NUTLEY, NJ -- April 19, 2000 -- Patients with
metastatic (advanced) colorectal cancer may benefit from the oral anti-cancer
agent Xeloda(R) (capecitabine), according to a new study published in the
Journal of Clinical
Oncology. Data from the study show that
treatment with Xeloda reduced tumor size beyond 50 percent in more than one of
five (24/108) patients in the study.
The Phase II, 48-week, randomized study was conducted at 21 cancer centers in eight countries including three centers in the United States. In September 1999, Hoffmann-La Roche Inc., maker of the drug, submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for approval of Xeloda's use in metastatic colorectal cancer. Xeloda is the first oral enzymatically-activated drug that works through therapeutic conversion to the cancer-fighting substance 5-FU. The sNDA is currently under review by the FDA and has not yet been approved. Xeloda is also being studied in different combination regimens in colorectal cancer.
"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, M.D., medical director of Oncology at Roche. Colorectal cancer is the fourth most common form of cancer, and the second leading cause of cancer deaths in the United States. About 50 to 60 percent of patients diagnosed with colorectal cancer eventually die of the disease.
The study followed 108 colorectal cancer patients whose cancer had spread beyond the colon or rectum. Patients were randomized to one of three treatment arms to receive capecitabine monotherapy (arms A and B) or as combination therapy in conjunction with 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 1-14) with a six-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 1-14) with a six-day rest period
The primary outcome measures for the study were tumor response and time to disease progression. Twenty-one percent of patients in arm A had tumors that had complete response or partial response compared to 24 percent in arm B and 23 percent in arm C. A complete response occurs when the tumor virtually disappears and a partial response is tumor shrinkage of more than 50 percent.
The median times to disease progression were 127 days in arm A, 230 days in arm B and 165 days in arm C of the study.
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 symptomatic treatment.
Patients who received capecitabine plus leucovorin had more acute toxicity (diarrhea, vomiting, abdominal pain, and hand-foot syndrome) than those receiving capecitabine alone.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics, vitamins, and fragrances and flavors. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: virology, including HIV/AIDS and hepatitis C; infectious diseases, including influenza; cardiology; neurology; oncology; transplantation; dermatology; and metabolic diseases including obesity and diabetes.