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 language | English |
|---|---|
| Pages (from-to) | 338-343 |
| Number of pages | 6 |
| Journal | European Journal of Cancer |
| Volume | 30 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 1994 |
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ASJC Scopus subject areas
- Cancer Research
- Hematology
- Oncology
Cite this
Phase II trial of 5-fluorouracil and the natural l isomer of folinic acid in the treatment of advanced colorectal carcinoma. / 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.
In: European Journal of Cancer, Vol. 30, No. 3, 1994, p. 338-343.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase II trial of 5-fluorouracil and the natural l isomer of folinic acid in the treatment of advanced colorectal carcinoma
AU - Rosso, R.
AU - Mazzei, T.
AU - Sobrero, A.
AU - Mini, E.
AU - Cartei, G.
AU - Conte, P.
AU - Labianca, R.
AU - Cartei, F.
AU - Falcone, A.
AU - Pancera, G.
AU - Barsanti, G.
AU - Di Costanzo, F.
AU - Guglielmi, A.
AU - Bolli, E.
AU - Tixi, L.
AU - Aschele, C.
AU - Ribecco, A.
AU - Periti, P.
PY - 1994
Y1 - 1994
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0028241595&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0028241595&partnerID=8YFLogxK
U2 - 10.1016/0959-8049(94)90253-4
DO - 10.1016/0959-8049(94)90253-4
M3 - Article
VL - 30
SP - 338
EP - 343
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
IS - 3
ER -