplatin（GEMOX 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 d1，8，oxaliplatin 100 mg/m² VD d2; GX (n=30) as: gemcitabine  000 mg/m² VD d1，8，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 GEMOX 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 20.0% and 73.3%, respetivly. The median disease progress time (mTTP) and the median overall survival 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 Ⅲ leukopenia was 6.5% and 6.7% respectively, and grade Ⅲ degree Thrombocytopenia was 6.5% and 3.3% respectively. Difference between two groups was not significant (P>0.05). But peripheral 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.