Phase II study of esorubicin (4'-deoxydoxorubicin) in locally advanced or metastatic head and neck carcinoma.

Sixteen patients with locally advanced or metastatic head and neck cancer were treated with esorubicin (4'-deoxydoxorubicin) at a dose of 30-35 mg/m2 i.v. every 3 weeks. One patient was lost to the follow up after one cycle, whereas in the 15 evaluable cases a total of 34 courses were administered (median per patient: 2, range: 1-6). Pretreatment for parameter lesions consisted of radiotherapy in 5, chemotherapy in 3 and both treatments in 1 patients respectively. Overall, one partial response, one stable disease and 13 progressions were documented. Severe (grade 3 and 4) leukopenia, thrombocytopenia and anemia were noted in 3, 1 and 1 patients respectively. The only patient developing leukopenia and thrombocytopenia of grade 4 subsequently died because of pneumonia. On the other hand, non-hematologic toxicity was generally mild. At this dose and schedule, esorubicin demonstrated an activity less than 20% in head and neck cancer and therefore, no further evaluation is warranted.