High-dose chemotherapy with peripheral blood progenitor cell support in breast cancer: WSG AM01 and MM01

The WSG as a German interdisciplinary group initiated 05/94 a large multicentre phase III trial to evaluate adjuvant high-dose chemotherapy in high-risk breast cancer. About 100 centres all over Germany participated. The second trial in metastatic breast cancer (MBC) was initiated in 4/97 in co-operation with the German Intergroup. The main characteristics of the two trials are listed in Table 1.

Table 1

The first trial tests high-dose Tandem E90C3000T400 + PBPC versus dose-dense conventional chemotherapy with G-CSF support. All patients received irradiation of the chest wall and the supraclavicular lymph nodes, and tamoxifen in case of ER+ tumors. The trial will probably be closed by the end of the year. The first interim analysis was done in 1/99, and the second one is planned in 1/02. Interim data will be presented. The trial in MBC randomizes chemosensitive, ER-negative patients to 1× versus 2× STAMPV. The first interim analysis was done in 12/00. Data will be presented.