Dr Claus-Henning Köhne and colleagues examined prolonging progression-free survival.
The investigative team added irinotecan to a standard weekly schedule of high-dose, infusional fluorouracil and leucovorin/folinic acid.
The team randomly assigned 430 patients with measurable or assessable metastatic colorectal cancer.
The patients received either folinic acid 500 mg/m2 as a 2-hour infusion or fluorouracil 2.6 g/m2 by intravenous 24-hour infusion.
Both treatments were administered weekly for 6 weeks, and then patients were divided into 2 groups.
|The response rate was 62% in the experimental group vs 34% in the placebo arm|
|Journal of Clinical Oncology|
Patients in Group 1, the placebo arm, had a 2-week rest period after their initial treatments.
Group 2, the experimental group, had a similar initial schedule but then received fluorouracil 2 g/m2 preceded by irinotecan 80 mg/m2 administered over 30 minutes.
The investigators found that the median progression-free survival time in Group 2, the experimental group, was 9 months vs 6 months in Group 1.
The investigative team noted that the median overall survival time increased from 17 to 20 months.
The objective response rate was 62% in Group 2, the experimental group, and 34% in Group 1.
Dr Köhne's team concludes, “Addition of irinotecan to the standard fluorouracil/folinic acid regimen was associated with a highly significant improvement in progression-free survival and response rate and was well tolerated.”
“The results of this study confirm that irinotecan in combination with high-dose infusional fluorouracil/folinic acid is a reference first-line treatment.”