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MOSAIC Study: Oxaliplatin Decreases Risk of Relapse After Surgery From Colorectal Cancer

CHICAGO, June 1 /PRNewswire/ -- Efficacy results of the MOSAIC (Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer) trial were presented at the 39th annual meeting of the American Society of Clinical Oncology (ASCO). This pivotal trial showed that the addition of oxaliplatin to the current standard of post-operative (adjuvant) chemotherapy for colon cancer reduces the risk of recurrence by 23% in patients who have undergone surgery for their primary tumor.

"Oxaliplatin is the first agent which, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), shows a significant benefit over the current standard treatment in adjuvant colon cancer. 5FU has been the mainstay in adjuvant therapy for more than 15 years. Thus, these results represent a major step forward in curing a greater number of patients," said Aimery de Gramont MD, Professor of Medicine, Director of the Oncology Department, Saint Antoine Hospital and University, Paris, Chairman of the GERCOR Group and Principal Investigator of the MOSAIC study, who added that "The first step to cure patients is to avoid relapse."

MOSAIC is a large, international, randomized phase III trial which enrolled 2,246 patients in 20 countries. It was based on the assumption that an optimal treatment in metastatic colon cancer(1,2) could also benefit patients with early-stage, localized disease. The primary objective of the trial was to evaluate the time to relapse (Disease Free Survival) in patients who have undergone surgery for their primary tumor and received standard 5-FU/LV post-operative chemotherapy with or without the addition of oxaliplatin.

MOSAIC demonstrated that adding oxaliplatin to standard treatment significantly reduced the number of relapses or deaths after initial surgery (relative risk reduction=23%; p

"What is impressive about these results is the shape of the Disease Free Survival curves. They diverge from the outset and remain separated throughout the observation period. The clear-cut design of the study makes it possible to establish that the difference observed is really due to oxaliplatin," said Marc Buyse, ScD, Senior Statistician, Executive Director of the International Drug Development institute (IDDI) and member of the data monitoring committee of the MOSAIC study. He also pointed out that the statistical hypotheses of the trial were verified and that the treatment affect was observed in all subsets of patients.

The safety results of the MOSAIC trial were first presented and discussed at the 38th annual ASCO meeting in May 2002, Orlando, FL(3). The addition of oxaliplatin to 5-FU and LV is well tolerated. Neutropenia (decrease in white blood cells) was the most frequently reported side effect but it was complicated by fever in only 0.7% of cases. Among patients experiencing peripheral sensory neuropathy (numbness, "pins and needles" in the fingers), partial or total recovery was observed in almost all cases within a period of 6 months following treatment.

Colorectal cancer is the second leading cause of cancer-related deaths worldwide with about 900,000 new cases diagnosed each year. Although 80% of patients present no evidence of residual tumor after surgery, 30% to 40% of them relapse and ultimately die from subsequent metastatic disease even when they have received standard adjuvant chemotherapy. Currently, 6 months of 5-FU/LV is the standard adjuvant treatment for colon cancer(4,5).

The MOSAIC study was supported by a grant from Sanofi-Synthelabo. A total of 148 centers participated in the trial, including selected centers from the GERCOR group.

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