Prospective randomised trial comparing fluorouracil versus doxifluridine for the treatment of advanced colorectal cancer

A Prospective Randomized Trial Comparing Intravenous 5- Fluorouracil and Oral Doxifluridine As Postoperative Adjuvant Treatment for Advanced Rectal Cancer

“…Toxicity was acceptable in both arms, although grade III-IV neurological side effects and leukopenia were more common after doxifluridine (dFUR) infusion. Thereafter, Bajetta et al 3 reported that oral doxifluridine (1200/m 2 ) with oral leucovorin (25 mg) on days 1-5, with the cycle repeated every 10 days, was given in 108 patients with colorectal cancer. Their results showed good compliance with safety, but therapeutic efficacy seemed to be limited.…”

“…In metastatic colorectal cancer patients, doxifluridine with oral leucovorin has shown similar activity to intravenous regimen using 5-FU plus leucovorin. 3 If the oral doxifluridine regimen shows comparable results in therapeutic efficacy, oral doxifluridine can be recommended as far as quality of life and toxicities are concerned. The aim of this prospective randomized trial was to compare the therapeutic effect, toxicity, and quality of life between a standard intravenous 5-FU regimen and oral doxifluridine (5Ј-deoxy-5-fluorouridine, dFUR) in patients with locally advanced rectal cancer as postoperative adjuvant chemotherapy.…”

Randomized phase II noncomparative trial of oral and intravenous doxifluridine plus levo-leucovorin in untreated patients with advanced colorectal carcinoma

“…The response rates in the intent-to-treat population of all 130 patients were 15% in arm A (10 of 67; 95% confidence interval [CII,[7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] 44) and 39% of those treated intravenous (17 of 43) responded to treatment.…”

“…5-FU, the median time to progression was significantly longer in the 5-dFUR group. 13 The oral formulation of 5-dFUR, characterized by its high and reproducible bioavailability, has shown interesting antitumoral activity at an acceptable level of toxicity. The most common oral doses are 800 mgl m2/day for continuous administration or 1000-1600 mg/m2/day for intermittent administrati~n.'~.…”

Dose–Finding Study of 5&#8217;-Deoxy-5-Fluorouridine in Combination with Fixed Doses of Cisplatin and <i>L</i>-Folinic Acid for the Treatment of Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

“…x 5 days in good-or poor-risk patients, respectively, demonstrated that 5dFUR has def inite activity in a variety of tumors usually sensitive to fluoropyrimidines, such as carcinoma of the breast [20], colon-rectum [21 ], and of the head and neck district [22], Furthermore, some comparative trials with 5FU for 5 consecutive days were carried out in colorectal cancer [23,24], Also in these trials, the infusion time seemed to affect both type and severity of toxicity. Indeed, a higher occur rence of neurologic (48%) and cardiac toxicity (19%) as compared to the parent compound was reported when 5dFUR was administered as intravenous bolus [23], while these side effects affected 23 and 1% of patients, respec tively, when 5dFUR was given as 1-hour intravenous infusion [24], In advanced SCCHN, the combination of CDDP and continuous intravenous infusion 5FU, with or without the addition of L-FA, has demonstrated to be a very active treatment itself, for unresectable or recurrent disease [4][5][6][7][8]. Similar results were also obtained when 5FU was administered as intravenous bolus or short infusion in stead of a 5-day continuous infusion [9,10].…”