Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Moser, R; Hausmaninger, H; Ludwig, H; Fridrik, M; Schmidt, H; Mlineritsch, B; Pecherstorfer, M; Michlmayr, G; Kopf, C; Samonigg, H.
5-Fluorouracil and Folinic Acid with or Without Alpha-2C Interferon in the Treatment of Metastatic Colorectal-Cancer - Preliminary-Results of a Multicenter Prospective Randomized Phase-III Trial
ONKOLOGIE 1995 18: 131-135.
Doi: 10.1159/000218573
Web of Science
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- Führende Autor*innen der Med Uni Graz
- Schaberl-Moser Renate
- Co-Autor*innen der Med Uni Graz
- Samonigg Hellmut
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- Abstract:
- Background: For treatment of advanced colorectal cancer sufficient data exist confirming the efficacy of biochemical modulation of 5-fluorouracil (5FU) by folinic acid (FA). Several randomized clinical trials demonstrated a higher objective tumor response for 5FU/FA in comparison with 5FU alone. Thus the 5FU/FA regimen is recommended as treatment of first choice in metastatic colorectal cancer. Based on recent data showing that alpha-2c interferon (IFN) modulates and thereby enhances the cytotoxic effects of 5FU, the present trial was conducted to evaluate the concomitant use of IFN with 5FU/FA with regard to efficacy and toxicity. Patients and Methods: 218 patients with measurable, progressive metastatic colorectal cancer, previously untreated for advanced disease, were enrolled in this trial. They were randomly assigned to receive either treatment with FA 100 mg/m(2) as an i.v. infusion over 15 min immediately followed by 5FU 500 mg/m(2) as an i, v. infusion over 30 min for 4 days and later on once weekly for 7 weeks (arm A) or with FA and 5FU in the same schedule plus IFN 7 million units s. c. 3 times per week (arm B). Results: So far 186 patients are evaluable for assessment of response, in group A 95 and in group B 91 patients. Overall response rate is 25 % for the 5FU/FA arm and 38% for the IFN arm (p=0.067). Median time to disease progression is 150 days vs 200 days (p=0.18), median survival is 13 vs 10 months (p=0.07). Toxicity was mild, mainly restricted to WHO grades I and II, but was reported more often for the IFN arm, especially concerning loss of appetite, fever, flu-like syndrome, fatigue and diarrhea. Major toxicity grades III and IV was rare, there was no treatment-related death. Conclusions: Results of this interim analysis show no statistically significant difference between the two treatment modalities with regard to response rate and survival. It will be of interest whether an observed trend for improved survival (p=0.07) and less toxicity for the 5FU/FA group will be confirmed by a longer follow-up period.
- Find related publications in this database (Keywords)
- Colorectal Carcinoma
- Metastatic
- 5-Fluorouracil
- Interferon
- Folinic Acid
- Biochemical Modulation