[Phase II study of epirubicin in inoperable or recurrent gastric cancer]

A phase II clinical trial of epirubicin, a new anthracycline anticancer antibiotic, was carried out in 41 patients with inoperable or recurrent gastric cancer. Epirubicin was administered by i.v. injection; the dosages were either 40-60 mg/m2 every three weeks (Regimen A) or 20-30 mg/m2/day for 3 days every three weeks (Regimen B). Twenty-one patients were entered into Regimen A, and 20 into Regimen B. Of 31 evaluable patients, 16% (5/31) experienced objective response (PR); i.e., 20% (three of 15) treated with Regimen A and 13% (two of 16) with Regimen B, showing that there was no significant difference in the rate of response between the two regimens. Adverse effects observed were relatively mild in most cases and included anemia, leukopenia, thrombocytopenia, anorexia, nausea/vomiting, diarrhea, stomatitis and alopecia. Tachycardia and extrasystole were observed in 3 cases but disappeared upon discontinuation of the treatment. In conclusion, epirubicin seemed to have therapeutic activity comparable to that of doxorubicin in gastric cancer while being less toxic than doxorubicin, and is expected to become a better alternative to the latter drug.