July 8, 2003
Stem Cell Therapy Doesn’t Improve Cancer Outcome
CHICAGO— Adding high-dose chemotherapy and bone marrow transplantation to conventional chemotherapy offers little benefit for women with primary breast cancer who are at high risk for recurrence, finds a study reported in the July 3 issue of The New England Journal of Medicine.
Moreover, toxicities from the transplantation offset any of its possible benefits, said Northwestern University’s Feinberg School of Medicine cancer researcher Martin S. Tallman, MD, one of the two senior authors on the Eastern Cooperative Oncology Group-coordinated study. Dr. Tallman’s co-senior author was Hillard M. Lazarus, MD, of Case Western Reserve University.
Results of the randomized clinical trial, which compared rates of breast cancer recurrence, disease-free survival, and overall survival, dispel a belief widely held during the 1990s that adjuvant high-dose chemotherapy with bone marrow transplant might be a viable treatment option and improve survival for women for women with aggressive, recurring breast cancers.
In the 1990s no randomized clinical trial was conducted to assess definitively the value of stem cell transplantation in breast cancer, although Phase II clinical studies and other reports suggested a three-year disease-free survival rate of about 65 to 70 percent.
The results published today were derived from data from more than 500 women with primary breast cancer with involvement of at least 10 lymph nodes under the arm who received six cycles of standard chemotherapy with cyclophosphamide, doxorubicin, and 5-fluorouracil with or without high-dose chemotherapy and stem cell transplantation.
The study showed the addition of stem cell transplantation provided no significant improvement in either disease-free survival or overall survival in women with Stage II or III breast cancer.
Time to recurrence was longer for patients who had received stem cell transplantation; however, nine patients on the stem cell transplantation arm of the study died. An additional nine patients on this arm developed leukemia or other bone marrow disorders.
“These results were not completely surprising, since earlier studies in metastatic cancer also did not confirm a benefit,” Dr. Tallman said.
“Our major focus for patients with high-risk breast cancer now centers on exciting new drugs and combinations rather than high-dose chemotherapy and transplant,” he said.
Dr. Tallman is professor of medicine at the Feinberg School and a researcher in The Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Dr. Lazarus is a researcher at Case Western Reserve University School of Medicine, Ireland Cancer Center, Cleveland.
Other investigators on the study were William J. Gradishar, MD, associate professor of medicine, Feinberg School; Robert Gray, Dana-Farber Cancer Institute, Boston; Nicholas J. Robert, MD, Inova Fairfax Hospital, Falls Church, Va.; Charles F. LeMaistre, MD, Texas Transplant Institute, San Antonio; C. Kent Osborne, MD, Breast Center, Baylor College of Medicine and Methodist Hospital, Houston; William P. Vaughan, MD, University of Alabama at Birmingham; Thomas M. Pisansky, MD, Mayo Clinic, Rochester, Minn.; John Fetting, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore; and Elisabeth Paietta, Our Lady of Mercy Cancer Center, New York Medical College, Bronx, New York.
This study was coordinated by the Eastern Cooperative Oncology Group and supported in part by grants from the U.S. Public Health Service, National Cancer Institute, National Institutes of Health, and U.S. Department of Health and Human Services.