Random and control study comparing gemcitabine administered in fixed dose rate with a more standard infusion combined with oxaliplatin regimens in advanced biliary tract cancer patients / 中国肿瘤临床

ABSTRACT

Objective:To investigate and compare the effects of oxaliplatin combined with gemcitabine administered in a fixed dose rate and that administered in a more standard infusion in advanced biliary tract cancer patients on chemotherapeutic efficacy, toxicities, and survival time. Methods:A total of 93 cancer patients were recruited from February 1, 2010 to December 12, 2012 in the First Hospital of Huai'an City Affiliated Nanjing Medical College. Those recruited were either newly diagnosed unresectable advanced biliary tract cancer patients by percutaneous liver biopsy or relapse or metastatic biliary tract cancer patients after operation. The patients were randomly divided into two groups. The first group was the study group in which the patients received chemotherapy with gemcitabine in a fixed dose rate of 10 mg/m2 per minute combined with oxaliplatin regimens. The other group was the control group in which the patients received chemotherapy with gemcitabine in a more standardized infusion within 30 min combined with oxaliplatin regimens. Each patient received four cycles, with at least two cycles of chemotherapy with GEMOX regimens every 21 d, with follow-up until death. The chemotherapeutic efficacy was evaluated. Toxicities were documented after each cycle. Results:The clinical characteristics of the two groups were well balanced before chemotherapy (P>0.05). The response rate (RR) and clinical benefit response of the study group were higher than those of the control group (P0.05). Conclusion:Gemcitabine in a fixed dose rate combined with oxaliplatin regimens is a feasible and effective scheme in treating advanced biliary tract cancer patients. RR is higher and OS and TTP are longer under this scheme. Non-hematological toxicities are also well tolerated. However, hematological toxicity is distinguished. These results guide us to be prudent in utilizing this regimen. The investigation of the value of gemcitabine in a fixed dose rate combined with oxaliplatin in treating advanced biliary tract cancer patients is worth pursuing in future clinical trials.