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Combination Pegylated Liposomal Doxorubicin/ Gemcitabine Is Effective, Safe For Metastatic Breast Cancer

For patients with metastatic breast cancer, combination pegylated liposomal doxorubicin and gemcitabine provides an effective and safe therapeutic option for first-line treatment, reports a phase II study by researchers in Texas.

Although doxorubicin is a widely used anticancer drug used for several types of cancers, its associated toxicities make it less than optimal in the treatment of metastatic breast cancer in which improved quality of life is an important goal. Pegylated liposomal doxorubicin, however, is a new form of this drug that permits more targeted delivery of doxorubicin to tumour cells.

Based on encouraging phase I results that showed a good safety profile of combination pegylated liposomal doxorubicin and gemcitabine in metastatic breast cancer, Edgardo Rivera, MD and colleagues from The University of Texas MD Anderson Cancer Center, Texas conducted a phase II clinical trial to evaluate the efficacy of this regimen in 49 women with metastatic breast cancer who enrolled in the study from November 2000 and November 2001. Prior treatment included adjuvant chemotherapy in 27 (55%) of patients (single agent anthracycline in 8, combined anthracycline and taxane in 11, and cyclophosphamide/methotrexate/fluorouracil in 8), hormonal therapy in 21 (42.9%), and radiation therapy in 25 (51%).

Of the 49 patients, 46 were available for evaluation. The objective response rate in these patients was 52%, with a complete response in 6% and partial response in 46% of patients. Stable disease was evident in 26% of patients, and progressive disease in 22%. Median survival was 16.1 months, with a median response duration of 5.6 months and median time to progression of 4.5 months.

After a total of 310 cycles of treatment (median of 6 cycles per patient), grade 3 or 4 haematologic toxicities (granulocytopenia, thrombocytopenia, and anemia) and grade 3 or 4 nonhematologic toxicities (nausea, vomiting, fatigue, stomatitis, and hand-foot syndrome) were the most common toxicities reported. Cardiac toxicity was noted in 1 patient previously treated with an anthracycline, who experienced a 21% transient decrease in the left ventricular ejection fraction.

The authors conclude that combination pegylated liposomal doxorubicin and gemcitabine is an effective and safe treatment for women with metastatic breast cancer, and may be beneficial as both front-line therapy as well as therapy in patients who fail previous treatments for their metastatic disease.
J Clin Oncol 2003;21:3249-3254. "Phase II Study of Pegylated Liposomal Doxorubicin in Combination With Gemcitabine in Patients With Metastatic Breast Cancer"

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