DAILY ORAL ETOPOSIDE IN PATIENTS WITH HEAVILY PRETREATED METASTATIC BREAST-CANCER

The objective of this phase II study was to evaluate the activity and toxicity of oral etoposide (50 mg/m(2) daily for 21 days in 28-day cyc les) in patients with heavily pretreated metastatic breast cancer. Thi rty patients were entered into the study; all had clinical or radiolog ic evidence of disease progression, median age was 51 years, and the m ajority of patients (82%) had a Zubrod performance status equal to or lower than 1 and a median of 3 disease sites. All patients had receive d chemotherapy, and more than 80% had received 3 or more regimens. Mor e than 70% of the patients had received taxanes as one of their previo us therapies. Twenty-four and 28 patients were evaluable for tumor res ponse and toxicity, respectively. One partial response was seen (<4%), and seven patients (25%) demonstrated stable disease with a median du ration of four months. There was significant hematologic toxicity. In two patients therapy had to be stopped because of excessive toxicity, and five patients required hospitalization for neutropenic fever. Over all, 57% of patients experienced grade 2 or higher degree of neutropen ia including two patients with grade 3 toxicity. Seventeen percent of patients developed grade 2 or greater thrombocytopenia, including one patient who experienced grade 4 toxicity, and 71% of the patients had grade 2 or more severe anemia including two patients with grade 4 toxi city. Oral etoposide has limited activity as third- or fourth-line age nt and produces significant hematologic toxicity in patients with heav ily pretreated metastatic boast cancer.