"Improved overall survival demonstrates that gemcitabine with paclitaxel should be a standard frontline regimen in treating breast cancer that has spread," said principal investigator and first author Dr. Kathy S. Albain, professor, division of hematology/oncology, Department of Medicine, Loyola University Chicago Stritch School of Medicine, Maywood, Ill.
Albain designed and chaired this international trial that directly resulted in the FDA's very recent approval of gemcitabine for breast cancer. In previous years, the FDA has approved gemcitabine for other cancers. The drug disrupts cell replication by incorporating itself directly into the DNA.
The research applies to women who have never had chemotherapy for their advanced breast cancer but were already exposed to the anticancer class of drugs known as anthracyclines when their breast cancer was first diagnosed in an early stage.
Participating in the study were 529 patients randomized at 98 sites in 19 countries. The study compared gemcitabine plus paclitaxel to paclitaxel alone in women with metastatic breast cancer.
A total of 267 patients (median age: 53 years) received gemcitabine plus paclitaxel; another 262 patients (median age: 52 years) received paclitaxel alone. Albain reported that median overall survival was 18.5 months for gemcitabine with paclitaxel, and 15.8 months for paclitaxel alone.
"One year survival was 71 percent in the group that received the combination therapy, compared to 61 percent for the group treated with paclitaxel alone," said Albain, director, Breast Research Program; co-director of the multidisciplinary Breast Oncology Center; and director of the Thoracic Oncology Program, Cardinal Bernardin Cancer Center, Loyola University Health System, Maywood, Ill. The gemcitabine plus paclitaxel combination resulted in a 26 percent reduction in breast cancer deaths when all other factors were taken into account.
"These results are important because it was uncertain if earlier findings would translate into overall survival benefit," said Albain. "Now, we know they do."
Last year's results showed that the drug combination therapy significantly slowed the rate of tumor progression and improved patient quality of life.
That research also found that gemcitabine provided pain relief in symptomatic patients.
"Today's interim overall survival report greatly strengthens the 2003 findings," said Albain. "It is a major development in the battle against breast cancer."
The study also found that 55 percent of those taking paclitaxel alone stopped the therapy, due to disease progression, in contrast to only 38 percent of the combination drug group.
Co-authors of the study are K. S. Albain; S. Nag; G. Calderillo-Ruiz; J. P. Jordaan; A. Llombart; A. Pluzanska; M. Pawlicki; J.M. Reyes; A. S. Melmed; and J. O'Shaughnessy.
This study was funded by Eli Lilly and Company.
For more information on Loyola University Health System, log onto http://www.luhs.org.
The American Society of Clinical Oncology annual meeting at the Ernest N. Morial Convention Center, New Orleans, runs through June 8, 2004.
Loyola University Health System, a wholly owned subsidiary of Loyola University Chicago, includes Loyola University Medical Center (LUMC), 18 specialty and primary care centers in the western and southwestern suburbs, the Loyola Ambulatory Surgery Center at Oakbrook, the Loyola Imaging Center at Oakbrook Terrace, and serves as co-owner-operator of RML Specialty Hospital, a long-term-care facility for ventilator-dependent patients in suburban Hinsdale, Ill. LUMC, a private, academic health care institution, is nationally recognized for its specialty care and research in such areas as cancer, cardiology and cardiovascular surgery, pediatrics, neonatology and neurosciences, burn and trauma care and organ transplantation. The 73-acre campus in Maywood, Ill., includes the 523-bed licensed Loyola Hospital with a Level I trauma center, Russo Surgical Pavilion, Cardiovascular Institute, Cardinal Bernardin Cancer Center, Ronald McDonald Children�fs Hospital of LUMC, Loyola University Chicago Stritch School of Medicine, the Loyola Outpatient Center, the region�fs largest burn unit and one of the Midwest�fs largest and most comprehensive organ transplant programs.