Ten-year follow-up of a randomized controlled trial of adjuvant clodronate treatment in node-positive breast cancer patients

Abstract

527 Background: There are three studies available of the effect of adjuvant bisphosphonate treatment on survival in primary operable breast cancer with conflicting results. We here present the extended 10 year follow-up result of the Finnish adjuvant clodronate study. Methods: Between 1990 and 1993, 299 women with primary node positive breast cancer were randomized to oral clodronate 1600 mg daily (149) or control groups (150) for three years. All patients received adjuvant chemo- or endocrine therapy. The final population was 282 patients. Intent-to-treat analyses were also performed. Pretreatment characteristics were well balanced between the groups except PgR receptor status. In the clodronate group there were more PgR negative patients (p = 0.03). Results: Within ten years bone metastases were detected at the same frequency in the clodronate and control groups: 44 (32 %) vs. 42 (29 %), respectively, (p = 0.35). The frequency of nonskeletal recurrences (visceral and local) was significantly higher in t...