在希腊现实临床环境中，化疗后使用芳香化酶抑制剂对雌激素受体阳性早期乳腺癌女性骨健康的影响：希腊乳腺外科医生协会开展的POCHARBI试验结果

Impact of chemotherapy followed by aromatase inhibitors on bone health of women with ER-positive early breast cancer in real world clinical settings in Greece: Results of the POCHARBI trial conducted by the Hellenic Society of Breast Surgeons.

作者信息

Markopoulos C, Koukouras D, Venizelos V, Karyda I, Xepapadakis G, Misitzis J, Kalogerakos K, Poulakaki F, Natsiopoulos J, Zobolas V, Savidou C, Antonopoulou Z, Tzoracoleftherakis E

机构信息

Hellenic Society of Breast Surgeons, 6 Eslin Str, PC. 11523 Athens, Greece.

出版信息

Breast. 2016 Jun;27:27-34. doi: 10.1016/j.breast.2016.02.007. Epub 2016 Mar 20.

DOI:10.1016/j.breast.2016.02.007

PMID:27212697

Abstract

INTRODUCTION

The aim of this observational study was to assess the combined impact of chemotherapy (CT) and aromatase inhibitors (AI) therapy on bone mineral density (BMD) in postmenopausal women with estrogen receptor (ER)-positive early breast cancer.

METHODS

Patients were treated with a third generation AI, either as adjuvant therapy (HT cohort, n = 166) or as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort, n = 124), and were followed up for a 12-month period. BMD was evaluated at lumbar spine (LS) and total hip (HP) before CT, before AI therapy and after 12 months of AI therapy. The primary study objective was changes in LS BMD between pre CT treatment and post 12 months AI therapy in the CT cohort.

RESULTS

There were no statistically significant changes in LS BMD, either within CT or HT cohort. In the CT cohort, the mean LS BMD change was -0.72% (95% CI: -2.97%, +1.53%, p = 0.5526) between CT start and month 12 of AI therapy, while it was -0.19% (95% CI: -2.12%, +1.74%, p = 0.8309) and -0.59% (95% CI: -3.18%, +2.00%, p = 0.4759) between CT start and AI start and AI start and month 12 of AI therapy respectively. The mean change in LS BMD in the HT cohort (i.e. after 12 months of AI treatment) was +1.51% (95% CI: -0.96%, +3.98%, p = 0.7420).

CONCLUSIONS

The results of this study indicate that, under routine clinical practice, most postmenopausal patients who receive CT before AI therapy do not experience debilitating BMD consequences during the first year of AI treatment.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT01298362.

摘要

引言

本观察性研究的目的是评估化疗（CT）和芳香化酶抑制剂（AI）联合治疗对雌激素受体（ER）阳性早期乳腺癌绝经后女性骨密度（BMD）的综合影响。

方法

患者接受第三代AI治疗，作为辅助治疗（HT队列，n = 166）或在初始化疗治疗后作为后续内分泌治疗（CT队列，n = 124），并随访12个月。在CT前、AI治疗前以及AI治疗12个月后评估腰椎（LS）和全髋（HP）的骨密度。主要研究目标是CT队列中CT治疗前与AI治疗12个月后LS骨密度的变化。

结果

CT队列或HT队列中，LS骨密度均无统计学上的显著变化。在CT队列中，从CT开始至AI治疗第12个月，LS骨密度的平均变化为-0.72%（95%置信区间：-2.97%，+1.53%，p = 0.5526），而从CT开始至AI开始以及从AI开始至AI治疗第12个月，LS骨密度的平均变化分别为-0.19%（95%置信区间：-2.12%，+1.74%，p = 0.8309）和-0.59%（95%置信区间：-3.18%，+2.00%，p = 0.4759）。HT队列（即AI治疗12个月后）LS骨密度的平均变化为+1.51%（95%置信区间：-0.96%，+3.98%，p = 0.7420）。