Chemotherapy for Colorectal Cancer
Author Information
Author(s): De Placido S, Lopez M, Carlomagno C, Paoletti G, Palazzo S, Manzione L, Iannace C, Ianniello G P, De Vita F, Ficorella C, Farris A, Pistillucci G, Gemini M, Cortesi E, Adamo V, Gebbia N, Palmeri S, Gallo C, Perrone F, Persico G, Bianco A R
Primary Institution: Università Federico II, Napoli, Italy
Hypothesis
Does the addition of levamisole and folinic acid to 5-fluorouracil improve outcomes in colorectal cancer patients?
Conclusion
The addition of levamisole or folinic acid to 5-fluorouracil does not significantly improve disease-free or overall survival in patients with stage II or III colorectal cancer.
Supporting Evidence
- 1327 patients were randomised in the study.
- None of the two comparisons resulted in a significant disease-free or overall survival advantage.
- Nonhaematological toxicity was significantly worse with folinic acid.
- 5-fluorouracil remains the mainstay of adjuvant treatment for colorectal cancer.
Takeaway
This study looked at whether adding two drugs to a common cancer treatment helps patients live longer or stay cancer-free. It found that it doesn't really help.
Methodology
A multicentre, randomised phase III trial with a 2 × 2 factorial design comparing four treatment arms involving 5-fluorouracil with or without levamisole and folinic acid.
Limitations
The study may not have been powered to detect differences in specific subgroups, and the addition of folinic acid significantly increased toxicity.
Participant Demographics
Patients aged 18-75 with histologically proven, radically resected stage II or III colon or rectal cancer.
Statistical Information
Confidence Interval
HR of relapse for FA: 0.89 (95% CI: 0.73–1.09); HR of death for FA: 1.02 (95% CI: 0.80–1.30); HR of relapse for LEV: 0.99 (95% CI: 0.81–1.21); HR of death for LEV: 0.94 (95% CI: 0.73–1.20)
Digital Object Identifier (DOI)
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