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European Studies Compare Combination Regimens Against Advanced Colorectal Cancer

European Studies Compare Combination Regimens Against Advanced Colorectal Cancer

NANTES, France—European researchers are moving beyond colorectal cancer
regimens based on infusional fluorouracil (5-FU) to comparing combinations and
to examining the effects of scheduling on response and time to progression,
according to Jean-Yves Douillard, MD, PhD. Professor Douillard, who developed a
widely-used regimen for colorectal cancer, is professor of medical oncology and
head of the department of medical oncology, Centre Rene Gauducheau, at the
University of Nantes in France.

European clinicians view the value of chemotherapy for colorectal cancer as
well established and favor infusional over bolus 5-FU, according to Professor
Douillard. "A combination of fluorouracil, leucovorin, and irinotecan (CPT-11,
Camptosar) or oxaliplatin (Eloxatin) is now becoming standard therapy," he
said. "Most use a simplified de Gramont regimen, with a 5-FU bolus of 400 mg/m2
followed by 5-FU at 2.4 to 3.6 g/m2 over 46 hours, repeating every 2
weeks" (see Table 1).

Ongoing European studies in advanced colorectal cancer include comparisons
between single agent 5-FU/leucovorin and various combinations and comparisons
of combinations. European researchers are also experimenting with variations in
drug scheduling, either in exclusive chemotherapy or in combination with
surgery for resectable patients.

Ongoing Trials Summarized

Professor Douillard summarized these ongoing trials.

A German trial is comparing the German AIO regimen (2,600 mg/m2
5-FU given as a 24-hour infusion plus 500 mg/m2 leucovorin weekly x
6 with 1 week rest, continuing for 18 weeks to the same regimen plus irinotecan
at 80 mg/m2/week, but with the 5-FU dose reduced to 2,000 mg/m2.
Preliminary results of this 430-patient trial, which were presented at the 2002
American Society of Clinical Oncology meeting (Kohne et al, ASCO abstract 532)
showed a median progression-free survival of 8.5 months for the irinotecan arm
vs 6.5 months for the 5-FU/leucovorin arm (P < .0001). "This is one of
the longest time to progression periods reported so far in this population of
patients," Professor Douillard said.

An ongoing UK study (FOCUS) in 2,100 patients is comparing five regimens:

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