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Orlando, Florida: New data presented today by researchers from the National Surgical Adjuvant Breast and Bowel Project (NSABP) announced findings from Protocol C-07 that show combining the drug oxaliplatin to conventional treatment of 5-FU plus leucovorin significantly improves disease-free survival in patients with stage II or III colon cancer. The results were announced at the annual meeting of the American Society of Clinical Oncology (ASCO). Support for the study was provided by the National Cancer Institute (NCI).

"This is good news. These results will influence the standard of care for stage II and III patients with colon cancer," said Norman Wolmark, MD, chair of the NSABP and chairman of the Department of Human Oncology at Allegheny General Hospital in Pittsburgh, Penn.

This multi-center, prospective, randomized trial involved 2,407 patients with stage II and III colon cancer. Patients were randomly assigned to receive either FULV (5-FU, 500mg/m2 iv bolus weekly x 6; LV, 500mg/m2 iv weekly x 6, each 8 week cycle x 3) or FLOX (the same FULV regimen with oxaliplatin 85 mg/m2 iv administration on weeks 1, 3, and 5 of each 8 week cycle x 3). The primary aim was to determine whether FULV plus oxaliplatin (FLOX) would prolong 3-year disease-free survival compared to FULV. Researchers noted a 21% risk reduction in favor of FLOX after a median follow-up of thirty-four months. Sanofi-Aventis provided the oxaliplatin for this study.

"We should acknowledge the support and participation of the many community physicians who placed their patients in this trial, said Phil Kuebler, MD, C-07 protocol chairman and principal investigator of the Columbus Community Clinical Oncology Program. It takes courage and trust to enter a randomized research trial, but our patients have truly helped the NSABP to advance the treatment of colon cancer."

Eloxatin® (oxaliplatin) background information

" Eloxatin® in combination with 5-fluorouracil (5FU) and folinic acid (FA) is indicated for
- Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumour
- Treatment of metastatic colorectal cancer1

" Eloxatin®, in combination with 5FU/FA, has been shown to extend progression-free survival in metastatic (advanced) colorectal cancer (from a median survival of 6.2 to 9 months)2

" In early stage colon cancer, adjuvant (post-operative) treatment with Eloxatin® in combination with 5FU/FA has been shown to reduce the risk of recurrence of the cancer by 25% compared to standard treatment with 5FU/FA.4 Reducing the rate of recurrence increases the chances of a cure

Eloxatin® in the adjuvant setting

" Surgery has been the treatment of choice for early colon cancer but up to 50% of patients eventually relapse and die from metastatic disease following surgery alone.4 This had led to the use of post-operative chemotherapy (also known as adjuvant chemotherapy) in order to reduce the risk of recurrence

" In September 2004, Eloxatin® received European marketing approval for the adjuvant treatment of stage III colon cancer in combination with 5FU/FA and in October 2004 this indication was approved in the UK

" In adjuvant treatment of colon cancer Eloxatin® has been shown to deliver the following efficacy:
- After a minimum of at least 3 years (and median follow-up of 4.5 years), 3-year disease-free survival was 72.8% in the Eloxatin/5FU/LV arm and 65.8% in the 5FU/LV arm, a 7.0% absolute difference3

- The 4-year disease-free survival data showed 69.7% in the Eloxatin/5FU/LV arm and 61.0% in the 5FU/LV arm, an 8.7% absolute difference, which corresponds to a 25% relative reduction in the risk of relapse4

" The NICE technology appraisal of Eloxatin® as adjuvant chemotherapy is currently in development and the publication of this guidance is anticipated in May 2006