Metronomic Irinotecan in Colorectal Cancer
Author Information
Author(s): Allegrini G, Falcone A, Fioravanti A, Barletta M T, Orlandi P, Loupakis F, Cerri E, Masi G, Di Paolo A, Kerbel R S, Danesi R, Del Tacca M, Bocci G
Primary Institution: University of Pisa, Pisa, Italy
Hypothesis
The study aims to investigate the pharmacokinetic and pharmacodynamic profile of metronomic irinotecan in patients with metastatic colorectal cancer.
Conclusion
Metronomic irinotecan is well tolerated and can induce an increase in thrombospondin-1 levels in patients with metastatic colorectal cancer.
Supporting Evidence
- Four patients (20%) achieved stable disease for a median of 3.9 months.
- Toxicities greater than grade 1 were not observed.
- Significant increases in thrombospondin-1 levels were noted during treatment.
Takeaway
This study looked at a new way to give a cancer drug called irinotecan, and it found that giving it in small doses over a long time is safe and can help some patients.
Methodology
The study involved continuous intravenous infusion of irinotecan at three different dose levels in chemotherapy-refractory patients, with pharmacokinetic and pharmacodynamic assessments.
Potential Biases
The study was not randomized, which may introduce bias in the results.
Limitations
The study was exploratory and not comparative, limiting the ability to draw definitive conclusions about efficacy.
Participant Demographics
Median age was 71 years, with a range of 51-79 years; 11 males and 9 females.
Statistical Information
P-Value
p<0.05
Confidence Interval
95% CI: 1.99–2.14 for PFS; 95% CI: 5.1–11.7 for OS
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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