Phase I/II study of gemcitabine with pegylated liposomal doxorubicin as first-line therapy in Asian women with metastatic breast cancer

This was a single institution phase I/II study to determine the maximum tolerated dose (MTD) and efficacy of pegylated liposomal doxorubicin (PLD) and gemcitabine in Asian women with metastatic breast cancer. PLD was administered on day 1 and gemcitabine on days 1 and 8 every 3 weeks at escalating doses from 25 mg/m(2) and 1000 mg/m(2) onwards respectively. The median age was 56 years with a median disease-free interval of 43 months. Majority of the patients had visceral involvement. At PLD 35 mg/m(2) and gemcitabine 1200 mg/m(2), the overall response rate for 23 evaluable patients was 83% (1 CR, 18 PR, 3 SD, 1 PD). Six had prior adjuvant anthracyclines (3 PR, 1 SD). The median follow-up was 8 1 weeks and progression free interval was 29 weeks. Overall survival was 23.9 months. The dose limiting toxicities were mucositis and myelosuppression. This regimen is active and reasonably tolerated as first-line therapy. (C) 2008 Elsevier Ltd. All rights reserved.