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Titolo:
Phase I study of a weekly schedule of oxaliplatin, high-dose leucovorin, and infusional fluorouracil in pretreated patients with advanced colorectal cancer
Autore:
Rosati, G; Rossi, A; Tucci, A; Pizza, C; Manzione, L;
Indirizzi:
Osped S Carlo, UO Oncol Med, Potenza, Italy Osped S Carlo Potenza ItalyOsped S Carlo, UO Oncol Med, Potenza, Italy Osped Civile, UO Oncol Med, Nola, Na, Italy Osped Civile Nola Na ItalyOsped Civile, UO Oncol Med, Nola, Na, Italy
Titolo Testata:
ANNALS OF ONCOLOGY
fascicolo: 5, volume: 12, anno: 2001,
pagine: 669 - 674
SICI:
0923-7534(200105)12:5<669:PISOAW>2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Soggetto:
48-HOUR CONTINUOUS-INFUSION; WEEKLY 24-HOUR INFUSION; BIMONTHLY LEUCOVORIN; RANDOMIZED TRIAL; 5-FLUOROURACIL; CHEMOTHERAPY; THERAPY; MODULATION; REGIMEN; BOLUS;
Keywords:
5-fluorouracil; leucovorin; metastatic colorectal cancer; oxaliplatin;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
26
Recensione:
Indirizzi per estratti:
Indirizzo: Rosati, G Via Nazario Sauro 59, I-85028 Rionero In Vulture, Italy Via Nazario Sauro 59 Rionero In Vulture Italy I-85028 e, Italy
Citazione:
G. Rosati et al., "Phase I study of a weekly schedule of oxaliplatin, high-dose leucovorin, and infusional fluorouracil in pretreated patients with advanced colorectal cancer", ANN ONCOL, 12(5), 2001, pp. 669-674

Abstract

Purpose: To identify the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of oxaliplatin (L-OHP) given on a weekly schedule including fixed doses of leucovorin (LV) and infusional 5-fluorouracil (5-FU), to define the toxicity profile of this regimen and to find preliminary evidence of its activity in pretreated patients with metastatic colorectal cancer (MCRC). Patients and methods: Twenty-one patients with progressive disease, treated with fluoropyrimidines and with histologically measurable MCRC entered into this phase I study. Fixed doses of LV (500 mg/m(2)) followed by a 48-hour 5-FU 2600 mg/m(2) infusion (5-FU48h) were administered with escalating doses of L-OHP, starting from 60 mg/m(2) and with stepwise increments of 5 mg/m(2). No intra-patient dose escalation was allowed. Treatment was given once a week for four consecutive weeks, followed by a one-week rest period. Results: Three dose levels were tested. The MTD was L-OHP 70 mg/m(2) sincetwo of the three patients showed dose-limiting diarrhea and the third developed neutropenia during the first cycle of chemotherapy. Most patients complained of mild peripheral sensitive neurotoxicity, which was related to the cumulative dose of L-OHP. Treatment delays were necessary for a total of 42 cases, but only in 11 of 42 after the pre-arranged 10% dose reduction of5-FU (2300 mg/m(2)). Sixteen patients were evaluable for response: seven (33%; 95% confidence interval (CI): 14.6%-57.0%) were considered to show a major response (one complete), six showed a stable disease, and in addition progressive disease was observed in three patients. Conclusions: Our results show that L-OHP, LV and 5-FU can be administered safely and repetitively using a weekly schedule. Diarrhea and neutropenia are the DLT of this regimen. Its activity and its manageable toxicity profile deserve further evaluation in chemotherapy-naive MCRC patients. The dosesrecommended for phase II trials are: L-OHP 65 mg/m(2), LV 500 mg/m(2) and 5-FU48h 2300 mg/m(2) infusion given on a weekly-times-four schedule followed by a one-week rest period.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 23/01/20 alle ore 04:18:19