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Researchers from The West Clinic, the Mid-South's premier provider of interdisciplinary cancer care, and ACORN (Accelerated Community Oncology Research Network) today announced results from a Phase II study evaluating nanoparticle albumin bound (nab(TM)) -paclitaxel (ABRAXANE(R)) with capecitabine (Xeloda(R)) in a novel first-line combination treatment for patients with metastatic breast cancer at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO). The study demonstrated that nab-paclitaxel in combination with capecitabine resulted in a 61 percent overall tumor response rate and was well tolerated.
"Both therapies have shown substantial single-agent activity for the treatment of metastatic breast cancer," said Principal Investigator Lee S. Schwartzberg, M.D., The West Clinic. "The results of the study demonstrate that nab-paclitaxel and capecitabine, in combination, are very active and well tolerated as a first-line treatment suggesting a need for further comparative research of this novel combination."
Final results from the study "Phase II trial of nab(TM)-paclitaxel nanoparticle albumin-bound paclitaxel + capecitabine in first line treatment of metastatic breast cancer" (Abstract 1053) were presented in a poster by lead author Bradley G. Somer M.D. of The West Clinic. The multicenter, open label single-arm study of 50 patients was designed to evaluate the safety and efficacy of nab-paclitaxel with capecitabine in a novel dosing regimen for the first-line treatment of metastatic breast cancer. The primary endpoint of the study was tumor response rate, with an evaluation performed after every 2 cycles.
Patients were administered nab-paclitaxel 125 mg/m2 intravenously on day 1, 8 and with no premedication and capecitabine 825 mg/m2 prescribed orally twice a day, on days 1-14 on an every three week cycle. This novel combination demonstrated a 57 percent (n=26) partial response and 4 percent complete response (n=2), with a median progression free survival of 270 days in an evaluable population of 46 enrolled patients. Four patients were inevaluable due to adverse events (n=3) and brain metastases (n=1).
Most frequently reported Grade 3-4 adverse events included fatigue (n=4), hand foot syndrome (n=3), mucositis (n=3), nausea/vomiting (n=2), febrile neutropenia (n=2) and neutropenia (n=1). Dose reductions and delays were uncommon.
This research was supported by Abraxis BioScience, Inc. and Roche.
About Breast Cancer
According to the American Cancer Society, breast cancer is the most common cancer among women, other than skin cancer, and is the second leading cause of cancer death in women in the United States. The risk of having breast cancer for a woman sometime during her life is about one in eight. In 2007 alone, an estimated 178,480 new cases of breast cancer are expected to occur in women, and an estimated 40,460 women are expected to die from the disease.
About The West Clinic
The West Clinic is the Mid-South's premier provider of interdisciplinary cancer care with specialty providers in medical oncology, hematology, gynecologic oncology, diagnostic radiology, interventional radiology, endocrinology, rheumatology, pain & palliative care, internal medicine, and psychology throughout clinics located in Memphis, the Mid-South, and North Mississippi.
Accelerated Community Oncology Research Network, Inc. (ACORN)
The ACORN network includes over 30 progressive community oncology practices located throughout the U.S. and in Singapore. This collaboration of select community oncology clinics provides patients with access to the most promising clinical trials available anywhere. By employing the ACORN centralized model of efficiency and advanced technology, ACORN network members enjoy the advantage of a quicker and more efficient research process. By linking like-minded practices in a cooperative network, ACORN consistently meets accrual objectives and delivers quality data collection.
Lee Schwartzberg, M.D., F.A.C.P.
Dr. Lee Schwartzberg is a senior partner and Medical Director at The West Clinic in Memphis, Tennessee. He did a residency in Internal Medicine at Cornell University and fellowship training in Hematology and Oncology at Memorial Sloan-Kettering Cancer Center where he was chief resident in Medicine.
Dr. Schwartzberg is board certified in Internal Medicine, Medical Oncology and Hematology. He is a Clinical Professor of Medicine at The University of Tennessee College of Medicine. Dr. Schwartzberg serves as the Medical Director of the Baptist Centers for Cancer Care Stem Cell Transplant Program and Cancer Genetics Program at Baptist Memphis Hospital. He is President of the Accelerated Community Oncology Research Network (ACORN) and Chief Medical Officer of Supportive Oncology Services (SOS).
Dr. Schwartzberg has published numerous papers in peer-reviewed publications and has lectured extensively throughout the United States and internationally. He also serves as Editor-in-Chief of the journal Community Oncology. Dr. Schwartzberg serves as a committee member on the Institute of Medicine's (IOM) Committee on Psychosocial Services to Cancer Patients/Families.
Bradley G. Somer, M.D.
Dr. Brad Somer is a board certified Medical Oncologist with The West Clinic. Dr. Somer obtained his medical degree from the Albert Einstein College of Medicine with a "Distinction in Research". He completed his fellowship training at the University of Pennsylvania Cancer Center and internship and residency at the Hospital University of Pennsylvania in Philadelphia. Dr. Somer leads the clinical guideline process of The West Clinic and is actively involved in research as principal investigator of several research trials at The West Clinic and the Accelerated Community Oncology Research Network (ACORN).
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