Combination 5-fluorouracil (FU), folinic acid (FA), and alpha-interferon 2B in advanced XXXX : results of a phase II trial.

@entity1 @entity137 @entity390 @entity5 @entity294 @entity1003 @entity1820 @entity3 @entity158 @entity236 @entity356
BACKGROUND: Based on encouraging treatment results with FU/FA or FU/IFN in @entity1820 , a phase II study was conducted to evaluate the effects and @entity137 of combination FU/FA/IFN in @entity1 (pts) with inoperable/metastatic @entity356 . @entity1 AND METHODS: IFN 6 M.U. s.c. 1 x/week, FU 500 mg/m2 bolus i.v. 1 x/week and FA 500 mg/m2 1 x/week as a 2-hour infusion. Of 72 treated pts, 72 (22 females, 50 males) are evaluable for response and @entity137 . Median age was 55.6 years (28-80), and median Karnofsky performance status was 80% (70-100). Sites of measurable disease were inoperable primary @entity5 /local recurrence (18), liver @entity3 (22), lymph nodes (31) and peritoneum (20). One pt had @entity236 and another had paraneoplastic @entity1003 . RESULTS: 10/72 pts had complete response, 20/72 pts partial response, 40/72 pts @entity5 stabilization and 2/72 pts progressive disease. The median duration of response (CR/PR) was 9 months, the median progression-free interval 6 months, the median survival time was 9 months, and for responding @entity1 (CR/PR) 12.5 months. @entity137 : 1/72 pts had WHO grade 4 @entity137 ( @entity294 ), 5/72 pts had WHO grade 3 @entity137 ( @entity390 1, @entity294 4). Except for 1 treatment-limiting grade 4 @entity137 , no modifications of dose or schedule due to @entity137 were required. Thirty-six of 44 pts experienced a significant @entity158 under treatment. CONCLUSION: Biochemical modulation of FU with FA and IFN is effective in advanced @entity356 . Moderate @entity137 , outpatient treatment setting and high rates of amelioration @entity5 -related @entity158 contribute to an effective palliation.
