Retrospective Statistical Analysis Corroborates Early Results Of Randomized Breast Cancer Trials

randomized trials can be replaced, but careful statistical analysis of patient registries, databases of patient characteristics and treatment information, can provide information to direct further inquiry, he said.

"There are circumstances, in which 'non-randomized' comparisons can be informative, and they can be even more informative when the sample sizes are large," Berry said. "These circumstances are present when assessing possible benefits of bone marrow transplant in metastatic breast cancer." Berry's statistical analysis compared metastatic breast cancer patients who participated in four clinical trials conducted by the Cancer and Leukemia Group B (CALGB) with that of metastatic breast cancer patients included in the Autologous Blood and Marrow Transplant Registry (ABMTR). The 663 CALGB patients included had been treated with various conventional chemotherapy regimens from 1980 to 1992, while the 638 ABMTR patients were treated with various regimens of high-dose chemotherapy with bone marrow or stem cell transplants from 1989 to 1995.

The CALGB trials were initially conducted to compare various chemotherapy regimens, but no survival differences were seen for patients with metastatic breast cancer, within each trial or across the trials. Berry looked for treatment-related differences within ABMTR, but found none. Thus the two separate patient groups were compared to see if the high dose chemotherapy used in ABMTR provided any survival benefit for metastatic breast cancer patients.

As the standard for evaluating new treatments, randomized clinical trials usually pit a new cancer treatment against the standard treatment to see if one is more effective or has fewer or more-tolerable side effects. Patients who meet requirements and agree to enter the trials are randomly assigned into the group getting the standard therapy or the group getting the experimental therapy.

Hundreds of patients are usually needed for researchers to

Contact: Joanna Downer
Duke University Medical Center

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