Phase II trial of 5-fluorouracil and the natural l isomer of folinic acid in the treatment of advanced colorectal carcinoma

R. Rosso, T. Mazzei, A. Sobrero, E. Mini, G. Cartei, P. Conte, R. Labianca, F. Cartei, A. Falcone, G. Pancera, G. Barsanti, F. Di Costanzo, A. Guglielmi, E. Bolli, L. Tixi, C. Aschele, A. Ribecco, P. Periti

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Abstract

Between February 1991 and July 1992, 79 previously untreated patients with metastatic colorectal carcinoma were enrolled in a phase II study of combined 5-fluorouracil (5-FU) and l-folinic acid (FA). 5-FU 370 mg/m2/day was administered for 5 consecutive days as an intravenous (i.v.) bolus injection preceded by l-FA 100 mg/m2/day with the same administration modality. Treatment was given every 4 weeks until progression. 79 patients were evaluable for toxicity and 64 for response. 2 patients (3%) achieved a complete remission and 8 (12.5%) a partial remission, 33 (52%) had stable disease and 21 patients (33%) had progressive disease. Median duration of remission was 32.5 weeks and median survival for all evaluable patients was 64.5 weeks. Substantial to severe side-effects occurred in 39% of patients. Dose-limiting toxicity (grade 3-4) was mainly diarrhoea (18%) and mucositis (15%). Nausea/vomiting, cutaneous toxicity, leucopenia, alopecia and conjunctivitis of grade 3-4 occurred respectively in 6, 4, 2.5, 1 and 1% of cases. Toxicity appeared to be substantially similar to that characteristic of combined 5-FU and the chiral mixture of d,l-FA. Efficacy was within the range of that observed with the 5-FU d,l-FA combination, although at the lower level.

Original languageEnglish
Pages (from-to)338-343
Number of pages6
JournalEuropean Journal of Cancer
Volume30
Issue number3
DOIs
Publication statusPublished - 1994

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

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    Rosso, R., Mazzei, T., Sobrero, A., Mini, E., Cartei, G., Conte, P., Labianca, R., Cartei, F., Falcone, A., Pancera, G., Barsanti, G., Di Costanzo, F., Guglielmi, A., Bolli, E., Tixi, L., Aschele, C., Ribecco, A., & Periti, P. (1994). Phase II trial of 5-fluorouracil and the natural l isomer of folinic acid in the treatment of advanced colorectal carcinoma. European Journal of Cancer, 30(3), 338-343. https://doi.org/10.1016/0959-8049(94)90253-4