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Retrospective Statistical Analysis Corroborates Early Results Of Randomized Breast Cancer Trials

ATLANTA -- Using data on almost 1,300 patients with advanced breast cancer, researchers from Duke University and other institutions have found no benefit from high dose chemotherapy followed by bone marrow transplantation. They prepared their findings for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO).

The researchers' conclusions are supported by early results of two metastatic breast cancer trials also being presented at ASCO. Unlike these ongoing randomized trials, however, the Duke conclusions come from analysis of metastatic breast cancer patients treated in the 1980s and early 1990s. Patients with metastatic cancer are those in whom cancer cells have moved from the original malignancy to other parts of the body. According to the American Cancer Society, the five-year relative survival rate for patients with early stage breast cancer is 97%, but the rate for patients with distant metastases is just 22%, similar to the survival of patients in Berry's study.

Half of the analyzed patients had been included in one of four clinical trials and were all treated with standard doses of chemotherapy. The other half were treated with high-dose chemotherapy and bone marrow transplant outside of clinical trials and were included in a patient registry, a compilation of treatment information and patient characteristics.

"We found no benefit for metastatic breast cancer patients treated with high-dose chemotherapy and bone marrow transplant, even adjusting for patient characteristics such as estrogen receptor status, age, and metastatic sites," said lead author Donald Berry, professor in the Institute of Statistics and Decision Sciences at Duke. "Moreover, we could find no subset of metastatic patients for whom transplant was beneficial." Berry emphasized that the analysis shows it is possible to determine two treatments' relative abilities without a randomized clinical trial. He does not believe that
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Contact: Joanna Downer
downe010@mc.duke.edu
919-684-4148
Duke University Medical Center
15-May-1999


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