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Health Canada Approves Xeloda (Capecitabine) for Adjuvant Therapy in the Treatment of Colon Cancer

Colon cancer patients now have access to a new effective and more convenient treatment

MISSISSAUGA, CANADA -- March 28, 2006 - Hoffmann-La Roche Ltd. announced today that Health Canada has approved Xeloda (capecitabine), an innovative oral chemotherapy, for the adjuvant treatment of patients with stage III (Dukes' stage C) colon cancer based on the promising clinical evidence that it may be useful in the treatment of patients with this serious disease.

Adjuvant chemotherapy is the standard treatment approach for stage III colon cancer (Stage III or Dukes' Stage C is cancer that has spread to the lymph nodes), where chemotherapy is given after the tumour has been surgically removed.

This approval will now give patients who have undergone complete resection of their primary tumour the option of an oral chemotherapy, when treatment with fluoropyrimidine therapy alone is preferred. Xeloda as an oral fluoropyrimidine can be taken at home and compares favourably with intravenous infusion which requires multiple hospital visits.

"Thousands of Canadians will be diagnosed with colon cancer this year. Therefore, it remains extremely important that current treatment methods are further researched and improved for these patients," said Dr. Jean Maroun, Medical Oncologist, The Ottawa Hospital Regional Cancer Centre. "This approval for Xeloda is exciting for both doctors and colon cancer patients because it offers an additional, effective and well-tolerated treatment option that does not have to be administered in a hospital setting, but can conveniently be taken at home."

Health Canada's decision was based on the landmark X-ACT (Xeloda in Adjuvant Colon Cancer Therapy) trial. The trial successfully met its primary endpoint showing Xeloda to be at least equivalent to intravenous 5-fluorouracil/leucovorin (5FU/LV) in disease-free survival with a trend towards superiority in disease-free survival for Xeloda(1). The median follow-up at time of analysis was 3.8 years and showed that 64% of the patients on Xeloda were still disease free, with the convenience of an at-home treatment (compared to 61% of patients who were disease free on standard intravenous fluoropyrimidine treatment).

Xeloda was approved under Health Canada's notice of compliance with condition (NOC/c) policy. Medications approved under this policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. The X-ACT trial is ongoing and further follow-up of patients to 5 years is required by Health Canada to confirm the long-term efficacy and safety of Xeloda in the adjuvant setting.

Improved Cost Effectiveness
On average, a patient only required eight hospital visits when treated with Xeloda compared to 30 visits if treated with i.v. 5-FU/LV(2). This results in significant cost savings - an important advantage for doctors, nurses and pharmacists in today's healthcare environment. Roche has a large ongoing study program looking at Xeloda in combination with other chemotherapies and targeted therapies in breast and colon cancer.

About Colorectal Cancer
In Canada, approximately 19,600 new cases of colorectal cancer will be diagnosed this year, with approximately 8,400 Canadians dying from the disease(3). It affects both men and women equally. On average, 377 Canadians will be diagnosed with colorectal cancer every week. One in 14 men is expected to develop colorectal cancer during their lifetime, and one in 28 will die of it. One in 16 women is expected to develop colorectal cancer during their lifetime, and one in 31 will die of it.

About Xeloda(R)
Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Xeloda was equivalent to 5-FU/LV for disease-free survival (DFS). Xeloda was approved by Health Canada for the treatment of advanced or metastatic breast cancer in 1998, metastatic colorectal cancer in 2000, and in combination with Taxotere for metastatic breast cancer in 2001.


REFERENCES:
(1) Reddy, G. Efficacy of adjuvant capecitabine compared with bolus 5-Fluorouracil/Leucovorin regimen in Dukes C colon cancer: results from the X-ACT trial. Clin Colorectal Cancer, July 2004: 87-88.
(2) McKendrick, J.J, Cassidy, J, et al. Capecitabine (*) is resource saving compared with i.v. bolus 5-FU/LV in adjuvant chemotherapy for Dukes' C colon cancer patients: Medical resource utilization (MRU) data from large phase III trial (X-ACT). Journ of Clin Oncol, 2004 ASCO Annual Meeting Proceedings (Post Meeting Edition). Vol 22, No 14S (July supplement), 2004: 3578.
(3) Health Canada. Screening for colorectal cancer. (online) 2002 (cited 2005 August 25). Available from: URL: http//www.hc-sc.gc.ca/english/iyh/diseases/colorectal.html


SOURCE: Roche Canada

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