Observation of GEMOX regimen combined with endostar as the first-line treatment for patients with ad-vanced biliary tract carcinoma

LI Rong; QIN Shukui; LIU Xiufeng; GONG Xinlei; HUA Haiqing; WANG Lin; CHEN Yingxia

Abstract：Objective To observe the efficacy and safety of endostar combined with gemcitabine and oxaliplatin as the first-line treatment for patients with advanced biliary tract carcinoma. Methods Forty-eight patients from Jan. 2009 to Aug. 2013 confirmed with pathologic and imaging examination as stage ⅣB primary biliary tract carcinoma were reviewed. Twenty cases received endostar+GEMOX regimen and 28 cases were applied with GEMOX regimen alone. GEMOX regimen was given as follow:gemcitabine 1000mg/m2 iv, d1 ,d8;oxaliplatin 100mg/m2 iv, d2 , 21 days was a cycle. Endostar was given 15mg iv d1-d14 , 21 days was a cycle. The effica-cy was evaluated strictly after 2 cycles according to RECIST 1?1 criteria, quality of life(QoL)was evaluated accoding to karnofsky scores,safety was evaluated after 1 cycle according to NCI CTC 3?0 version criteria. The time to progress(TTP)and overall survival ( OS) were also observed. Results In GEMOX+endostar group, 1 was in CR,3 in PR,12 in SD, and 4 in PD; the response rate (RR)was 20?0%, disease control rate(DCR)was 80?0%; median TTP was 8?6 months and the median OS was 14?0 months; the QoL improved and stable rate was 80?0%. In GEMOX group, 1 was in CR,5 in PR,15 in SD, and 7 in PD; RR was 21?5%, and DCR was 75?0%; the median TTP was 6?0 months and the median OS was 10?0 months; the QoL improved and stable rate was 71?4%. There was statistical difference in TTP and OS between the two groups( P<0?05) . The most common toxicity in the two groups were myelosuppression, other main toxicities included nause/vommiting, liver dysfaction, peripheral nearitis, skin allergy reaction and etc, mainly in grade 1-2, and there were no sugnificant differences between the two groups( P>0?05) . In GEMOX+endostar group, on- ly 2 case of non-specific T wave changed. One case was of auricular flutter, and 1 case with mild hypertension. Conclusion GEMOX+endostar as the first-line treatment for advanced BTCs has good efficacy, may improve or stabilize the patient?s QoL and prolong surviv-al, and the toxicities are well-tolerated, which worth clinical use and further observation.