The aim of this research was to study the pharmacokinetic characteristics of a slow-release 5-fluorouracil implant as well as to evaluate the clinical drug activity of this preparation in pancreatic cancer patients. Pharmacokinetic characteristics of the slow-release 5-fluorouracil implant were evaluated by examining the half-life time (T1/2) and apparent volume of distribution (Vd) in pancreatic cancer patients; the slow-release 5-fluorouracil implant was administered through interstitial chemotherapy (tumor interstitium implantation). In the drug activity study, 36 locally advanced unresectable pancreatic cancer patients were divided randomly into an experimental treatment group (n=18) and a standard treatment group (n=18). The experimental treatment group was treated with interstitial chemotherapy of a slow-release 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine; the standard treatment group was treated with systemic chemotherapy of gemcitabine. An internal drainage procedure was used when biliary and/or gastrointestinal tract obstruction occurred in the two groups. Clinical benefit response, including pain (visual analogue scale), analgesic drug use, general conditions (Karnofsky performance score), weight changes, and survival status, was observed. T1/2 of the slow-release 5-fluorouracil implant was 5475.8±136.4 min, whereas Vd was 45275.0±1028.6 l. Clinical benefit response in the experimental treatment group was better than that in the standard treatment group. The experimental treatment group had longer median survival time compared with the standard treatment group. The slow-release 5-fluorouracil implant could deliver drugs mainly in the regional area of the tumor and prolong the drug action time; interstitial chemotherapy of a 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine could improve the quality of life and survival status of pancreatic cancer patients. The method was promising and worthy of in-depth investigations.
The aim was to develop a slow-release poly-lactic-coglycolic acid (PLGA)-oxaliplatin microsphere and to assess the therapeutic effectiveness and safety of this preparation on colorectal tumor in vivo. The PLGA-oxaliplatin microsphere was prepared based on a spray-drying method, and the drug loading and in-vitro oxaliplatin release profile were carried out using high performance liquid chromatography. The inhibiting effect on tumor growth was examined using in-vivo subcutaneously inoculated colorectal tumor models of nude mice. The size of the microsphere was less than 100 microm, drug loading was 18-22% and drug release time lasted as long as 30 days. PLGA-oxaliplatin microspheres significantly restrained tumor growth and this effect correlated with decreased expression of proliferating cell nuclear antigen and increased expression of terminal deoxynucleotidyltransferase dUTP nick end labeling in tumor cells. Bodyweight measurement and blood analysis did not suggest significant adverse effects on the mice during the study. The PLGA-oxaliplatin microsphere developed here was suitable for regional use; it appears safe and effective in controlling the tumor growth. This preparation shows promise in reducing local recurrence of colorectal cancer after resection, but needs further investigation.
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