Annals of Oncology Advance Access originally published online on July 29, 2008
Annals of Oncology 2008 19(12):2007-2011; doi:10.1093/annonc/mdn429
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breast cancer |
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.
Key words: 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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