Sanofi-Synthelabo recently announced that its platinum-based drug oxaliplatin (Eloxatin) has been approved by the US Food and Drug
Administration (FDA) for use in combination with infusional fluorouracil (5-FU)/leucovorin
in advanced colorectal cancer patients whose disease has recurred or progressed
after bolus 5-FU/leucovorin plus irinotecan (CPT-11, Camptosar) therapy. The FDA
approval is based on the response rate and improved time to tumor progression
observed in an ongoing trial. Data that demonstrate a clinical benefit, such as
improvement in disease-related symptoms or an increase in survival are not yet
In the pivotal investigation, oxaliplatin in combination with
infusional 5-FU/leucovorin demonstrated a statistically significant response
rate compared with infusional 5-FU/leucovorin alone. Additionally, interim data
from the investigation on the median time to disease progression showed an
increase of 2 months with the oxaliplatin combination, compared to
infusional 5-FU/leucovorin alone.
"Eloxatin in combination with infusional 5-FU/leucovorin
provides an alternative for patients who previously had only limited
options," said Mace Rothenberg, md, lead investigator for the trial and
Ingram Associate Professor of Cancer Research at the Vanderbilt-Ingram Cancer
Center, Vanderbilt University, Nashville, Tennessee. In addition, he noted,
"oxaliplatin is being evaluated for its impact on disease-related symptoms
including pain, weight loss, fatigue, and its effect on survival."
Dan Haller, md, professor of medicine at the University of
Pennsylvania Cancer Center, and who directs other clinical studies with
oxaliplatin, said, "Eloxatin in combination with infusional 5-FU/leucovorin
adds a new weapon to what has been a very small arsenal of effective treatments
for advanced colorectal cancer. In patients whose advanced colorectal cancer has
recurred or progressed, meaningful options have been few." He added,
"The approval of Eloxatin may change the way we treat our patients."
Clinical Trial Results
The New Drug Application for oxaliplatin was based on the
results of a US-Canadian multicenter, randomized, controlled investigation. This
study compared the safety and efficacy of oxaliplatin plus infusional 5-FU/leucovorin
with that of infusional 5-FU/leucovorin alone and oxaliplatin alone.