Drug combo doubles progression-free survival for breast cancer patients with metastatic disease
SEATTLE – Adding the monoclonal antibody Avastin to Taxol when initially treating metastatic breast cancer doubled progression-free survival and response rates, but not overall survival, compared to treating patients with Taxol alone, according to a study to be published in the Dec. 26 edition of the New England Journal of Medicine. Julie Gralow, M.D., a medical oncologist at the Seattle Cancer Care Alliance, was a study co-investigator and paper co-author. Karen Miller, M.D., of Indiana University Cancer Center, is the paper’s lead author.
Avastin, known by its scientific name bevacizumab, already is FDA-approved for use in patients with colorectal and lung cancers, but is not yet approved for treating metastatic breast cancer. Taxol is the brand name for paclitaxel. While Taxol blocks cell division in tumors, Avastin blocks a tumor’s ability to grow the blood vessels needed to bring oxygen and nutrients to sustain the tumor.
“This study was the pivotal Phase 3 clinical trial that proves the effectiveness of this combination therapy for patients whose cancer has spread,” Gralow said. “This is another case for the use of biologically targeted therapies with a new category of agents that delay the progression of cancer.”
New clinical trials comparing an Avastin/chemotherapy combination to chemotherapy alone are expected to start enrollment after the new year to treat women with early-stage breast cancer that has not spread, or metastasized, to other parts of the body, according to Gralow, who is also an associate professor at the University of Washington School of Medicine and an associate member of the Clinical Research Division of Fred Hutchinson Cancer Research Center.
The randomized trial enrolled 722 patients between December 2001 and May 2004. The combination of paclitaxel and bevacizumab prolonged progression-free survival from 5.9 months to 11.8 months when compared to patients who received only paclitaxel. However, overall survival was similar for both groups of patients (26.7 months versus 25.2 months). Side effects and infections were more common in the group that received the combination therapy.
The study trial was supported by grants from National Cancer Institute and Genentech, manufacturer of Avastin.
Note to reporters: Contact Dean Forbes if you would like a copy of the embargoed paper, “Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer.”
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About Seattle Cancer Care Alliance
Seattle Cancer Care Alliance, established in 1998, unites the adult and pediatric cancer-care services of Fred Hutchinson Cancer Research Center, UW Medicine and Children’s Hospital and Regional Medical Center. A major focus of SCCA is to speed the transfer of new diagnostic and treatment techniques from the research setting to the patient bedside while providing premier, patient-focused cancer care. Patients who come to SCCA receive the latest research-based cancer therapies as well as cutting-edge treatments for a number of non-malignant diseases under development by its partner organizations. SCCA has three clinical-care sites: an outpatient clinic on the Fred Hutchinson campus, a pediatric-inpatient unit at Children’s and an adult-inpatient unit at UW Medical Center. For more information about SCCA, visit www.seattlecca.org.