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/m2 and 1000 mg/m2 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/m2 and gemcitabine 1200 mg/m2, 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 81 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.