Oral capecitabine in combination with gemcitabine in management of advanced pancreatic carcinoma

ABSTRACT

Preclinical studies indicate positive biochemical and synergistic effects between capecitabine, an oral fluorouracil, and gemcitabine, the standard treatment for advanced pancreatic cancer [APC]. The goals of this study were to investigate the efficacy and safety of such combination for patients with APC. Twenty-two eligible patients with APC were treated with oral capecitabine and gemcitabine [CapGem regimen]. Capecitabine was given in a dose of 750 mg/m2 BID daily from day 1 to day 14 followed by one-week rest. Gemcitabine was given on day 1 and day 8 in a dose of 1000 mg/m2/dose given as i.v. infusion in 250 ml normal saline for 30 minutes of each 3-week cycle. Tumor lesions were assessed for objective response by physical examination and abdominal CT every two cycles of chemotherapy. Adverse events were monitored continuously during treatment and for one month after the last dose of the study. Estimation of survival was done every two months alter completion of chemotherapy cycles. The results revealed that among the 22 studied patients, two patients achieved complete clinical response [9.1%] and five patients [22.7%] achieved partial response with overall objective response rate 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 eight patients and dropped >90% in five patients. The median 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. In conclusion, capecitabine in combination with gemcitabine was well tolerated regimen with apparent efficacy in patients with APC. Therefore, the supra-additive antitumor effect of such combination regimen of CapGem plus the advantage of oral administration of capecitabine merits this protocol promising