Influence of zoledronic acid on disseminated tumor cells (DTC) in primary breast cancer patients.

摘要: CTRC-AACR San Antonio Breast Cancer Symposium: 2008 Abstracts Abstract #2048 Background: The presence of disseminated tumor cells (DTC) in the bone marrow is associated with an increased risk for subsequent metastases. Bisphosphonates reduce occurence metastases patients (pts) primary breast cancer (BC) DTC. aim this trial was to evaluate effect adjuvant zoledronic acid (ZOL) on DTC and Patients methods: Eligibilty criteria prospective, randomized multicenter were BC pts (pT1-4, N1-2, M0) positive status as determined by a standardized immunocytochemistry staining procedure. Ninety-eight enrolled between April 2002 January 2006. Randomization medication had be started within 28 days surgery. Consenting treatment arm (ZOL 4mg i.v. q 4 weekly) or control arm. During study, all received form chemotherapy ± hormonal therapy alone. Bone aspirations performed analyze at surgery (baseline) 12 months later. Efficacy tolerability intravenous ZOL Result: available 76 both baseline after At median 2.0 / range 1-6 (mean 2.1±1.1) detected group 1-35 2.9±5.5) group. In groups number decreased during follow-up 0.5±0.8 (median 0.0; 0-2) 0.9±0.8 1.0; By ANCOVA analysis trend seen towards reduction compared (p=0.066). addition, marrow-positive treated more likely become negative (66.7% versus 35.1%, (p=0.009) Most frequently reported AEs musculoskeletal,arthralgia myalgia Conclusions: first randomized, we able show, that have baseline. There tendency More under achieved change from than controls (p=0.009). Treatment safe well tolerated. Citation Information: Res 2009;69(2 Suppl):Abstract nr 2048.