4.7 Studies of Quality Holy Cross Hospital Bone Health Early Stage I ER/PR Positive Breast Cancer Patients December 13, 2017

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1 4.7 Studies of Quality Holy Cross Hospital 2017 Bone Health Early Stage I ER/PR Positive Breast Cancer Patients December 13, 2017

2 Bone Health in Stage I ER/PR Positive Breast Cancer Patients To review stage I ER/PR positive breast cancer patients on Aromatase Inhibitors (AI s) Was a DEXA scan performed within 6 months of starting AI s? Was oral Calcium and Vitamin D recommended? If there is a diagnosis of osteoporosis on DEXA scan was a bisphosphonate or equivalent therapy ordered? Implement standard of care to alert practicing clinician to initiate therapy with cancer treatment plan and document accordingly Follow these patients over time to monitor rate of bone fracture.

3 Aromatase Inhibitors Mechanism of action: suppresses estrogen levels by inhibiting or inactivating aromatase, enzyme responsible for conversion of androgens to estrogens DRUGS: Anastrozole (Arimidex), Letrozole (Femara) Indications: Post menopausal women, early stage ER+ breast cancers, help to decrease breast cancer recurrence

4 Bisphosphonate/RANKL Inhibitor Therapy Mechanism of action: specific inhibition of osteoclastmediated bone resorption DRUGS: Alendronate (Fosamax), Ibandronate (Boniva), Zoledronic Acid (Reclast IV), Risedronate (Actonel), Densenomab (Prolia/Xgeva) Indications: prevention and treatment of osteopenia and osteoporosis, bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer, or treat other bone disease

5 Bone Health in Stage I ER/PR Positive Breast Cancer Patients Introduction: Postmenopausal women as well as Stage I breast cancer patients on aromatase inhibitors (AI s) have an increased risk of developing osteoporosis and osteopenia. Osteoporosis is defined on a DEXA scan as a T-score less than Osteopenia is defined on a DEXA scan as a T-score that is between -1 and Normal T-score is above -1. Patients that are diagnosed with osteoporosis or osteopenia have an increased risk of bone fracture.

6 Bone Health in Stage I ER/PR Positive Breast Cancer Patients OBJECTIVE: The focus of this study is to evaluate bone health management in the treatment of stage I ER/PR positive breast cancer patients on AI s. Since AI s can lower bone mineral density, the outcome goal is to minimize this as much as possible by addressing bone health early, monitoring DEXA scan results, establish guidelines when osteoporosis or osteopenia has been confirmed, and follow patients over time to monitor rate of bone fracture. This study is our baseline foundation, to develop a process to help minimize bone density loss and decrease the risk for fractures of our stage I ER/PR positive breast cancer patients.

7 Bone Health in Stage 1 ER/PR Positive Breast Cancer Patients METHOD: Retrospective chart review and analysis Postmenopausal Stage I ER/PR positive breast cancer patients Diagnosed between July 1, 2016 and December 31, 2016 Prescribed AI s for at least 3 months. Further chart reviews were done to determine if : * a DEXA scan was performed within 6 months of starting AI s * Calcium or vitamin D was prescribed or recommended * Was there a diagnosis of osteoporosis or osteopenia from a DEXA scan * Bisphosphonate or equivalent therapies initiated Ongoing retrospective chart reviews will be conducted over time to determine the rate of bone fracture (if any) and establish approved guidelines to follow these patients with DEXA scan. T scores will be evaluated to determine the need for calcium/vitamin D and other therapies as appropriate.

8 Bone Health in Stage I ER/PR Positive Breast Cancer 9 8 Patient Age Demographics yrs yrs yrs yrs 90+ yrs

9 Bone Health Stage I ER/PR Positive Breast Cancer Patients

10 Bone Health Stage I ER/PR Positive Breast Cancer Patients CONCLUSION and RECOMMENDATIONS: Bone loss associated with the use of AI s is common among ER/PR positive breast cancer patients. Monitoring the extent of bone loss with a DEXA scan and adding a biphosphonate (or equivalent) will help decrease bone loss. At the conclusion of the first phase of this study, the results confirm the program has a clinical standard of care for stage I ER/PR positive breast cancer patients on AI s. Phase two will involve a review of the three patients that did not get a DEXA scan as well as continued retrospective chart reviews to monitor stage I ER/PR positive breast cancer patients. Guidelines: ncbi.nlm.nih.gov NCCN Task Force Report: Bone Health in Cancer Care