Capecitabine (Xeloda (TM)) improves medical resource use compared with 5-fluorouracil plus leucovorin in a phase III trial conducted in patients withadvanced colorectal carcinoma

Standard therapy for advanced or metastatic colorectal cancer consists of 5 -fluorouracil plus leucovorin (5-FU/LV) administered intravenously (i.v.). Capecitabine (Xeloda(R)), an oral fluoropyrimidine carbamate which is prefe rentially activated by thymidine phosphorylase in tumour cells, mimics cont inuous 5-FU and is a recently developed alternative to i.v. 5-FU/LV. The ch oice of oral rather than intravenous treatment may affect medical resource use because the two regimens do not require the same intensity of medical i ntervention for drug administration. and have different toxicity profiles. Here we examine medical resource use in the first-line treatment of colorec tal cancer patients with capecitabine compared with those receiving the May o Clinic regimen of 5-FU/LV. In a prospective, randomised phase III clinica l trial. 602 patients with advanced or metastatic colorectal cancer recruit ed from 59 centres worldwide were randomised to treatment with either capec itabine or the Mayo regimen of 5-FU/LV. in addition to clinical efficacy an d safety endpoints, data were collected on hospital visits required For dru g administration. hospital admissions, and drugs and unscheduled consultati ons with physicians required for the treatment of adverse events. Capecitab ine treatment in comparison to 5-FU/LV in advanced colorectal carcinoma res ulted in superior response rates (26.6% versus 17.9%, P = 0.013) and improv ed safety including less stomatitis and myelosuppression. Capecitabine pati ents required substantially fewer hospital visits for drug administration t han 5-FU/LV patients. Medical resource use analysis showed that patients tr eated with capecitabine spent fewer days in hospital for the management of treatment related adverse events than did patients treated with 5-FU/LV. In addition, capecitabine reduced the requirement for expensive drugs. in par ticular antimicrobials fluconazole and 5-HT3-antagonists to manage adverse events. As anticipated with an oral home-based therapy patients receiving c apecitabine needed more frequent unscheduled home, day care, office and tel ephone consultations with physicians. In the light of clinical results from the phase III trial demonstrating increased efficacy in terms of response rate, equivalent time to progression (TTP) and survival (OS), and a superio r safety profile, the results From this medical resource assessment indicat e that capecitabine treatment of colorectal cancer patients results in a su bstantial resource use saving relative to the Mayo Clinic regimen of 5-FU/L V. This benefit is derived principally from the avoidance of hospital visit s for i.v. drug administration. less expensive drug therapy for the treatme nt of toxic side-effects, and fewer treatment-related hospitalisations requ ired during the course of therapy for adverse drug reactions in comparison to patients treated with 5-FU/LV. (C) 2001 Elsevier Science Ltd. All rights reserved.