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Irinotecan: toward clinical end points in drug development
1University of Texas, M.D. Anderson Cancer Center, Houston, USA.
Oncology (Williston Park, N.Y.)
|September 3, 1998
Summary
Irinotecan improves survival and quality of life in advanced colorectal cancer patients resistant to 5-fluorouracil. Randomized trials confirm its clinical benefit beyond initial response rates.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Objective response rate is an initial measure for novel anticancer agents.
- Response rates may not fully capture clinical benefit, especially with toxicity.
- Clinical endpoints like survival and symptom relief offer a better basis for therapy selection.
Purpose of the Study:
- To evaluate the clinical utility of irinotecan (CPT-11) in 5-fluorouracil (5-FU)-refractory colorectal cancer.
- To assess irinotecan's impact on survival, quality of life, and symptom control in randomized phase III trials.
Main Methods:
- Two randomized phase III trials were conducted.
- Trial 1: Irinotecan plus best supportive care (BSC) vs. BSC alone in 5-FU-resistant metastatic colorectal cancer.
- Trial 2: Irinotecan vs. infusional 5-FU in colorectal cancer patients with recent 5-FU progression.
Main Results:
- Irinotecan significantly prolonged survival and improved quality of life and symptom control compared to BSC.
- Irinotecan-treated patients lived significantly longer than those receiving infusional 5-FU, with comparable quality of life.
Conclusions:
- Randomized trials demonstrate irinotecan's significant clinical benefit in 5-FU-refractory colorectal cancer.
- Irinotecan offers improved survival and quality of life, establishing its role beyond response rates.