A randomised cross-over trial comparing patient preference for oral capecitabine and 5-fluorouracil/leucovorin regimens in patients with advanced colorectal cancer.

BACKGROUND: Traditionally, metastatic colorectal cancer (MCRC) has been treated with intravenous (i.v.) 5-fluorouracil/leucovorin (5-FU/LV). The tumour-activated, oral fluoropyrimidine capecitabine demonstrates superior activity and favourable safety compared with the Mayo regimen, while potentially avoiding the complications and inconvenience associated with i.v. regimens. PATIENTS AND METHODS: Ninety-seven patients with previously untreated advanced/MCRC were randomised to receive capecitabine followed by i.v. 5-FU/LV [Mayo Clinic, in-patient de Gramont (IPdG) or out-patient modified de Gramont (OPdG) regimens], or i.v. 5-FU/LV followed by capecitabine.
RESULTS: Before treatment, of those patients for whom a preference was recorded, almost all (95%) preferred oral treatment (consistent across all treatment groups) and the majority retained this preference after treatment (64% overall; 86%, 63% and 50% in the Mayo, IPdG and OPdG groups, respectively). Following treatment, the principal reasons for oral treatment preference were increased convenience, home-based administration and tablet formulation. Treatment satisfaction was significantly higher with capecitabine compared with Mayo (P<0.05) and with OPdG compared with capecitabine (P<0.05). Quality of life (QoL) was largely constant across the regimens, although it appeared better with OPdG than capecitabine (P<0.05). Grade 3/4 adverse events were uncommon in all arms.
CONCLUSIONS: This study confirmed that the majority of patients with MCRC prefer oral to i.v. therapy, although the OPdG regimen appears to be the most popular i.v. option. Capecitabine clearly represents an effective, well-tolerated oral alternative to i.v. 5-FU/LV.

RCT Entities:   Population Interventions Outcomes