EloxatinT demonstrates significant benefit over standard therapy in early stage
colon cancer
03 Jun 2004



EloxatinT Based Adjuvant Chemotherapy Provides 23 Percent Reduction in Risk of
Colon Cancer Recurrence.

Results of an ELOXATIN (oxaliplatin for injection) adjuvant trial (MOSAIC) have
been published in the current issue of the New England Journal of Medicine. The
trial demonstrated that the addition of ELOXATINT to the current standard of
adjuvant chemotherapy for colon cancer (5-fluorouracil/leucovorin known as
5-FU/LV) reduced the risk of recurrence of cancer by 23 percent in patients who
had undergone surgical removal of their primary tumor(i).

These are the first results to demonstrate a significant benefit over 5-FU/LV
alone, and provide early-stage colon cancer patients with new hope for potential
cure of their disease.

The MOSAIC study is a large, international, randomized phase III trial involving
2,246 patients in 148 centers, led by Dr. de Gramont, Professor of Medicine and
Director of the Oncology Department, Saint-Antoine Hospital, Paris.

The MOSAIC trial was based on the assumption that the ELOXATIN-based
chemotherapy regimen, a standard treatment for patients with advanced metastatic
colon cancer, would also benefit patients with early-stage disease who have had
surgical removal of their tumor.

The primary objective of the trial was to demonstrate the superiority of
ELOXATIN-based chemotherapy over standard therapy alone, using as a primary
end-point, three-year disease-free survival (the percentage of patients alive
without colon cancer three years after treatment).

The FDA's Oncologic Drugs Advisory Committee (ODAC) recently endorsed 3-year
Disease Free Survival as a valid endpoint for early colon cancer treatment
trials.

"The MOSAIC results show that this ELOXATIN-based therapy is the first
significant development for the adjuvant management of early colon cancer in 10
years," said Dr. de Gramont(ii). "By adding ELOXATIN to standard chemotherapy,
we see a significant improvement in three-year disease free survival. These
results, in addition to the recent first-line approval, demonstrate the value of
ELOXATIN across the continuum of care for colon cancer patients."

After a median follow-up of 37 months, 3-year disease-free survival was 72.9 %
in the 5-FU/LV arm and 78.2 % in the Eloxatin/5-FU/LV arm, which corresponds to
a 23% reduction in the risk of relapse. In the Eloxatin arm, the most frequently
reported side effects were neutropenia (decrease in white blood cells) that was
complicated by fever or infection in 1.8% of cases, diarrhea and peripheral
sensory neuropathy (numbness, "pins and needles" in the extremities).

The incidence of significant sensory neuropathy was 12% during the study but
this improved when patients discontinued treatment, with only 0.5% having
significant symptoms 18 months later.

On the basis of the MOSAIC trial a supplemental New Drug Application (sNDA) was
submitted to the FDA in the US in early 2004 as well as an extension of
indication to EMEA in Europe for ELOXATIN to include the adjuvant treatment of
patients with colon cancer.

"The MOSAIC data represent significant incremental gain in the comprehensive
management of colon cancer. The data unequivocally demonstrate that oxaliplatin
is an active agent in the adjuvant setting and suggest that oxaliplatin
containing regimens should become an accepted standard of care," said Dr. Norman
Wolmark, MD, Chairman, Department of Human Oncology, Allegheny General Hospital,
Pittsburgh.

In the United States alone, approximately 60,000 patients present with early
stage colon cancer every year.

The National Comprehensive Cancer Network (NCCN), an alliance of 19 of the
world's leading cancer centers, recently updated its colon and rectal guidelines
to account for the current evidence surrounding ELOXATIN-based therapies.
[http://www.nccn.org]

The MOSAIC trial was supported by a grant from Sanofi-Synthelabo

http://www.medicalnewstoday.com/?newsid=9047

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