Monday, September 20, 2004

IN BRIEF: THE SANOFI-AVENTIS GROUP

The Sanofi-Aventis Group received approval to market pharma name Eloxatin (oxaliplatin) in Europe for the adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumor. An application for a similar indication was submitted to the Food and Drug Administration in early 2004, Sanofi-Aventis said. The pharmaceutical brand drug is currently approved in the United States for the first-line treatment of metastatic carcinoma of the colon or rectum in combination with 5-fluorouracil and leucovorin.

Friday, June 11, 2004

XELODA PLUS ELOXATIN MAY BE EFFECTIVE COLORECTAL CANCER TREATMENT

F. Hoffman-La Roche Ltd.'s Xeloda (capecitabine) plus Sanofi-Synthelabo Inc.'s Eloxatin (oxaliplatin) appears to be an effective treatment for metastatic colorectal carcinoma, research shows.

Investigators sought to determine the effect of Xeloda plus pharma brand Eloxatin on tumor growth in a human colon cancer xenograft model.

The study included 96 patients with metastatic or locally advanced colorectal cancer.

In a three-week treatment cycle, the subjects received intravenous Eloxatin 130 mg/m2 on day one followed by oral Xeloda 1,000 mg/m2 twice per day from the evening of day one to the morning of day 15, followed by a seven-day treatment-free phase. A median of eight cycles was administered.

According to the results, 53 of the 96 patients experienced an objective treatment response. Thirty of the subjects achieved disease stabilization for at least three months following the regimen.

The median time to disease progression was 7.7 months and the median overall survival was 19.5 months after a minimum of 24 months of follow-up. The survival rates at one and two years were 70 percent and 30 percent, respectively.

The authors noted that the majority of treatment-related adverse events were mild to moderate in intensity. Sensory neuropathy occurred in 85 percent of the subjects; only 17 percent of these subjects experienced cumulative neurotoxicity (grade 3 or 4).

The data appear in the June 1 issue of the Journal of Clinical Oncology.