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. Patients and 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.
| Original language | English |
|---|---|
| Article number | mdr612 |
| Journal | Annals of Oncology |
| Volume | 23 |
| Issue number | 9 |
| Pages (from-to) | 2271-2277 |
| Number of pages | 7 |
| ISSN | 0923-7534 |
| DOIs | |
| Publication status | Published - 01.09.2012 |
Funding
This work was supported by a research grant from Novartis Pharmaceuticals Corporation (ZOL-MRD 001). Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals Corporation. Dr EFS has received honoraria from Novartis, Roche, and AstraZeneca, and research grants from Roche. Dr WJ has received lecture honoraria and research grants from Novartis. Dr H-JL has received lecture honoraria from Roche, Novartis, Sanofi, GlaxoSmithKline, and Pfizer, and is an advisory board member for Roche, Novartis, Pfizer, Fresenius, and BMS. Dr JH has received lecture honoraria from Novartis, and is an advisory board member for Roche, Novartis, and Amgen. Dr TF has received honoraria from Roche, Novartis, and AstraZeneca, and research grants from Roche. Dr BW is employed by Novartis. Dr DW has received research grants from Novartis and Roche. Drs GG, PH, SB, and BK have declared no conflict of interest.
