Sally W. Wade

Prevalence of bone metastases and bone-targeting agent use among solid tumor patients in the United States

Purpose Patients with bone metastases are at an increased risk of experiencing morbidity due to bone complications, and bone-targeting agents (BTA) are indicated for the prevention of these complications. Population-based estimates of the prevalence of bone metastases associated with solid tumors, and current treatment patterns for these patients, are limited. This study was undertaken to estimate the prevalence of bone metastases from solid tumors and to describe recent trends in the use of BTA in the US. Methods We estimated the prevalence of bone metastases in the US in 2012 using data from Medicare fee-for-service and PharMetrics Plus, a large commercial claims database. We evaluated the proportion of patients with bone metastases who were treated with BTA in 2012, timing of initiation of BTA relative to bone metastasis diagnosis, and persistence on BTA, overall and by primary tumor type and treatment. Results There were ~330,000 (168,063 Medicare fee-for-service; 162,239 other) patients aged ≥18 years living with solid tumors and bone metastases in 2012. BTA were used by 43% (Commercial) to 47% (Medicare) of patients in 2012, with the greatest use among breast cancer patients. Over half (Medicare: 57%; Commercial: 53%) of BTA-treated patients initiated BTA after experiencing a bone complication. Conclusion Of the estimated 330,000 solid tumor patients living with bone metastases in the US in 2012, many may have received less than optimal care to prevent bone complications during the calendar year.

Impact of Medication Adherence on Health Care Utilization and Productivity: Self-Reported Data From a Cohort of Postmenopausal Women on Osteoporosis Therapy

BACKGROUND Many pharmacologic agents are approved for the prevention and treatment of osteoporosis, which is common among postmenopausal women. Evidence exists relating treatment persistence to fracture risk. Less is known about treatment persistence and the use of health care service and individual productivity. OBJECTIVE This study was undertaken to describe health care use and productivity loss relative to osteoporosis medication persistence using womens self-reported data from the Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US™), a large, longitudinal (October 2004-December 2009) osteoporosis cohort study of postmenopausal women. METHODS Analyses included women on pharmacologic osteoporosis therapy (alendronate, risedronate, ibandronate, calcitonin, raloxifene, or teriparatide) who provided health care use/productivity data collected using semiannual questionnaires over 1 year of follow-up. Participant characteristics, use, and productivity metrics were summarized. Logistic regression models and generalized linear models were used to examine use, time missed from usual activities, number of days spent in bed, and lost work time relative to treatment persistence, adjusting for potential confounders. RESULTS At entry, of the 2528 women studied (91% white, 3.1% Hispanic/Latino, 2.3% African American/black, 1.1% Asian, and 2.1% American Indian/Native Alaskan, Native Hawaiian/Pacific Islander, or other; mean age, 64.6 [range, 37-97] years), 43.1% had osteoporosis and 23.4% had a previous fracture. After adjustment, subjects who switched therapies during follow-up were more likely to have had any kind of diagnostic testing (95.2% of switchers vs 91.2% of persistent subjects and 88.9% of discontinuers, P < 0.05). Discontinuers were less likely than persistent subjects to visit their primary care physicians (92.0% vs 94.4%, P = 0.0337). Variations in the number of days spent in bed, time missed from usual activities, and work loss (n = 852 employed subjects) by treatment persistence were not significant. CONCLUSIONS Use of diagnostic testing differed significantly by osteoporosis treatment status. Compared with women who persisted with treatment, primary care provider visits were less common among those who discontinued treatment. Treatment persistence was not associated with significant differences in productivity measures.

Prevalence of renal impairment and use of nephrotoxic agents among patients with bone metastases from solid tumors in the United States.

The renal status of patients with bone metastases secondary to solid tumors and their treatment with nephrotoxic agents is not well characterized. This retrospective study analyzed electronic medical records data from US‐based oncology clinics to identify adult (age ≥18) solid tumor patients with first bone metastasis diagnosis and ≥1 serum creatinine recorded between January 1, 2009 and December 31, 2013. Patients with multiple myeloma, multiple primary tumor types, acute renal failure, and/or end‐stage renal disease were excluded. Using the Chronic Kidney Disease Epidemiology Collaboration formula, we determined the prevalence of renal impairment (RI: single estimated glomerular filtration rate [eGFR] value <60 mL/min per 1.73 m2) and chronic kidney disease (CKD: ≥2 eGFR values <60, at least 90 days apart). We also examined the use of intravenous bisphosphonates (IV BP) and other nephrotoxic agents. Approximately half of the 11,809 patients were female. Breast (34%) and lung (28%) tumors were the most common. At bone metastasis diagnosis, mean age was 67 years and 24% of patients exhibited RI. The 5‐year prevalence was 43% for RI and 71% for CKD among RI patients. Nearly half (46%) of CKD patients received IV BP in the 12 months following their confirming eGFR and 13% of these patients received at least one other nephrotoxic agent during that period. This is the first US‐based study to examine the prevalence of RI among patients with bone metastases from solid tumors. RI is common at bone metastases diagnosis, and a substantial proportion of patients develop RI or CKD as their disease progresses. Whenever possible, treatments that are potentially less damaging for the kidney should be considered for patients with or predisposed to RI.

