Dataset Information

Guidelines for Osteoprotection in Breast Cancer Patients on an Aromatase Inhibitor.

ABSTRACT: Postmenopausal women are at an increased risk of osteopenia and osteoporosis due to the physiologic loss of the bone protective effects of estrogen. Additionally, disease-related risk factors also contribute to the increased fracture risk. To further complicate matters, one of the most common and severe safety issues associated with cancer therapies for breast cancer patients is bone loss and the associated increased risk of fractures. These facts underscore the need to carefully monitor bone mineral density in patients with endocrine-responsive breast cancer, and to consider adjuvant therapy that may help manage and/or prevent bone loss and fracture. Aromatase inhibitors (AIs) are now in widespread clinical use for women with hormone receptor-positive breast cancer and have replaced tamoxifen as the gold standard of care. AIs target the estrogen biosynthetic pathway and deprive tumor cells of the growth-promoting effects of estrogen. These treatments provide significant benefit to patients in terms of improved disease-free and overall survival. Adversely, there is a concern of an increased risk of bone loss with prolonged therapy consequently leading to an increased fracture risk. This manuscript will review the recent literature pertaining to AI-associated bone loss and discuss suggested management and preventative approaches that may help patients remain on therapy to derive the most clinical benefits.

SUBMITTER: Hadji P

PROVIDER: S-EPMC3132952 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

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Guidelines for Osteoprotection in Breast Cancer Patients on an Aromatase Inhibitor.

Hadji Peyman P

Breast care (Basel, Switzerland) 20101019 5

Postmenopausal women are at an increased risk of osteopenia and osteoporosis due to the physiologic loss of the bone protective effects of estrogen. Additionally, disease-related risk factors also contribute to the increased fracture risk. To further complicate matters, one of the most common and severe safety issues associated with cancer therapies for breast cancer patients is bone loss and the associated increased risk of fractures. These facts underscore the need to carefully monitor bone mi ...[more]

PMID: 21779210

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Project description:LESSONS LEARNED:Studies targeting the androgen receptor (AR) signaling pathway in aromatase inhibitor (AI)-resistant breast cancer are limited. Bicalutamide, one of the commonly used AR inhibitors in prostate cancer, in combination with AI, did not show synergistic activity in patients with estrogen receptor-positive and AI-resistant disease in this phase II, single-arm study. The clinical benefit rate and objective response rate at 6 months were 16.7% and 0%, respectively, and the study was terminated after the first stage. BACKGROUND:Endocrine resistance is a major problem in clinical practice. Studies have shown that androgen receptor (AR) signaling activation may be one of the mechanisms, and targeting AR showed some promising results in AR-positive triple-negative breast cancer. The aim of this study was to assess the efficacy and safety of bicalutamide plus another aromatase inhibitor in patients with nonsteroidal aromatase inhibitor (AI) or steroidal AI resistance and estrogen receptor (ER)-positive and AR-positive advanced breast cancer. METHODS:A Simon's two-stage, phase II, single-arm study was conducted. We assumed the clinical benefit rate (CBR) of 40% would be significant in clinical practice. In this case, if ?4 patients of the 19 patients in the first stage benefited from treatment, the CBR would achieve the assumed endpoint. If fewer than four patients benefited from treatment in the first stage, the trial would be terminated. All patients received bicalutamide 50 mg per day orally plus another aromatase inhibitor. The primary outcome was CBR; secondary outcomes included objective response rate (ORR), progression-free survival (PFS), and tolerability. RESULTS:A total of 19 patients enrolled in the first stage, and 18 patients met all criteria for analysis. The trial terminated according to protocol after the first stage. After a median follow-up of 14 months, the CBR at 6 months was 16.7% (3/18); no patients with partial or complete response were observed. The median PFS was 2.7 months. Bicalutamide in combination with AI was well tolerated. CONCLUSION:Bicalutamide in combination with another AI did not show synergistic activity in patients with ER-positive breast cancer and AI resistance. Results suggest that no more large-sample clinical trials should be conducted in this population for overcoming endocrine resistance.

Dataset Information

Guidelines for Osteoprotection in Breast Cancer Patients on an Aromatase Inhibitor.

Publications

Guidelines for Osteoprotection in Breast Cancer Patients on an Aromatase Inhibitor.

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