title: Influence of zoledronic acid on disseminated tumor cells in primary breast cancer patients.
abstract: BACKGROUND
  The presence of disseminated tumor cells (DTCs) in bone marrow of patients with early breast cancer (EBC) has been correlated with increased risk of metastatic disease or locoregional relapse. Zoledronic acid (ZOL) treatment has reduced DTCs in the bone marrow of patients with EBC in several studies. This controlled study sought to confirm these observations.
  
  
  METHODS
  Patients with EBC and DTC-positive bone marrow were randomized (N = 96) to treatment with ZOL plus adjuvant systemic therapy or adjuvant systemic therapy alone. The change in DTC numbers at 12 months versus baseline was measured.
  
  
  RESULTS
  DTC-positive patients treated with ZOL were more likely to become DTC-negative after 12 months of treatment compared with the controls (67% versus 35%; P = 0.009). At 12 months, DTC counts decreased to a mean of 0.5 ± 0.8 DTCs in the ZOL group and to 0.9 ± 0.8 DTCs in the control group. In addition, ZOL was generally well tolerated.
  
  
  CONCLUSIONS
  Treatment with ZOL improves elimination of DTCs. Further studies are needed to determine whether the reduction in DTCs by ZOL provides clinical benefit.
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg. Electronic address: erich.solomayer@uks.eu.
authors.forename: E-F
authors.initials: EF
authors.lastname: Solomayer
authors.affiliation: Department of Gynecology and Obstetrics, University of Heidelberg, Heidelberg.
authors.forename: G
authors.initials: G
authors.lastname: Gebauer
authors.affiliation: Department of Radiation Oncology, Central Academic Hospital, Bielefeld.
authors.forename: P
authors.initials: P
authors.lastname: Hirnle
authors.affiliation: Department of Gynecology and Obstetrics, Heinrich-Heine University, Düsseldorf.
authors.forename: W
authors.initials: W
authors.lastname: Janni
authors.affiliation: Department of Gynecologic Oncology, Hannover Medical School, Hannover, Germany.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Lück
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg.
authors.forename: S
authors.initials: S
authors.lastname: Becker
authors.affiliation: Breast Center, Department of Senologie, Kantonsspital St. Gallen, St. Gallen, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg.
authors.forename: B
authors.initials: B
authors.lastname: Krämer
authors.affiliation: Norvartis Oncology, Department of Medical Affairs, Nuremberg.
authors.forename: B
authors.initials: B
authors.lastname: Wackwitz
authors.affiliation: Department of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Wallwiener
authors.affiliation: Department of Obstetrics, Gynecology, and Reproductive Medicine, University of Saarland, Homburg.
authors.forename: T
authors.initials: T
authors.lastname: Fehm
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018771:Arthralgia / Q000139:chemically induced; D001854:Bone Marrow Cells / Q000473:pathology*; D001859:Bone Neoplasms / Q000517:prevention & control* / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004164:Diphosphonates / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009360:Neoplastic Cells, Circulating / Q000473:pathology*; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D000970:Antineoplastic Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid