Efficacy of Oral Etoposide in Pretreated Metastatic Breast Cancer

No standard chemotherapy has been defined for metastatic breast cancer (MBC) patients pretreated with anthracyclines and tax- anes. A multicenter phase 2 study was conducted to evaluate the safety and efficacy of oral etoposide in patients with MBC. Eligible patients were treated with repeated cycles of oral etoposide (60mg/m 2 /d on days 1-10, followed by 11 days of rest). The primary endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate, clinical benefit rate (CBR), and toxicity profiles. Seventy-five women with MBC were enrolled at 10 centers in China. Seven (9.3%) patients achieved partial response (PR) and 29 (38.7%) had stable disease (SD). Nine patients (12%) had SD for >24 weeksandtheCBRwas21.3%(16/75).ThemedianPFSwas4.5(range, 1.3-7.7) months. Of the 38 patients who received � 3 regimens prior to this study, 2 (5.3%) had PR and 3 (7.9%) had SD for >24 weeks, with a CBR of 13.2%. The reported grade 3/4 adverse events included leu- kopenia (13.3%, n ¼10), neutropenia (17.9%, n ¼14), anemia (2.7%, n ¼2), vomiting (2.6%, n ¼2), and alopecia (1.3%, n ¼1). Oral etoposide was effective and well tolerated in Chinese women with pretreated MBC.