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| |  SABCS: Caelyx (Doxorubicin Liposome Injection) Well Tolerated by Patients with Advanced Breast Cancer By Robert H. Carlson SAN ANTONIO, TX -- December 13, 2001 -- Monotherapy with Caelyx (doxorubicin liposome injection) is well tolerated as second-line treatment in patients with metastatic breast cancer, with a high rate of clinical benefit. Caelyx, known as Doxil in the United States, is the pegylated form of liposomal doxorubicin, which has shown activity in patients with pretreated metastatic breast cancer. During a poster presentation at the 24th Annual San Antonio Breast Cancer Symposium, in San Antonio, Texas, the researchers described their multi-center phase II study of Caelyx in women who had one palliative chemotherapeutic regimen excluding doxorubicin. Brigitte Mlineritsch, MD, an oncologist in the Outpatient Oncology Department, University of Salzburg, in Salzburg, Austria, said patients at study entry had to have progressive metastatic breast cancer with measurable or evaluable lesions, and adequate bone marrow, hepatic and renal functions. Since cardiotoxicity is a major concern with anthracycline therapy, left-ventricular ejection fraction had to be normal as determined by echocardiography at study entry and after six cycles of Caelyx treatment. Dr. Mlineritsch reported on the first 23 evaluable patients entered in the trial. Median age was 61 years (range 39-74) and 39 percent of patients had World Health Organization (WHO) performance status 1. More than 18 percent of patients had predominant visceral metastases. Treatment consisted of Caelyx 45 mg/mē four times weekly. Pretreatment for 26 percent of patients was with Navelbine (vinorelbine)-gemcitabine, 43 percent had Navelbine-fluorouracil-leucovorin, 4 percent had capecitabine, and 27 percent had cyclophosphamide-methotrexate-fluorouracil (CMF). Median number of cycles administered was five (range 1-8). Dr. Mlineritsch said toxicity was generally low, with the most common being grade 1 or 2 vomiting in 47 percent of women. Palmar-plantar erythrodysthesia (hand-foot syndrome) was experienced by 13 percent of patients, skin rash by 8 percent, alopecia by 8 percent and diarrhea by 4 percent. "Only one patient showed an acute infusion reaction, and cardiotoxicity was not seen at all," she said. Response rates so far have included 31 percent partial response (seven patients), and disease stabilization in another 54 percent, for a clinical benefit rate of 85 percent. Median time to progression was 28 weeks (range 5-132) and median duration of response was 28 weeks (range 19-33). "Median overall survival has not been reached," Dr. Mlineritsch concluded.
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