Gemcitabine and pegylated liposomal doxorubicin as salvage therapy in metastatic breast cancer (MBC)

Abstract

10645 Background: Doxorubicin and Taxanes are the most used drugs in front-line therapy for MBC. Patients with progressive disease refractory to these drugs are candidate to different salvage regimens. We investigated the combination of gemcitabine and pegylated liposomal doxorubicin as salvage option for these patients. Methods: This phase II study included gemcitabine (Gemzar) 1000 mg/m2 day 1, day 8 and pegylated liposomal doxorubicin (Caelyx) 25 mg/ m2 day 1 every 21 days. Inclusion criteria included measurable disease, performance status <2 according to the Zubrod scale, and no prior Gemzar or Caelyx treatment. Patients had to have one line of chemotherapy for metastatic disease. Responses were evaluated according to the RECIST criteria. Study Objectives were response rate, time to progression, and toxicity profile. Results: Between March 2003 and September 2005, 30 patients were enrolled. Mean age was 54 years [32–72]. 22 patients had two or more metastatic sites. Mean metastatic sites were liver (17), bone (12), lung (10) and pleura (5). 26 patients have had prior taxane treatment, and 21 prior anthracyclines. 144 cycles were delivered with a median of 6 per patient. There were 13 partial response, 11 stable disease, 5 progression and 1 unknown. Overall response rate was 43% with median response duration of 7 months (4–20+). 12 among the 13 objective responses were noted at visceral sites. During follow-up, 14 patients died. Median Survival time was 7 months. Median Time to progression was 7 months [0.5–20+]. The most encountered grade 3 or 4 toxicities were anemia in 5 pts, thrombopenia in one pt, neutropenia in 7 pts, neutropenic fever in 2 pts, hand-foot syndrome in 4 pts and stomatitis in 3 pts. No cardiotoxicity was noted. Conclusion: Salvage therapy for MBC could be successfully achieved by the combination of Gemcitabine and Pegylated liposomal doxorubicin (43% OR) according to our schedule. The tolerability was also acceptable. This schedule warrants further investigation. No significant financial relationships to disclose.