Oral Capecitabine in Combination with Gemcitabine in Management of Advanced Pancreatic Carcinoma

Purpose: Preclinical studies indicate positive biochemical and synergistic effects between capecitabine, an oral fluorouracil and gemcitabine, the standard treatment for advanced pancreartic cancer (APC). The goals of this study were to investigate the efficacy and safety of such combination for patients with APC. Patients and Methods: Twenty-two eligible patients with APC were treated with oral capecitabine and gemcitabine (CapGem regimen). Capecitabine was given in a dose of 750mg/m² BID daily from day 1 to day 14 followed by 1-week rest. Gemcitabine was given on day 1 and day 8 in a dose of 1000mg/m²/dose given as IV infusion in 250ml normal saiine for 30 minutes of each 3-weeks cycle. Tumor lesions were assessed for objective response by physical examination and abdominal CT every 2 cycles of chemotherapy. Adverse events were monitored continuously during treatment and for 1 month after the last dose of study. Estimation of survival was done every 2 months after completion of chemotherapy cycles. Results: Among the 22 studied patients, 2 patients achieved complete clinical response (9.1 % ) and five patients (22. 7% of cases) achieved partial response with overall objective response rate was 31.8% (95% CI, 0.21 to 0.39). The median response duration of all responders was 31 weeks (95% CI, 18 to 39 weeks). CA 19-9 was dropped 50% in 8 patients (47.1%) and dropped 90% in 5 patients (29.4%). Themedian time to disease progression in all 22 patients was 32 weeks (95% CI, 21 to 40 weeks). The median survival for the whole studied group was 36 weeks (95% CI, 27 to 48 weeks). Treatment was generally well tolerated in the outpatient settings. Conclusion: Capecitabine in combination with gemcitabine was well-tolerated regimen with apparent efficacy in patients with APC. Therefore, the supra-additive anti tumor effect of such combination regimen of CapGem plus the advantage of oral administration of capecitabine merits this protocol promising. Further investigation for more studying of such combination is highly recommended.