Bone marrow micrometastases predict Ca risk.(Gynecology)

SAN ANTONIO -- The presence of disseminated tumor cells in bone marrow at initial diagnosis of nonmetastatic breast cancer independently predicted a greater than twofold increased relative risk of overall mortality and other end points in a pooled analysis of 4,703 patients, Dr. Stephan Braun reported at a breast cancer symposium sponsored by the Cancer Therapy and Research Center.

"This is level 1 evidence of the prognostic significance of disseminated tumor cells in bone marrow for patients with stage I-III breast cancer," said Dr. Braun of the department of ob.gyn. at the Medical University of Innsbruck, Austria.

These disseminated tumor cells (DTC), also known as bone marrow micrometastases, have generally been thought to be predictive only of distant bone metastases, but that wasn't so in the pooled analysis of nine clinical trials conducted in Europe and New York. Instead, DTC-positive patients had an increased risk of multiple distant metastases to both visceral organs and bone, he said. Based on the pooled analysis findings, a multicenter randomized clinical trial will begin this spring in Austria, Norway, and Germany in which DTC will be put to the test prospectively both for risk stratification and as an early surrogate for therapeutic efficacy. Postmenopausal women with hormone receptor-positive early breast cancer and DTC will be randomized to adjuvant anastrozole with or without fulvestrant. The primary end point will be the presence or absence of DTC after 12 months.

In the pooled analysis, 31% of the 4,703 women were found to have DTC at diagnosis of stage I-III breast cancer. Although the prevalence increased with greater tumor size and more extensive lymph node involvement, it's worth emphasizing that fully one in four women with no positive lymph nodes had DTC, as did a similar fraction of women with T1 tumor size, according to Dr. Braun. During a median 5.2-year follow-up, 32% of patients with DTC developed distant metastases, ...