DGNews
Patients With Metastatic Colorectal Cancer May Benefit From Xeloda
(Capecitabine)
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.