Physician Differences in Managing Postmenopausal Osteoporosis

AbstractBackground: Osteoporosis is a disease that often goes undetected until a fracture occurs. Previous reports indicate that disease diagnosis and care of patients with osteoporosis may vary within the medical community. Objective: Using data from the POSSIBLE US™ registry (October 2004–December 2009), we evaluated patterns of care for a group of primary care (i.e. first-contact) physicians who frequently prescribe osteoporosis medications to determine whether variations existed in the characteristics of their postmenopausal patients; physician approaches to diagnosis; treatment choices and monitoring; and patient-reported medication use. Methods: POSSIBLE US™ was a large prospective registry of postmenopausal women receiving osteoporosis treatment. We analysed data from 42 family practice physicians (FPPs), 50 internal medicine specialists (IMs) [internists, physicians], 41 gynaecologists (GYNs) and the 4917 patients they enrolled in the POSSIBLE US™ registry between October 2004 and January 2007. Women who had been postmenopausal for at least 1 year and who were newly initiating osteoporosis therapy, switching or augmenting therapy or continuing on a stable therapy regimen were investigated. Therapies included bisphosphonates, full-length or peptide derivative of parathyroid hormone, calcitonin, oral or transdermal postmenopausal estrogen, selective estrogen receptor modulators (SERMs), calcium and/or vitamin D supplements (alone or in combination with other therapies), or any combination of these agents. Data on physician characteristics were collected on an initial qualification questionnaire. Physicians reported data for enrolled patients at study entry and were also asked to provide relevant data obtained at clinic visits throughout the follow-up period. Patient-reported data were collected using questionnaires mailed out semi-annually throughout the follow-up period. Patient-reported and physician-reported data were assessed using ANOVA models and chi-squared (χ2) or Cochran-Mantel-Haenszel tests to evaluate differences across physician types. Multivariate logistic regression models examined the odds of patients having an osteoporosis diagnosis, being prescribed specific agents and receiving an additional dual energy x-ray absorptiometry (DXA) scan after the initial diagnostic scan. Cox proportional hazards regression models were used to determine whether the risk of patient-reported treatment discontinuation during 12 months of follow-up differed by physician characteristics. Results: Although low-bone density diagnoses were not required, physicians reported DXA as the method of diagnosis in 84% of patients. The majority of patients were prescribed bisphosphonates (55%); the next most frequently prescribed treatment was calcium/vitamin D only (19%). Women treated by GYNs were younger; had fewer co-morbidities, higher T-scores and fewer prior fractures; were 30% less likely to carry a diagnosis of osteoporosis; and were more likely to be treated with SERMs or hormone replacement therapy (HRT) than women treated by IMs or FPPs. Patients cared for by physicians with >30 years of experience were 20% less likely to carry a diagnosis of osteoporosis, had greater odds of receiving either HRT or calcium/vitamin D only and had a higher risk of treatment discontinuation. Overall, there was less laboratory testing to assess secondary causes of osteoporosis in this cohort than might have been expected, given the high incidence of secondary osteoporosis generally in women of similar age. Conclusions: This study documents potentially important variations in osteoporosis care, even among physicians who frequently prescribe osteoporosis medications.

An Observational Study of Concomitant Use of Emerging Therapies and Denosumab or Zoledronic Acid in Prostate Cancer

PURPOSE This observational study of oncologic clinical practices was designed to describe real-world patterns of use of emerging therapies (abiraterone acetate, cabazitaxel, enzalutamide, radium-223, sipuleucel-T) in patients with castration-resistant prostate cancer and to characterize their concomitant use with denosumab or zoledronic acid. METHODS A retrospective cohort study was conducted using a database of electronic health records from oncology practices across the United States. Eligible patients had a diagnosis of prostate cancer (International Classification of Diseases, Ninth Revision [ICD-9] code 185/International Classification of Diseases, Tenth Revision [ICD-10] code C61) before or concurrent with a visit between January 1, 2013, and December 31, 2015; follow-up was performed through June 30, 2016. From this population, we identified those who received an emerging therapy and a subset who also received denosumab or zoledronic acid. FINDINGS A total of 71,606 men met the eligibility criteria, and 5131 (7%) received emerging therapy. In the emerging therapy cohort (at the time of the first use), median age was 75 years, median prostate-specific antigen value was 22.7 ng/mL, 56% had bone metastases, and 80% were docetaxel naive. Abiraterone and enzalutamide were the most commonly used first emerging therapies (52% and 31%, respectively), followed by sipuleucel-T (9%), cabazitaxel (5%), and radium-223 (1.5%). Of the emerging therapy cohort, 3121 patients (61%) received concomitant denosumab (70%) or zoledronic acid (35%); 5% received both. IMPLICATIONS Among patients with prostate cancer treated in the United States, most of those treated with an emerging therapy between 2013 and 2015 also received denosumab or zoledronic acid, suggesting that the concomitant use of these therapy types is currently a common practice. Use of denosumab or zoledronic acid was higher in patients with verified bone metastases.

Corrigendum to “Prevalence of Fracture Risk Factors in Postmenopausal Women Enrolled in the POSSIBLE US Treatment Cohort”

[This corrects the article DOI: 10.1155/2013/715025.].