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Clinical Trial
. 2020 Apr;180(3):675-685.
doi: 10.1007/s10549-020-05567-9. Epub 2020 Mar 2.

Breast cancer outcome in relation to bone mineral density and bisphosphonate use: a sub-study of the DATA trial

Irene E G van Hellemond  1 , Carolien H Smorenburg  2 , Petronella G M Peer  3 , Astrid C P Swinkels  4 , Caroline M Seynaeve  5 , Maurice J C van der Sangen  6 , Judith R Kroep  7 , Hiltje de Graaf  8 , Aafke H Honkoop  9 , Frans L G Erdkamp  10 , Franchette W P J van den Berkmortel  11 , Wilfred K de Roos  12 , Sabine C Linn  13 , Alexander L T Imholz  14 , Maaike de Boer  1 , Vivianne C G Tjan-Heijnen  15   16 ; Dutch Breast Cancer Research Group (BOOG)
Affiliations
Clinical Trial

Breast cancer outcome in relation to bone mineral density and bisphosphonate use: a sub-study of the DATA trial

Irene E G van Hellemond et al. Breast Cancer Res Treat. 2020 Apr.

Abstract

Purpose: The phase III DATA study compared 6 and 3 years of adjuvant anastrozole following 2-3 years of tamoxifen in postmenopausal breast cancer patients. This pre-planned side-study assessed the relationship between a reduced bone mineral density (BMD) and distant recurrence-free survival (DRFS), and evaluated the effect of bisphosphonates on DRFS.

Methods: We selected all patients with a BMD measurement within 3 years after randomisation (landmark) without any DRFS events. Kaplan-Meier methods and Cox proportional hazards models were used for analyses.

Results: Of 1860 eligible patients, 1142 had a DEXA scan before the landmark. The BMD was normal in 436 (38.2%) and showed osteopenia in 565 (49.5%) and osteoporosis in 141 (12.3%) patients. After a median follow-up of 5.0 years from the landmark, neither osteopenia nor osteoporosis (compared with normal BMD) were associated with DRFS in both the 6-year [osteopenia HR 0.82 (95% CI 0.45-1.49), osteoporosis HR 1.10 (95% CI 0.26-4.67)] and the 3-year arm [osteopenia HR 0.75 (95% CI 0.40-1.42), osteoporosis HR 1.86 (95% CI 0.43-8.01)]. Moreover, bisphosphonate use did not impact DRFS.

Conclusion: No association was observed between a reduced BMD and DRFS. Neither did we observe an impact of bisphosphonates on DRFS.

Keywords: Aromatase inhibitor; Bisphosphonates; Bone health; Bone metastases; Breast cancer; Distant recurrence-free survival; Osteoporosis; Survival; Tamoxifen.

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Conflict of interest statement

IEGvH, SCL and ACPS report institutional grants from AstraZeneca during the conduct of the study. MdB reports research grants from Roche, Eisai, Novartis, Pfizer, and Lily during the conduct of the study; and consultation/speakers fee from Roche, Novartis, and Pfizer. VCGT-H reports consultant/advisory role to Pfizer, Lily, and Novartis, and grants to the institute for research from AstraZeneca, Roche, Novartis, Pfizer, and Lilly during the conduct of the study. FWPJvdB, FLGE, HdG, AH, ALTI, JRK, PGMP, WKdR, MJCvdS, CMS, CHS declare no conflicts of interests.

Figures

Fig. 1
Fig. 1
The impact of BMD on distant recurrence-free survival for the patients in a the 3-year anastrozole treatment arm, b the 6-year anastrozole treatment arm. Hazard ratios were adjusted for tumour size, nodal status, tumour grade and hormone receptor status
Fig. 2
Fig. 2
The impact of BMD on late DRFS selecting only the patients without bisphosphonates before the landmark in a the 6-year anastrozole treatment arm, b the 3-year anastrozole treatment arm. Hazard ratios were adjusted for tumour size, nodal status, tumour grade and hormone receptor status
Fig. 3
Fig. 3
The impact of bisphosphonate use before the landmark on late DRFS in the women with A) a normal BMD, B) osteopenia, and C) osteoporosis at the 3-year landmark
See this image and copyright information in PMC

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