Phase II study of epirubicin sequential methotrexate and 5-fluorouracil for advanced colorectal cancer

91 patients with measurable metastatic colorectal carcinoma entered a phase II study. A three-drug schedule; epirubicin (20 mg/m2), sequential methotrexate (150 mg/m2), 5-fluorouracil (600 mg/m2) with 1-h interval (EMF) with folinic acid rescue was given weekly three times followed by 2-3 weeks rest. 85 patients were evaluable for response. 5 patients (6%) experienced a complete response (CR), 20 (23%) a partial response (PR), 31 (37%) had disease stabilisation (SD) and 29 (34%) progressive disease (PD). The median survival time was 13.7 months in all patients (n = 91) and 14.0 months in those evaluable for response (n = 85). In patients with CR, PR, SD and PD the median survival time was 46.7, 19.8, 14.7 and 8.7 months, respectively. The response rate was significantly (P < 0.05) higher in tumours originating from the colon (41%) than in those originating from the rectum (18%) and also significantly (P < 0.001) higher in non-symptomatic than in symptomatic patients, 40 vs. 4%, respectively. The treatment was fairly well tolerated as an outpatient regimen, the main dose-limiting side-effect being diarrhoea. Deaths for septic fever, which may be attributable to the treatment were encountered in 3 patients, all with progressive cancer. Further studies to disclose differences in response rate in subsets of patients are warranted.