Press Release: Study Finds Shifts in Treatment Trends Prior to Publication of Study Results

Extract

The oral presentation of data from a single study at a national scientific conference can have an important impact on patient treatment, even before study publication or Food and Drug Administration (FDA) approval, according to a study in the March 15 issue of the Journal of the National Cancer Institute.

Specifically, the authors found that use of the chemotherapy drugs called taxanes increased after the May 1998 annual meeting of the American Society of Clinical Oncology (ASCO) where preliminary data were presented suggesting that use of taxanes as adjuvant therapy could improve survival in women with lymph node-positive breast cancer.

Results from the Cancer and Leukemia Group B (CALGB) Study 9344 suggested that adjuvant treatment with the taxane drug paclitaxel is associated with improved survival in women with lymph node-positive breast cancer. The results were first presented at the 1998 ASCO meeting. Although paclitaxel had been approved by the FDA in 1994 for the treatment of women with metastatic breast cancer, FDA approval for this new use of paclitaxel for women with node-positive breast cancer did not come until October 1999. A final report of CALGB Study 9344 was published in 2003. However, the preliminary results of the study presented in May 1998 were highlighted in news stories published in numerous major media outlets, including the New York Times, Wall Street Journal, and U.S. News and World Report.