5-FLUOROURACIL AND INTERFERON-ALPHA-2A IN ADVANCED COLORECTAL-CANCER - RESULTS OF 2 TREATMENT SCHEDULES

Citation
Wj. John et al., 5-FLUOROURACIL AND INTERFERON-ALPHA-2A IN ADVANCED COLORECTAL-CANCER - RESULTS OF 2 TREATMENT SCHEDULES, Cancer, 72(11), 1993, pp. 3191-3195
Citations number
13
Categorie Soggetti
Oncology
Journal title
CancerACNP
ISSN journal
0008543X
Volume
72
Issue
11
Year of publication
1993
Pages
3191 - 3195
Database
ISI
SICI code
0008-543X(1993)72:11<3191:5AIIAC>2.0.ZU;2-A
Abstract
Background. Potential synergy between 5-fluorouracil (5-FU) and interf eron alpha-2a (IFN-alpha-2a) has been demonstrated in the treatment of colorectal carcinoma. Continuous low-dose infusion of 5-FU may have s uperior response rates to bolus 5-FU in these malignancies. This repor t presents results of two Phase II trials using these principles in co lorectal cancer. Methods. Forty-eight patients were entered onto two p rotocols; 18 were treated with 5-FU by a bolus infusion schedule with concurrent IFN-alpha-2a (Group 1). Thirty patients were treated with c ontinuous low-dose 5-FU and IFN-alpha-2a thrice weekly (Group 2). Resu lts. The overall response rates were 33% (95% confidence interval [CI] , 16-68%) and 33% (95% CI, 17-53%), respectively, for Groups 1 and 2. In Group 2, in 16 previously untreated patients, there was a response rate of 56% (95% CI, 30-80%). The median survival was 11 months and 6 months for Groups 1 and 2, respectively. Toxicity in Group 1 was as ex pected, except the incidence of central nervous system toxicity was lo w, with only one patient requiring dose reduction because of cerebella r ataxia. The toxicity in Group 2 was substantial, with four patients being removed from study because of toxicity and all patients treated for more than 2 months requiring dose reductions. The most common (67% ) toxicity was mucositis, with 33% of those patients classified as Gra de III or IV (Southwest Oncology Group criteria). Other major toxiciti es were fatigue and hand/foot syndrome. Conclusions. The first trial c onfirms previous response rate data for bolus injection 5-FU and IFN-a lpha-2a. The second trial of low-dose continuous infusion 5-FU with IF N-alpha-2a demonstrates similar efficacy with substantially greater to xicity.