The Journal of Clinical Oncology Publishes Phase III Clinical Study Using Oral Chemotherapy Xeloda(R) (Capecitabine) for Metastatic Colorectal Cancer

Apr 12, 2001, 01:00 ET from Hoffman-La Roche Inc.

    NUTLEY, N.J., April 12 /PRNewswire/ -- The April 15 edition of the Journal
 of Clinical Oncology features Phase III clinical data about the use of Roche's
 Xeloda(R) (capaceitabine), an oral chemotherapy, in the first-line treatment
 of metastatic colorectal cancer, the second leading cause of cancer mortality
 among Americans.  The U.S. Food and Drug Administration is currently reviewing
 Xeloda as an oral chemotherapy for the treatment of colorectal cancer.
     The randomized Phase III clinical study published in JCO is one of the two
 phase III studies supporting the new indication for Xeloda.  This published
 study involved 605 patients with metastatic colorectal cancer.  Half the
 patients received repeated cycles of twice-daily oral doses of Xeloda at 1250
 mg/m2 given for two weeks, followed by a one-week rest period.  The other half
 of the patient group received treatment with intravenous 5-FU, 425 mg/m2 and
 leucovorin 20mg/m2 (the Mayo Regimen and a standard of care) for five days in
 four week cycles.
     "Once approved, Xeloda will give patients the convenience of oral dosing,
 allowing them to spend less time in the hospital and more time with their
 loved ones, while treating and managing their disease," said Georges Gemayel,
 Vice President, National Specialty Care Business Operations, at Roche.
     "Xeloda is an example of Roche's commitment to being a leader in the
 research and development of 21st century oncology drugs," said Gemayel.
 
     Xeloda:  Enzymatically-activated Therapy
     Xeloda works through enzymatic activation to the cancer-fighting substance
 5-FU.  The human body produces the enzyme thymidine phosphorylase (TP), which
 converts Xeloda into 5-FU.  Some tumors such as colorectal tumors produce more
 TP compared to healthy tissues.
     Colorectal cancer is the third most common cancer in the U.S., and
 approximately 130,000 new cases are expected this year.  About 20 percent of
 patients have metastatic (spreading to other organs or tissue) disease at the
 time of diagnosis and 50 percent of all patients with colorectal cancer will
 develop metastases and ultimately die from their disease.  The 5-year survival
 rate of patients with advanced and/or metastatic disease is less than 10
 percent.  This year alone, an estimated 56,300 people will die of colorectal
 cancer.
     In April 1998, Xeloda received accelerated approval from the FDA for the
 treatment of patients with metastatic breast cancer resistant to both Taxol(R)
 (paclitaxel) and an anthracycline-containing chemotherapy regimen such as one
 containing Adriamycin(R) (doxorubicin).  Approval of this indication was based
 on a single-arm Phase II clinical study assessing overall response rate.  As
 required by the FDA, a Phase III study comparing Xeloda and Taxotere with
 Taxotere alone has been completed and submitted for FDA review and full NDA
 approval in February of this year.
 
     Safety Information
     Xeloda is contraindicated in patients with severe renal impairment and
 those with hypersensitivity to 5-fluorouracil.  Patients with moderate renal
 impairment may warrant dose reduction.  Patients taking Xeloda with warfarin
 should be monitored regularly for alterations in PT or INR.  Patients taking
 phenytoin with Xeloda should be carefully monitored for plasma phenytoin
 levels; phenytoin dose may need to be reduced.  The most common adverse events
 are anemia, diarrhea, hand-foot syndrome, nausea, fatigue, vomiting,
 dermatitis, neutropenia, stomatitis, thrombocytopenia and hyperbilirubinemia.
 Patients with severe diarrhea should be monitored and given fluid and
 electrolyte replacement if dehydration occurs.  Significant hair loss was not
 seen with Xeloda.  As with any cancer therapy, there is a risk of side
 effects, and these are usually manageable and reversible with dose
 modification or interruption.  Visit http://www.xeloda.com or call Roche at
 1-800-526-6367 for full prescribing information.
 
     Xeloda is a registered trademark of Hoffmann-La Roche Inc.
 
     About Roche
     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 and vitamins.  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:
 dermatology; genitourinary disease; infectious diseases, including influenza;
 inflammation, including arthritis and osteoporosis; metabolic diseases,
 including obesity and diabetes; neurology; oncology; transplantation; vascular
 diseases; and virology, including HIV/AIDS and hepatitis C.
     For more information on the Roche pharmaceuticals business in the United
 States, visit the company's website at: http://www.rocheusa.com.
 
