Irinotecan plus Fluorouracil and Leucovorin for Metastatic Colorectal Cancer
- Study type
- Clinical trial
- Study name
- Irinotecan Study Group
- Design
- Randomised multicentre trial with three treatment arms (first-line treatment)
- Sample size
- 683 patients
- Source
- N Engl J Med · 2000
In plain words
In this study, patients with bowel (colorectal) cancer that had spread to other parts of the body were given, as their first treatment, either two older drugs (fluorouracil and leucovorin), the same two drugs plus irinotecan, or irinotecan alone. Adding irinotecan kept the disease from growing for longer, and patients lived longer on average. Severe diarrhoea was more common with the three-drug treatment, but patients' quality of life did not get worse.
Key results
Treatment arms and regimens
Irinotecan 125 mg/m² IV, fluorouracil 500 mg/m² IV bolus and leucovorin 20 mg/m² IV bolus, weekly for four weeks every six weeks.
Fluorouracil 425 mg/m² IV bolus and leucovorin 20 mg/m² IV bolus, daily for five consecutive days every four weeks.
Irinotecan 125 mg/m² IV, weekly for four weeks every six weeks.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with metastatic colorectal cancer receiving first-line treatment. Other eligibility criteria are not stated in the abstract.
Endpoints
Endpoints included progression-free survival and overall survival. Confirmed response and quality of life were also assessed.
Safety and side effects
Grade 3 (severe) diarrhoea was more common with irinotecan, fluorouracil and leucovorin than with fluorouracil and leucovorin, but grade 4 (life-threatening) diarrhoea was similar in the two groups (under 8%). Grade 3 or 4 mucositis, grade 4 neutropenia and febrile neutropenia were less frequent with irinotecan, fluorouracil and leucovorin. Adding irinotecan to fluorouracil and leucovorin did not compromise quality of life.
Clinical significance and place in guidelines
According to the abstract, adding weekly irinotecan to fluorouracil and leucovorin as first-line treatment of metastatic colorectal cancer improved progression-free and overall survival compared with fluorouracil and leucovorin alone. The current status of this regimen in clinical guidelines and drug approvals should be checked separately, as the abstract does not address it.
Limitations
The abstract does not discuss the study's limitations. The comparator was a bolus fluorouracil and leucovorin regimen. Further details of eligibility criteria and subgroup analyses are in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.