Author/Editor		Štabuc, Borut; Markovič, Aleksandra; Brecelj, Erik; Bešlija, Samir; Cizej, Tomaž-Edvard
Title		Phase II study of fluorouracil, leucovorin and interferon alpha-2a in patients with advanced colon cancer
Translated title		Zdravljenje bolnikov z metastatskim rakom širokega črevesa s fluorouracilom, levkovorinom in interferonom alfa-2a
Type		članek
Source		Radiol Oncol
Vol. and No.		Letnik 32, št. 4
Publication year		1998
Volume		str. 407-15
Language		eng
Abstract		Based on in viro studies that have demonstrated synergy between fluorouracil (5-FU) and leucovorin (LV) as well as between 5-FU and recombinant alpha-2a interferon (IFN) against colon cancer cell lines a phase II study was carried out to evaluate the toxicity and clinical activity of 5-FU modulated with LV and IFN in patients with metastatic colon cancer. Twenty-two chemotherapy naive patients with measurable metastases of colon cancer have been treated with daily doses of 5-FU 600 mg/m2 in 6-hr intravenous infusion, and of LV 20 mg/m2 intravenously and IFN 6 MU subcutaneously, for 5 days every 4 weeks. Median age was 60 years, median PS (ECOG) was 1 (range 0-2). Liver, soft tissue and lung metastases were found in 12, 5 and 8 patients, respectively. Nineteen patients had a single metastatic site, two double, whereas one had more than two metastatic sites. Patients had 2-9 (mean 5) cycles of treatment. Objective response was observed in 7 patients (32%), and stable disease in 7 patients (32%). Overall median survival was 12.5 months, and for responders 14.4 months. Responses were generally short and median time for progression was 5.5 months. The most frequent adverse reactions were flu-like syndrome (50%), nausea/vomiting (36%), diarhoea (13Č), stomatitis (27%) and leucopenia (13%). This regimen of 5-FU with LV and IFN administration does not appear to be superior to previously published shedules of 5-FU with IFN or 5-FU with LV.
Summary		Predklinične raziskave so pokazale sinergistični protitumorski učinek fluorouracila (5-FU), levkorina (LV) ter 5-FU in rekombinantnega interferona alfa-2a (IFN). V II. fazi klinične raziskave smo želeli pri bolnikih z metastatskim rakom širokega črevesa ugotoviti toksičnost in učinkovitost zdravljenja s 5-FU, LV in IFN. V raziskavo smo vključili 22 bolnikov z merljivimi zasevki metastatskega raka širokega črevesa. 5-FU smo dajali v 6-urni intravenski infuziji v dnevnem odmerku 600 mg/m2, LV intravensko v dnevnem odmerku 20 mg/m2 in IFN podkožno v dnevnem odmerku 6 MIE. U_inkovine smo dajali 5 dni zapored vsake 4 tedne. Srednja starost bolnikov je bila 60 let. Srednje stanje zmogljivosti (ECOG) je bilo ocenjeno z 1 (rang 0-2). Dvanajst bolnikov je imelo zasevke v jetrih, 5 v mehkih tkivih in 8 v pljučih. Zasevke v enem organu je imelo 19 bolnikov, v dveh organih 2 bolnika in v 3 organih eden. Bolniki so imeli 2 in 9 ciklov zdravljenja, v povprečju 5 ciklov. Objektivni odgovor na zdravljenje smo ugotovili pri 7 bolnikih (32%), mirovanje bolezni pri 7 bolnikih (32%). Srednje preživetje je bilo 12,5 meseca, pri bolnikih, ki so odgovorili na zdravljenje pa 14,4 meseca. Odgovori na zdravljenje so bili kratkotrajni in so v povprečju trajali 5,5 meseca. Med neželenimi učinki zdravljenja smo gripozni uotovili pri 50%, slabost in bruhanje pri 36%, drisko pri 13%, stomatitis pri 27% in levkopenijo pri 13% bolnikov. Kombinirano zdravljenje s 5-FU, LV in IFN glede na rezultate dosedanjih kliničnih raziskav s 5-FU in LV ali 5-FU in IFN ni bolj učinkovit način zdravljenja.
Descriptors		COLONIC NEOPLASMS FLUOROURACIL LEUCOVORIN INTERFERON ALFA-2A CLINICAL TRIALS, PHASE II DRUG THERAPY, COMBINATION SURVIVAL ANALYSIS