Sodium Danshensu the end of the treatment.An analysis on survival, toxicity and QoL analysis was done in a modified intent to treat (ITT) population. The modified ITT population was defined as all randomly assigned patients who received chemotherapy at least once. The ORR was evaluated in the modified ITT population with measurable lesion. Survival curves were generated using the Kaplan– Meier method and compared by the log-rank test. An analysis of the QLQ-C30 questionnaires was done in accordance with the EORTC guidelines.21 The linear mixed model was used to compare each scale of the QoL by the cycle and treatment arms.
Kaplan–Meier methodology was used to measure times to 10% deterioration in QoL scores. Data analysis was done with SPSS software. Biliary tract cancers (BTC) are relatively rare tumors with a dismal prognosis. This kind of tumor is more likely to occur in patients aged between 50 and 70 years. As far as the role of nonsurgical oncologic treatment is concerned, the only standard regimen for advanced disease has recently been Ridaforolimus established. In fact, the ABC-02 study, a practice-changing phase III study, recognized the gemcitabine/cisplatin regimen as the standard of care, with a stable disease rate of 81%, progression-free survival (PFS) of 8 months and median overall survival (OS) of 11.7 months. Due to clinical conditions, patients who receive palliative chemotherapy are usually treated with single-agent gemcitabine or with combination demographic regimens including mitomycin or fluoropyrimidines. Response rates with these treatments range from 10 to 35%, and median OS time varies between 5 and 12 months.
Nevertheless, the small number of published trials and the considerable variability in the patients’ clinical characteristics make the data difficult to interpret. Nowadays, there is no standard chemotherapy regimen in BTC. Several reports have demonstrated that gemcitabine is active in purchase Rutin BTC. Capecitabine (Xeloda TM ; Hoffmann-La Roche, Basel, Switzerland) is an oral fluoropyrimidine carbamate that selectively generates 5-FU in tumor tissues. Gemcitabine also appears to modulate the activity of 5-fluorouracil (5-FU) in renal and gastrointestinal malignancies. Capecitabine offers the possibility of continuous tumor exposure to 5-FU by preferential activation at the tumor, while potentially minimizing the exposure of healthy body tissues to systemic 5-FU.
Moreover, 5-FU has demonstrated activity in BTC. As shown in our phase I study, to enhance the cytotoxic activity of gemcitabine, an alternative infusion regimen has been explored. As the active metabolite of gemcitabine, difluorodeoxycytidine triphosphate (dFdCTP), has a long order Indole-3-carbinol intracellular half-life, a fixed-dose rate (FDR) infusion of 10 mg/m 2 /min has been shown to lead to maximal intracellular accumulation. In particular, it has been demonstrated that increasing the infusion time while holding the dose rate constant at 10 mg/ m 2 /min could result in increased intracellular levels of dFdCTP, thus enhancing the activity of gemcitabine. On the basis of phase I results, the dose of FDR gemcitabine 800 mg/m 2 in 80 min on days 1 and 8 plus capecitabine 650 mg/m.