EPIRUBICIN HAS MODEST SINGLE-AGENT ACTIVITY IN HEAD AND NECK-CANCER BUT LIMITED ACTIVITY IN METASTATIC MELANOMA AND COLORECTAL-CANCER - PHASE-II STUDIES BY THE EASTERN-COOPERATIVE-ONCOLOGY-GROUP

Epirubicin (4'-epidoxorubicin), a diastereoisomer of doxorubicin, has established activity in the treatment of many cancer types sensitive t o doxorubicin. Its activity in other tumor targets such as melanoma, h ead and neck cancer, and recurrent colorectal cancer has been less wel l defined. Three concurrent phase IT studies examined the efficacy and toxicity of epirubicin (90 mg/m(2) given intravenously at 3-week inte rvals) in the treatment of 71 patients with the aforementioned cancers . Of 66 eligible patients who were assessable for response, one patien t (with colorectal cancer) achieved a complete response and three pati ents (with head and neck cancer) achieved partial responses. The respo nse rate in patients with head and neck cancer was 18% (95% confidence interval, 4-43%). Myelosuppression, alopecia, and nausea were the mos t frequent toxicities. Two patients died of neutropenic sepsis and gra de IV leukopenia occurred in six patients (8%). Grade In toxicities we re as follows: leukopenia (17%), anemia (10%), alopecia (8%), fever (1 %), thrombocytopenia (1%). Grade I or II cardiac toxicity was noted in four patients at cumulative doses ranging between 375 mg/m(2) to 1,28 3 mg/m(2). Epirubicin is ineffective as a single agent at this dose an d schedule in the treatment of patients with melanoma and colorectal c ancer. In head and neck cancer, a modest response rate encourages furt her exploration of epirubicin and related anthracyclines in combinatio n regimens.