Data presented at the American Society of
Clinical Oncology meeting by Professor Eric Van Cutsem, MD, PhD,
University Hospital Gasthuisberg, Leuven, Belgium, demonstrate, for
the first time, that people with metastatic colorectal cancer who
receive irinotecan hydrochloride (CPT-11 [Camptosar]) as second-line
therapy have better survival than those treated with high-dose
"These findings are significant because for the first time the
value of chemotherapy as a second-line treatment for metastatic
colorectal cancer patients has been demonstrated," said Dr. Van
Cutsem. The study shows that irinotecan may be a better therapeutic
option than best infusional 5-FU for patients who are able to receive
second-line chemotherapy, and establishes a new reference treatment.
The study is the first randomized, phase III study conducted in
metastatic colorectal cancer comparing irinotecan with high-dose
infusional 5-FU in second-line treatment following failure of
standard first-line treatment. Researchers demonstrated that at 1
year, the overall survival rate of metastatic colorectal cancer
patients who received irinotecan was 40% higher than that of patients
who received best estimated regimens of 5-FU (45% vs 32%).
This multicenter trial enrolled 267 patients with metastatic
colorectal cancer who had not responded previously to standard
first-line therapy with 5-FU. The study was designed to compare
overall survival with irinotecan to best estimated high-dose
infusional regimens of 5-FU. Patients were divided into two treatment
arms: Patients in arm A received irinotecan (350 mg/m² every 3
weeks), and patients in arm B received one of three best estimated
regimens of infusional 5-FU (5-FU, 400-mg/m²/d IV bolus plus
600-mg/m²/d IV. continuous infusion plus folinic acid; 5-FU, 250
to 300-g/m²/d IV continuous infusion until toxicity; or 5-FU,
2.6 to 3 g/m²/d over 24 hours with folinic acid weekly × 6
weeks followed by a 2-week rest).
At 1 year, the overall survival rates were 45% in the irinotecan arm
vs 32% in the 5-FU arm (P = .035).
Quality-of-life analysis did not show a difference between the
irinotecan and 5-FU arms measured by the frequency of symptoms, such
as pain, nausea, weight/appetite loss, and emotional functioning.
Diarrhea and vomiting were slightly less prevalent in the 5-FU arm.
The most common adverse effects of irinotecan observed in this study
were diarrhea, neutropenia, and vomiting. These results indicate that
patients receiving irinotecan can live longer with a good quality of life.
Colorectal cancer is one of the leading cancers in the western world.
Each year more than 180,000 new cases of colorectal cancer are
diagnosed in Europe and more than 130,000 new cases are diagnosed in
the United States. Up to 50% of patients may be cured with surgery,
but many develop metastases. Approximately 25% of patients will
respond to standard first-line treatment with 5-FU. Until now, no
good treatment options were available for patients who proved
unresponsive to this standard treatment.