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Titolo:
5-fluorouracil administered as a 48-hour chronomodulated infusion in combination with leucovorin and cisplatin: A randomized phase II study in metastatic colorectal cancer
Autore:
Falcone, A; Allegrini, G; Masi, G; Lencioni, M; Pfanner, E; Brunetti, I; Danesi, R; Bocci, G; Del Tacca, M; Conte, P;
Indirizzi:
Presidio Osped Livorno, UO Oncol Med, I-57121 Livorno, Italy Presidio Osped Livorno Livorno Italy I-57121 Med, I-57121 Livorno, Italy Osped S Chiara, UO Oncol Med, Pisa, Italy Osped S Chiara Pisa ItalyOsped S Chiara, UO Oncol Med, Pisa, Italy Univ Pisa, Dipartimento Oncol, Div Farmacol Chemioterapia, Pisa, Italy Univ Pisa Pisa Italy nto Oncol, Div Farmacol Chemioterapia, Pisa, Italy
Titolo Testata:
ONCOLOGY
fascicolo: 1, volume: 61, anno: 2001,
pagine: 28 - 35
SICI:
0030-2414(2001)61:1<28:5AAA4C>2.0.ZU;2-R
Fonte:
ISI
Lingua:
ENG
Soggetto:
PERFORMANCE LIQUID-CHROMATOGRAPHY; PLUS CONTINUOUS-INFUSION; WEEKLY 24-HOUR INFUSION; FOLINIC ACID; FLUOROURACIL; OXALIPLATIN; CARCINOMA; TRIAL; BOLUS; PLASMA;
Keywords:
chronoinfusion; 5-fluorouracil; cisplatin; randomized study; colorectal cancer;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
37
Recensione:
Indirizzi per estratti:
Indirizzo: Falcone, A Presidio Osped Livorno, UO Oncol Med, Viale Alfieri 36, I-57121Livorno, Italy Presidio Osped Livorno Viale Alfieri 36 Livorno Italy I-57121
Citazione:
A. Falcone et al., "5-fluorouracil administered as a 48-hour chronomodulated infusion in combination with leucovorin and cisplatin: A randomized phase II study in metastatic colorectal cancer", ONCOL-BASEL, 61(1), 2001, pp. 28-35

Abstract

Objective: The primary objective of this trial was to determine the objective response of two regimens with CDDP administered every 2 weeks immediately before or after an 'optimal' 48-hour chronomodulated infusion of 5-fluorouracil (5-FU) modulated with leucovorin (LV) in metastatic colorectal cancer patients. Secondary endpoints were toxicity, 5-FU and its metabolites, plasma pharmacokinetics and progression-free and overall survival. Methods: Metastatic colorectal cancer patients with measurable disease who were chemotherapy-naive or pretreated only with a 5-FU-bolus-based chemotherapy wereeligible for this study. The study was designed as a randomized phase II clinical trial. Results: Eighty-three patients were entered into the study. Forty-two were randomized to CDDP given before 5-FU and 41 to CDDP given after 5-FU. Patient characteristics were similar among the two groups. Toxicities were also similar among the two arms and the most frequent WHO grade III-IV toxicities were stomatitis (14%) and neutropenia (39-50%). Plasma pharmacokinetic profiles of 5-FU and 5-FUH2 were not significantly affected bythe sequence of CDDP and 5-FU administration. Antitumor activity was similar in the two arms and was very promising both in pretreated patients (response rate 29%; 95% confidence interval 15-46%) and in chemotherapy-naive patients (response rate 56%, complete response 9%, 95% confidence interval 40-71%). Median survival of the patients with and without pretreatment was 12and 16 months, respectively. Conclusions: These results do not suggest a sequence dependence of the synergism between CDDP and 5-FU. However, they challenge the need of oxaliplatin to improve 5-FU/LV activity in advanced colorectal cancer. In fact, our results with an 'optimal' 5-FU dose and scheduling are very similar to those obtained with oxaliplatin plus 5-FU/LV. However, only a randomized phase III study will be able to give an answer to the hypotheses raised by this study. Copyright (C) 2001 S, Karger AG, Basel.

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Documento generato il 22/01/20 alle ore 06:22:55