title: Adjuvant oral clodronate improves the overall survival of primary breast cancer patients with micrometastases to the bone marrow: a long-term follow-up.
abstract: BACKGROUND
  Adding oral clodronate to postoperative adjuvant breast cancer therapy significantly improves disease-free survival (DFS) and overall survival (OS). Long-term follow-up data from the prospective, randomized, controlled study are reported.
  
  
  METHODS
  Patients with primary breast cancer received clodronate 1600 mg/day for 2 years or no treatment along with standard adjuvant breast cancer treatment.
  
  
  RESULTS
  Analysis of 290 of 302 patients demonstrated that a significant improvement in OS was maintained in the clodronate group at a median follow-up of 103 +/- 12 months; 20.4% of patients in the clodronate group versus 40.7% of control group patients (P = 0.04) died during the 8.5 years following primary surgical therapy. Significant reductions in the incidence of bony and visceral metastases and improvement in duration of DFS at 36- and 55-month follow-up periods were no longer seen with clodronate.
  
  
  CONCLUSIONS
  These long-term survival data extend the survival advantage reported in previous studies with oral clodronate in breast cancer.
authors.affiliation: Department of Gynecology and Obstetrics, University of Heidelberg, Heidelberg, Germany. diel@cgg-mannheim.de
authors.forename: I J
authors.initials: IJ
authors.lastname: Diel
authors.forename: A
authors.initials: A
authors.lastname: Jaschke
authors.forename: E F
authors.initials: EF
authors.lastname: Solomayer
authors.forename: C
authors.initials: C
authors.lastname: Gollan
authors.forename: G
authors.initials: G
authors.lastname: Bastert
authors.forename: C
authors.initials: C
authors.lastname: Sohn
authors.forename: F
authors.initials: F
authors.lastname: Schuetz
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001853:Bone Marrow / Q000473:pathology; D001859:Bone Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D004002:Clodronic Acid / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008408:Mastectomy; D008875:Middle Aged; D011878:Radiotherapy
chemical_list: D000970:Antineoplastic Agents; D050071:Bone Density Conservation Agents; D004002:Clodronic Acid