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Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer
Date:12/14/2008

n Cancer Center and Professor of Medicine & Women's Health at the Albert Einstein College of Medicine in New York, and lead investigator on the study. "The study suggests that the combination of DOXIL and docetaxel may be an effective treatment for patients with metastatic breast cancer who have relapsed after prior adjuvant anthracycline therapy."

Study Background

The study enrolled 751 women in 19 countries. Patients were randomly assigned to one of two treatment arms: DOXIL 30 mg/m2 followed by docetaxel 60 mg/m2 on the first day of every 21-day cycle; or docetaxel 75 mg/m2 on the first day of every 21-day cycle. Treatment continued until an unacceptable treatment-related toxicity or disease progression occurred.

The primary endpoint of the study was time to progression, as determined by independent reviewers blinded to study treatment. Secondary endpoints included response rate, overall survival and safety.

Response rates (the percentage of patients whose cancer shrinks after treatment) in patients treated with the DOXIL and docetaxel combination were significantly higher than those treated with docetaxel monotherapy (35% versus 26% respectively; p= 0.0085). Overall survival data were not yet mature; a final protocol-specified survival analysis is planned after the occurrence of 485 events.

The most common adverse reactions (e.g., those occurring in at least 20% of the patients) for the DOXIL and docetaxel combination compared to the monotherapy group, respectively, were:

     * Hematological toxicities and infections, including:
         - Neutropenia - 66% (Grade 3/4 57%) versus 65% (Grade 3/4 59%), with
           febrile neutropenia reported in 7% versus 6% of patients
         - Anemia - 20% (Grade 3/4 2%) versus 17% (Grade 3/4 1%)
         - Infection - 30% (Grade 3/4 5%) versus 25% (Grade 3/4 2%)
     * Hand-foot syndrome:  61% (Grade 3/4 24%
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SOURCE Ortho Biotech Products, L.P.
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