Francesco Giotta, MD, Director, Oncology Institute, Bari, Italy, gave a presentation on February 2^nd in which he discussed the findings of his study, in which his research team tested the effectiveness of liposome-encapsulated doxorubicin combined with cyclophosphamide in 57 women with untreated histologically or cytologically proven metastatic breast cancer.

Subjects received liposome-encapsulated doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m², both as a 1-hour IV infusion. Cycles were repeated every 3 weeks.

"Doxorubicin is the most commonly used anthracycline and is one of the most active single agents in breast cancer treatment," Dr. Giotta observed. "The risk of cardiomyopathy means that patients frequently have to stop treatment prematurely even though treatment is providing clinical benefit."

Several approaches have been used to reduce anthracycline-related cardiac toxicity, he explained. Liposome-encapsulated doxorubicin was developed to increase the amount of drug delivered to tumors and decrease the amount that reaches vital organs such as the heart.

In his study, Dr. Giotta and colleagues found that of 42 evaluable women, eight had complete responses and 20 had partial responses -- for an overall response rate of 67%. Nine patients had stable disease, and five had progressive disease.

Median duration of response was 10 months, and median survival thus far is 12+ months.

Grade I to II leukopenia occurred in 16 patients and Grade I to II anemia in 15 patients. Two patients developed Grade I thrombocytopenia.

Twelve patients had grade I to II nausea and vomiting and two had grade II mucositis.

One patient had a 20% decrease in ejection fraction but was asymptomatic.

"Our preliminary results thus show that the combination of liposome-encapsulated doxorubicin with cyclophosphamide is active and well tolerated with an acceptable toxicity profile," Dr. Giotta concluded. "These observations suggest that the regimen is suitable for administration on an outpatient basis."


[Presentation title: Liposome-Encapsulated Doxorubicin Plus Cyclophosphamide As First-Line Therapy in Metastatic Breast Cancer: A Phase II Study.]

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