News
More cancer patients to be treated with Eloxatin(R) following Health Canada's approval of new indication
Health Canada has approved Eloxatin(R) (oxaliplatin for injection), in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOX4), for the adjuvant (post-surgical) treatment of patients with stage III colon cancer, after complete resection of the primary tumour. This indication is based on a demonstrated improvement in disease-free survival. Data also show a umerical improvement in overall survival after six years.
"Colorectal cancer has had a profound impact on my life and the lives of thousands of Canadians who, up until this point, have had few treatment options," says Neil Crone, Canadian actor and colorectal cancer survivor. "Canadians with colorectal cancer are fortunate to have this new treatment which provides hope for a successful recovery."
Colon cancer grows very slowly and oncologists have found that this growth is often predictable, making it simpler to treat when detected early. "The approval of Eloxatin for use after surgery provides my patients with the hope that they can better their chances of being cancer-free," says Dr. Yoo-Joung Ko, a Toronto-based oncologist. "The safety and efficacy profile of Eloxatin is clinically superior to the previous standard treatment, making this an important advancement in the treatment of the disease."
Barry D. Stein, president of the Colorectal Cancer Association of Canada, acknowledges the need for new treatment options. "My personal battle with colorectal cancer has been extremely challenging and I'm thankful that I am in a position where there is no evidence of the disease," he says. "With so many Canadians being diagnosed with colorectal cancer, the approval of Eloxatin for use in the earlier stages of the disease provides an additional opportunity for patients to prolong their lives. It brings hope to patients, their families and friends."
Clinical Data
Health Canada's approval of Eloxatin was based on clinical data collected over several years. The Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial compared the efficacy and evaluated the safety of Eloxatin in combination with an infusional schedule of 5-FU/LV (FOLFOX4) to infusional 5-FU/LV alone, in patients with stage II or III colon cancer who had undergone complete resection of the primary tumour. In the overall study population, disease-free survival was statistically and significantly improved in the Eloxatin combination arm compared to infusional 5-FU/LV alone.(1) Survival data at six years show a numerical improvement in overall survival in patients with stage III colon cancer.