5-Fluorouracil (5-FU) continuous intravenous infusion compared with bolus administration. final results of a randomised trial in metastatic colorectal cancer
| Autor: | J.F. Seitz, Francois Morvan, C. Rekacewicz, Grandjouan S, Ph. Rougier, M. Luboinski, Agnès Laplanche, J. M. Tigaud, P. Laplaige, Bernard Paillot, M.C. Fabri, J.H. Jacob, Michel Ducreux |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Male
Antimetabolites Antineoplastic Cancer Research medicine.medical_specialty Randomization Colorectal cancer medicine.medical_treatment Gastroenterology Disease-Free Survival Bolus (medicine) Internal medicine medicine Humans Infusions Intravenous Survival rate Survival analysis Chemotherapy Performance status business.industry Middle Aged medicine.disease Survival Analysis Surgery Survival Rate Oncology Fluorouracil Female Colorectal Neoplasms business medicine.drug |
| Zdroj: | European Journal of Cancer. 33:1789-1793 |
| ISSN: | 0959-8049 |
| DOI: | 10.1016/s0959-8049(97)00175-5 |
| Popis: | The aim of this Phase III, balanced randomised trial was to compare continuous intravenous infusion (CVI) of 5-FU with bolus (B) administration for metastatic colorectal cancer (CRC). One hundred and fifty-five non-pretreated patients were randomised to receive CVI 5-FU at a dose of 750 mg/m2/day (d), 7 d every 21 d (n = 77), or bolus 5-FU 500 mg/m2/d x 5 d every 28 d (n = 78). Incremental dose escalation at 50 mg per step was recommended in the absence of toxicity. All the patients had measurable metastatic disease (M), particularly, liver and a good performance status (WHO grade 0-1). Dose intensity was significantly higher in CVI than in the bolus group: 1369 mg/m2/week versus 558 mg/m2/week (P = 0.0001). Grade II-IV stomatitis was more frequent in the CVI group (31% versus 9%; P < 0.0001) as was hand and foot syndrome (14% versus 3%; P < 0.001). Diarrhoea (22% versus 12%) and grade III granulocytopenia (2% versus 6%) were comparable. Responses were more frequent in the CVI (26%) than in the bolus group (13%) (P < 0.04); progression-free survival was higher for the CVI group (P = 0.04), but there was no statistical difference in overall survival (median: 10 months (m) compared to 9 m), and 1 year survival (SD) 42% (6%) versus 40% (6%). In the multivariate analysis, survival was better for patients with a good PS, well-differentiated adenocarcinomas and a primary tumour without serosal extension. In conclusion, with a higher dose intensity, CVI 5-FU improved tumour control, but not overall survival. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect