Capecitabine Demonstrates Favorable Response Rates in Advanced Colorectal Cancer Patients

Patients with metastatic colorectal cancer may benefit from therapy with the oral anticancer agent capecitabine (Xeloda), according to a study by investigators from Leuven, Belgium. Treatment with capecitabine reduced the size of tumors by more than 50% in 24 of 108 patients enrolled in the study. Capecitabine is the first oral enzymatically activated drug that works by conversion in the body to fluorouracil.

The phase II, 48-week, randomized trial was conducted at 21 cancer centers in eight countries, including three centers in the United States. The results were published in the March 2000 issue of the Journal of Clinical Oncology.

“The results of this study suggest that Xeloda may offer a new treatment option as an oral single agent in advanced colorectal cancer,” said Alain Thibault, MD, medical director of oncology at Hoffman-La Roche, Inc.

Three-Arm Design

The study followed 108 colorectal cancer patients whose cancer had spread beyond the colon or rectum. Patients were randomized to receive either capecitabine monotherapy (arms A and B) or capecitabine plus leucovorin (arm C).

Patients in arm A received continuous monotherapy with capecitabine (1,331 mg/m²/d). Patients in arm B received cyclical intermittent monotherapy with capecitabine (2,510 mg/m²/d, days 1 to 14) with a 6-day rest period. Patients in arm C received cyclical intermittent therapy with capecitabine (1,657 mg/m²/d) in combination with oral leucovorin (60 mg, days 1 to 14) with a 6-day rest period.

Of patients in arm A, 21% had tumors that showed a complete or partial response, compared to 24% in arm B and 23% in arm C. The median times to disease progression were 127 days in arm A, 230 days in arm B, and 165 days in arm C.

Acute Toxicity

Overall, diarrhea, nausea, and hand-foot syndrome were the predominant adverse events reported in all three treatment groups. These side effects were reversible and manageable with treatment interruption, dose reduction, and treatment of symptoms. Patients who received capecitabine plus leucovorin had more acute toxicity (diarrhea, vomiting, abdominal pain, and hand-foot syndrome) than those receiving capecitabine alone.

More information about the trial can be obtained by contacting Pamela Fears of Hoffmann-La Roche at 973-562-2209 or at her e-mail address, pamela.fears@roche.com.