Uracil-tegafur (UFT) geeft zelfde resultaat bij uitgezaaide darmkanker als intraveneuze chemo (5-FU en leucovorin) maar veel minder bijwerkingen en veel gemakkelijker in te nemen

d.d. 25 april 2004: Bron: Pubmed, J Clin Oncol. 2002 Sep 1;20(17):3605-16

. Onderstaande dubbelblinde gerandomiseerde studie suggereert en bewijst dat Uracil-tagafur (UFT) in vergelijking met 5-FU en leucorin een even goed resultaat geeft bij uitgezaaide darmkanker maar met veel minder bijwerkingen en veel gemakkelijker in te nemen. Wie op internet zoekt ziet dat deze oral chemo in tabletvorm net als Xeloda bv. bij veel verschillende vaste tumoren nu wordt uitgeprobeerd in fase II en fase III trials. Een interessante ontwikkeling.

Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer.

Douillard JY, Hoff PM, Skillings JR, Eisenberg P, Davidson N, Harper P, Vincent MD, Lembersky BC, Thompson S, Maniero A, Benner SE.

Centre Rene Gauducheau, Nantes, France. jy-douillard@nantes.fnclcc.fr PURPOSE: This phase III study was designed to demonstrate equivalence in survival of oral uracil/tegafur (UFT) and oral leucovorin (LV) to conventional intravenous (IV) fluorouracil (5-FU) and LV in previously untreated metastatic colorectal carcinoma. Safety was also compared.

PATIENTS AND METHODS: Eight hundred sixteen patients were randomized to receive either UFT (300 mg/m(2)/d) and LV (75 or 90 mg/d) for 28 days every 35 days or IV bolus 5-FU (425 mg/m(2)/d) and LV (20 mg/m(2)/d) for 5 days every 28 days.

RESULTS: UFT/LV produced survival comparable to the IV 5-FU/LV regimen. Median survival was 12.4 months (95% confidence interval , 11.2 to 13.6 months) with UFT/LV and 13.4 months (95% CI, 11.6 to 15.4 months) with 5-FU/LV (P =.630). The hazard ratio for survival was 0.964 (95.6% CI, 0.826 to 1.125), supporting equivalent survival. The overall response rate did not differ between treatment arms (UFT/LV, 11.7%; 5-FU/LV, 14.5%; P =.232). Median time to progression favored 5-FU/LV (UFT/LV, 3.5 months; 5-FU/LV, 3.8 months; P =.011), but tumor assessment schedules differed between arms. UFT/LV significantly improved safety compared with 5-FU/LV. Diarrhea, nausea and vomiting, and stomatitis and mucositis were significantly less frequent with UFT/LV, as was myelosuppression. Patients treated with UFT/LV had fewer episodes of febrile neutropenia (P <.001) and documented infections (P <.05). Increased bilirubin, without other liver function abnormalities, was observed more often with UFT/LV (P <.001). Concomitant medications were more frequent with 5-FU/LV, including use of antibiotics, growth factors, and antiemetics.

CONCLUSION: UFT/LV provided a safer, more convenient oral alternative to a standard bolus IV 5-FU/LV regimen for metastatic colorectal cancer while producing equivalent survival.

 


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