 

SOURCE Hoffman-La Roche Inc.
    NUTLEY, N.J., April 12 /PRNewswire/ -- The April 15 edition of the Journal
 of Clinical Oncology features Phase III clinical data about the use of Roche's
 Xeloda(R) (capaceitabine), an oral chemotherapy, in the first-line treatment
 of metastatic colorectal cancer, the second leading cause of cancer mortality
 among Americans.  The U.S. Food and Drug Administration is currently reviewing
 Xeloda as an oral chemotherapy for the treatment of colorectal cancer.
     The randomized Phase III clinical study published in JCO is one of the two
 phase III studies supporting the new indication for Xeloda.  This published
 study involved 605 patients with metastatic colorectal cancer.  Half the
 patients received repeated cycles of twice-daily oral doses of Xeloda at 1250
 mg/m2 given for two weeks, followed by a one-week rest period.  The other half
 of the patient group received treatment with intravenous 5-FU, 425 mg/m2 and
 leucovorin 20mg/m2 (the Mayo Regimen and a standard of care) for five days in
 four week cycles.
     "Once approved, Xeloda will give patients the convenience of oral dosing,
 allowing them to spend less time in the hospital and more time with their
 loved ones, while treating and managing their disease," said Georges Gemayel,
 Vice President, National Specialty Care Business Operations, at Roche.
     "Xeloda is an example of Roche's commitment to being a leader in the
 research and development of 21st century oncology drugs," said Gemayel.
 
     Xeloda:  Enzymatically-activated Therapy
     Xeloda works through enzymatic activation to the cancer-fighting substance
 5-FU.  The human body produces the enzyme thymidine phosphorylase (TP), which
 converts Xeloda into 5-FU.  Some tumors such as colorectal tumors produce more
 TP compared to healthy tissues.
     Colorectal cancer is the third most common cancer in the U.S., and
 approximately 130,000 new cases are expected this year.  About 20 percent of
 patients have metastatic (spreading to other organs or tissue) disease at the
 time of diagnosis and 50 percent of all patients with colorectal cancer will
 develop metastases and ultimately die from their disease.  The 5-year survival
 rate of patients with advanced and/or metastatic disease is less than 10
 percent.  This year alone, an estimated 56,300 people will die of colorectal
 cancer.
     In April 1998, Xeloda received accelerated approval from the FDA for the
 treatment of patients with metastatic breast cancer resistant to both Taxol(R)
 (paclitaxel) and an anthracycline-containing chemotherapy regimen such as one
 containing Adriamycin(R) (doxorubicin).  Approval of this indication was based
 on a single-arm Phase II clinical study assessing overall response rate.  As
 required by the FDA, a Phase III study comparing Xeloda and Taxotere with
 Taxotere alone has been completed and submitted for FDA review and full NDA
 approval in February of this year.
 
     Safety Information
     Xeloda is contraindicated in patients with severe renal impairment and
 those with hypersensitivity to 5-fluorouracil.  Patients with moderate renal
 impairment may warrant dose reduction.  Patients taking Xeloda with warfarin
 should be monitored regularly for alterations in PT or INR.  Patients taking
 phenytoin with Xeloda should be carefully monitored for plasma phenytoin
 levels; phenytoin dose may need to be reduced.  The most common adverse events
 are anemia, diarrhea, hand-foot syndrome, nausea, fatigue, vomiting,
 dermatitis, neutropenia, stomatitis, thrombocytopenia and hyperbilirubinemia.
 Patients with severe diarrhea should be monitored and given fluid and
 electrolyte replacement if dehydration occurs.  Significant hair loss was not
 seen with Xeloda.  As with any cancer therapy, there is a risk of side
 effects, and these are usually manageable and reversible with dose
 modification or interruption.  Visit http://www.xeloda.com or call Roche at
 1-800-526-6367 for full prescribing information.
 
     Xeloda is a registered trademark of Hoffmann-La Roche Inc.
 
     About Roche
     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 and vitamins.  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:
 dermatology; genitourinary disease; infectious diseases, including influenza;
 inflammation, including arthritis and osteoporosis; metabolic diseases,
 including obesity and diabetes; neurology; oncology; transplantation; vascular
 diseases; and virology, including HIV/AIDS and hepatitis C.
     For more information on the Roche pharmaceuticals business in the United
 States, visit the company's website at: http://www.rocheusa.com.
 
 SOURCE  Hoffman-La Roche Inc.