Combining 5-Fluorouracil and Mitomycin C for Gastrointestinal Cancer
Author Information
Author(s): Hartmann J T, Oechsle K, Quietzsch D, Wein A, Hofheinz R D, Honecker F, Nehls O, Köhne C-H, Käfer G, Kanz L, Bokemeyer C
Primary Institution: Eberhard-Karls-Universität, Tübingen, Germany
Hypothesis
What is the maximum tolerated dose of mitomycin C when combined with continuous infusional 5-fluorouracil and high-dose folinic acid?
Conclusion
The combination of infusional 5-fluorouracil plus folinic acid and bolus mitomycin C is safe and well-tolerated, showing some antitumor activity in pretreated gastric cancer patients.
Supporting Evidence
- 16 patients were treated in the phase I part of the study, and 45 patients were included in the phase II part.
- The maximum tolerated dose of mitomycin C was determined to be 10 mg/m².
- 7 patients (16%) achieved an objective response to the treatment.
- Median overall survival was 7.1 months for gastric cancer patients.
- Thrombocytopenia was the most frequent severe toxicity observed.
Takeaway
Doctors tested a new cancer treatment using two medicines together to see if they work better than one alone. They found it was safe and helped some patients feel better.
Methodology
This was a nonrandomised multicentre phase I/II study to determine the maximum tolerated dose of mitomycin C in combination with continuous infusional 5-FU and high-dose folinic acid.
Limitations
The study was nonrandomised and included a small sample size, which may limit the generalizability of the results.
Participant Demographics
The study included 61 patients with advanced gastrointestinal cancer, with a median age of 59 years, and a majority were male (82%).
Statistical Information
Confidence Interval
CI95% 21–79 for gastric cancer response rate
Digital Object Identifier (DOI)
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