Gefitinib in Colorectal Cancer
Author Information
Author(s): Veronese M L, Sun W, Giantonio B, Berlin J, Shults J, Davis L, Haller D G, O'Dwyer P J
Primary Institution: Abramson Cancer Center at the University of Pennsylvania
Hypothesis
The study aims to determine the tolerability and efficacy of gefitinib in combination with irinotecan, infusional 5-fluorouracil, and leucovorin in patients with advanced colorectal cancer.
Conclusion
The combination of gefitinib with standard chemotherapy for colorectal cancer resulted in excessive toxicity and modest efficacy.
Supporting Evidence
- 10 out of 13 patients required dose reductions due to toxicity.
- One patient achieved a partial response, while seven had disease stabilization.
- 54% of patients experienced grade 3 or 4 gastrointestinal toxicity.
Takeaway
This study tested a new cancer treatment but found that it made many patients very sick and didn't work much better than existing treatments.
Methodology
A phase II nonrandomised trial assessing the safety and efficacy of gefitinib combined with irinotecan, 5-FU, and LV in patients with advanced colorectal cancer.
Potential Biases
The small sample size may limit the generalizability of the findings.
Limitations
The study had a small sample size and was closed early due to excessive toxicity.
Participant Demographics
13 patients, 6 male and 7 female, aged 49 to 72 years, with advanced or recurrent colorectal adenocarcinoma.
Statistical Information
P-Value
p<0.05
Confidence Interval
95% CI 0–38% for partial response, 95% CI 28–85% for disease stabilization
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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