A phase II study of gemcitabine and liposomal doxorubicin (Lipo-Dox) as first line chemotherapy in the treatment of metastatic breast cancer

10688 Background: To determine the overall objective response rate (ORR) of Lipo-Dox plus Gemcitabine in patients with metastatic breast cancer. Patients and Methods: We are conducting an open-label, non-comparative phase II clinical trial in Simon’s 2-stage optimal design to assess the efficacy and the safety of the treatment with Gemcitabine (Gems) plus Liposomal Doxorubicin (Lipo-Dox) in patients with metastatic breast cancer. All eligible subjects received Lipo-Dox 25 mg/m2 intravenous infusion over 1 hr and follow by gemcitabine 800 mg/m2 intravenously (iv) over 30 minutes on day 1, and receive gemcitabine 800 mg/m2 intravenously (iv) over 30 minutes only on day 8 in a 21-day cycle. Results: Between July 2004 and December 2005, a total of 21 patients were enrolled in the study and total of 136 cycles of chemotherapy were delivered with a median of six per patients (range 1–16). 17 patients (80.8%) who had at least one post-treatment evaluation and exposed to at least two cycles of treatment were included in this report. Characteristics of the 17 patients: All females; median age 52 years (range 36 - 68); 16 pts had a performance status (PS) of 0 or 1 and 1 had a PS of 2 (ECOG scale); Histology: All metastatic breast cancer. The response assessment of the 17 patients: Complete response was observed in 2, partial response in 5, stable disease in 8, and progressive disease in 2 patients. Overall response rate was 41.17%. Major grade 3/4 hematological toxicities were neutropenia in 9 pts, thrombocytopenia in 2 pt and leukopenia in 5 pts. Peripheral neuropathy was noted in 1 patient (grade 2). Other toxicities occurred during the treatment cycles were all manageable or tolerable. Patient recruitment, treatment and follow-up are still ongoing. Conclusion: Liposomal Doxorubicin used in the regimen reduces the incidence of alopecia (hair loss) to grade 1 compare to the conventional doxorubicin. This study, with an overall response rate of 41.1% (CR+PR) and a rate of stable disease of 47.05%, has shown a good activity with mild and acceptable toxicities of Gemcitabine (Gems) plus Liposomal Doxorubicin (Lipo-Dox) regimen in patients with metastatic breast cancer. No significant financial relationships to disclose.