754 5-FU/FA IV bolus therapy vs weekly high-dose 5-FU/FA 24-hour infusion in metastatic colorectal carcinoma: Preliminary results of an ongoing randomized phase III study

Since January 1993 we are conducting a randomized phase III study in pts with metastatic colorectal carcinoma comparing 5-FU (425 mg/m 2 )/FA (20 mg/m 2 ) days 1–5 as iv bolus therapy given every 4 weeks (arm A) with weekly high-dose 5-FU (2600 mg/m 2 ) 24-hour infusion (arm B). So far, 37 pts in each arm are evaluable for response and toxicity. Pts in both arms are comparable with regard to sex, age, performance status, localizationof metastates and number of metastatic sites. Preliminary response rates are: PR 22% (A) and 27% (B), SD 32% (A) and 5l% (B), PD 46% (A) and 22% (B). Probability of median survival is 12 (A) and 15 (B) months, respectively. Moderate mucositis, diarrhea and nausea are the most frequent toxicities in both arms. Hematotoxicity is absent in arm B, but about one third of the pts develop reversible hand foot syndrome. Conclusion Although no statistically significant differences between the two treatment arms are seen so far, we believe that these preliminary results justify the continuation of the study.