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Titolo:
Phase II study of a weekly 24-hour infusion with 5-fluorouracil and simultaneous sodium-folinic acid in the first-line treatment of metastatic colorectal cancer
Autore:
Hartung, G; Hofheinz, RD; Wein, A; Riedel, C; Rost, A; Fritze, D; Kreuser, ED; Drees, M; Kuhnel, J; Hehlmann, R; Queisser, W;
Indirizzi:
Univ Klinikum Rostock, Hamatol Onkol Abt, Klin & Poliklin Innere Med, D-18057 Rostock, Germany Univ Klinikum Rostock Rostock Germany D-18057 , D-18057 Rostock, Germany Univ Heidelberg, Onkol Zentrum, Med Klin 3, Univ Klinikum Mannheim, Mannheim, Germany Univ Heidelberg Mannheim Germany v Klinikum Mannheim, Mannheim, Germany Univ Erlangen Nurnberg, Med Klin 1, D-8520 Erlangen, Germany Univ ErlangenNurnberg Erlangen Germany D-8520 D-8520 Erlangen, Germany Klinikum Darmstadt, Med Klin 5, Darmstadt, Germany Klinikum Darmstadt Darmstadt Germany dt, Med Klin 5, Darmstadt, Germany Krankenhaus Barmherzigen Bruder, Med Klin, Regensburg, Germany KrankenhausBarmherzigen Bruder Regensburg Germany Regensburg, Germany Medac GMBH, Wedel, Germany Medac GMBH Wedel GermanyMedac GMBH, Wedel, Germany
Titolo Testata:
ONKOLOGIE
fascicolo: 5, volume: 24, anno: 2001,
pagine: 457 - 462
SICI:
0378-584X(200110)24:5<457:PISOAW>2.0.ZU;2-W
Fonte:
ISI
Lingua:
ENG
Soggetto:
HIGH-DOSE INFUSION; PRETREATED PATIENTS; MEDICAL ONCOLOGY; CARCINOMA; LEUCOVORIN; FLUOROURACIL; ASSOCIATION; THERAPY; SOCIETY; BOLUS;
Keywords:
colorectal cancer; phase II study; 5-fluorouracil; calcium-folinic acid; sodium-folinic acid; weekly 24-hour infusion;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
22
Recensione:
Indirizzi per estratti:
Indirizzo: Hartung, G Univ Klinikum Rostock, Hamatol Onkol Abt, Klin & Poliklin Innere Med, Ernst Heydemann Str 6, D-18057 Rostock, Germany Univ Klinikum Rostock Ernst Heydemann Str 6 Rostock Germany D-18057
Citazione:
G. Hartung et al., "Phase II study of a weekly 24-hour infusion with 5-fluorouracil and simultaneous sodium-folinic acid in the first-line treatment of metastatic colorectal cancer", ONKOLOGIE, 24(5), 2001, pp. 457-462

Abstract

Background. A weekly continuous 24-hour infusion therapy with 5-fluorouracil (5-FU) and calcium - folinic acid (CA-FA) was shown to be an effective first-line treatment in advanced metastatic colorectal cancer. Sodium - folinic acid (S-FA) is a new formulation which, in contrast to CA-FA allows thesimultaneous Lv. administration in combination with 5-FU in one pump. Patients and Methods; From 1997 to 1998, 51 patients [median age 60 (range 24-77) years; 38 male, 13 female] with metastatic colorectal cancer were recruited in 5 centers to receive weekly 24-hour infusions of 5-FU (2,600 mg/m(2)) and S-FA (500 mg/m(2)) dissolved in one pump for 6 weeks as first-line treatment. The treatment cycle was repeated after a 2-week rest period. Results: 1,178 administrations (median 24, range 3-54) were performed during thestudy. Out of 51 patients (median follow-up 20.2 months), 2 (3.9%) achieved complete remission (CR), 17 (33.3%) partial remission (PR), and 21 (41.2%) no change (NC). Progressive disease (PD) was observed in 11/51 (21.6%) patients, including 6 patients who did not complete the first cycle. Median time to tumor progression (TTP) was 8.5 months (95% Cl: 5.8-11.3). 32/51 (62.7%) patients survived for more than 1 year, the median survival was reached at 16.5 months (95%Cl: 10.2-22.8). Among major toxicities, NCL-CTC grade III/IV diarrhea occurred in 13/51 25.4%), grade III hand-foot syndrome in 6/51 (11.7% patients. Grade III/IV stomatitis was observed in 4/51 (7.8%), cardiac toxicity occurred in 2/51 patients (3.9%). Conclusion: Similar to conventional 24-hour 5-FU + CA-FA treatment, the combination with S-FA induced 37.2% objective responses with moderate toxicity. However, TTP seems favorable and the administration of S-FA is convenient, while saving costs and time for the patient in outpatient units.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/01/20 alle ore 10:44:44