An international team compared the efficacy and safety of orally administered capecitabine (Xeloda) with that of intravenous (IV) 5-FU plus leucovorin (5-FU/LV), as first-line treatment for metastatic colorectal cancer.
Capecitabine is a novel fluoropyrimidine carbamate designed to mimic continuous fluorouracil (5-FU) infusion, but with preferential activation at the tumor site.
Some 602 patients were enrolled in the study, and were prospectively randomized to one of two treatment regimens.
The first was capecitabine 1,250 mg/m2 administered twice daily, on days 1 to 14, every 3 weeks.
The second treatment option was the 4-weekly Mayo Clinic regimen (5-FU/LV), administered until disease progression or unacceptable toxicity.
The overall response rate was 19% for capecitabine and 15% for 5-FU/LV.
Median time to disease progression was 5.2 and 4.7 months in the capecitabine and 5-FU/LV groups, respectively.
| Capecitabine may have greater efficacy and be safer than 5-FU/LV.
| Journal of Clinical of Oncology |
The median time to treatment failure was 4.2 and 4.0 months; and median overall survival was 13.2 and 12.1 months.
The researchers found that the toxicity profiles of both treatments were typical of fluoropyrimidines. However, capecitabine led to significantly lower incidences of stomatitis and alopecia, but a higher incidence of cutaneous hand-foot syndrome.
Capecitabine also resulted in lower incidences of grade 3/4 stomatitis and neutropenia, leading to a lower incidence of grade 3/4 neutropenic fever and sepsis.
Only grade 3 hand-foot syndrome and uncomplicated grade 3/4 hyperbilirubinemia were reported more frequently with capecitabine.
Eric Van Cutsem, of University Hospital Gasthuisberg, Leuven, Belgium, concluded on behalf of fellow authors, "Oral capecitabine achieved an at least equivalent efficacy compared with IV 5-FU/LV.
"Capecitabine demonstrated clinically meaningful safety advantages and the convenience of an oral agent."