5-Fluorouracil versus 5-fluorouracil plus α-interferon as treatment of metastatic colorectal carcinoma. A randomized study

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Abstract
In 1989, S. Wadler reported very promising results (76% response rate) with a combination of 5-fluorouracil (5-FU) plus α-2a interferon (IFN) in the treatment of metastatic colorectal carcinoma (MCRC). in vitro, there are several potential explanations for synergism between the two agents. We therefore decided in 1989 to start a randomized study comparing 5-FU alone with 5-FU plus IFN. 105 non-pretreated patients with measurable metastatic colorectal carcinoma entered into this study. The patients were randomly allocated either in arm A (n = 49) with 5-FU: 750 mg/m2 i.v. CI d1-d5 followed by 750 mg/m2 iv. bolus once a week, or in arm B (n = 56) with 5-FU as in arm A plus IFN 9 × 106 IU sub-cutaneously three times a week. After two months of treatment we observed 1 CR and 2 PR in arm A (response rate 6.1%), 3 CR and 8 PR in arm B (response rate 19.6%), i.e., a significant difference (P =0.05). Event-free survival was significantly higher in arm B (6 months) than in arm A (2 months) (P P P = 0.13). Toxicity was also greater in arm B. Sixteen percent of patients in arm A and 36% in arm B experienced certain grade 3–4 side effects (P <0.05). 5-FU plus IFN is more effective than 5-FU alone in terms of response rate, event free survival but not of overall survival. 5-FU plus IFN is more toxic. As IFN has no demonstrated efficacy in MCRC as a single agent, this study suggests that IFN is acting as a 5-FU modulatory agent. The response rate observed (19.6%) is similar to the results obtained elsewhere with 5-FU plus leucovorin.

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