Artikel
Infusion therapy with a high dose of 5-fluorouracil/sodium-folinate in combination with mitomycin C (MMC): a dose escalation study (phase I) for patients with metastatic breast cancer
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Autoren
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Sascha Tauchert
- Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Deutschland
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Theodoros Maltaris
- Klinik für Gynäkologie und Geburtshilfe, Universitätsklinik des Saarlandes, Homburg/Saar
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Kubilay Ertan
- Klinik für Gynäkologie und Geburtshilfe, Universitätsklinik des Saarlandes, Homburg/Saar
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Klaus Diedrich
- Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Werner Schmitt
- Klinik für Gynäkologie und Geburtshilfe, Universitätsklinik des Saarlandes, Homburg/Saar
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Michael Friedrich
- Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
| Veröffentlicht: | 20. März 2006 |
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Gliederung
Text
Infusion therapy with a high dose of 5-fluorouracil/sodium-folinate in combination with MMC is an effective and well tolerated therapy regime in the treatment of gastrointestinal tumors. There it is possible to mix sodium-folinate (oncofolic®) with 5-fluorouracil in comparison with calcic folinate. As 5-fluorouracil/folic acid and MMC were used in the treatment of metastasic colon cancer in different doses, our goal was to determine the maximum tolerable dose of MMC in combination with a weekly infusion over 24 hours of 5-fluorouracil/sodium-folinate in the treatment of metastasic breast cancer patients (average of 2.8 previous therapies).
Three out of nine patients got treated with rising doses of MMC (6 – 8 – 10 mg/m2) and a fix dose of 5-fluorouracil/sodium-folinate. Mitomycin C was applicated via intravenous bolus on day 1 and 22. 5-fluorouracil (2000 mg/m2) and sodium-folinate (500 mg/m2) were given mixed together in a pump over 24h weekly over a period of six weeks (next cycle started on day 50).
There did not exist any dose limited toxicities on all of the three dose levels. The toxicities did not reach WHO grade IV. The first cycle was evaluated, the dose intensity was reached in 100%, there were no therapy delays over 7 days. In 3/9 patients a partial remission (PR) was reached, in 4/9 patients we saw a no change. Due to the experiences in the treatment of gastrointestinal tumors the dose escalation was finished at a dose level of 10 mg/m².
The combination therapy of the weekly infusion of high dose 5-fluorouracil/sodium-folinate (oncofolic®) and MMC was tolerated well and showed a good effectiveness in patients with an already treated metastasic breast cancer. Currently this project goes on in a phase II study with the maximum dose of mitomycin C 10mg/m² to find out the effectiveness and compatibility in a bigger amount of patients.
