Annals of Oncology Advance Access published online on July 29, 2008
Annals of Oncology, doi:10.1093/annonc/mdn429
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Adjuvant oral clodronate improves the overall survival of primary breast cancer patients with micrometastases to the bone marrow—a long-term follow-up
1 Department of Gynecology and Obstetrics, University of Heidelberg, Heidelberg, Germany
2 Institute for Gynecological Oncology, Mannheim, Germany
3 Department of Obstetrics and Gynecology, University of Tübingen, Germany
* Correspondence to: Prof. I. J. Diel, Institute for Gynecological Oncology, Quadrat P 7 16-17, 68161 Mannheim, Germany. Tel: +49-621-125064-20; Fax: +49-621-125064-29; E-mail: diel{at}cgg-mannheim.de
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.
Patients and 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.
Conclusion: These long-term survival data extend the survival advantage reported in previous studies with oral clodronate in breast cancer.
adjuvant therapy, bisphosphonate, breast neoplasm, clodronate
Received for publication April 27, 2008. Revision received June 18, 2008. Accepted for publication June 19, 2008.
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