Management of Androgen Deprivation Therapy-Associated Hot Flashes in Men With Prostate Cancer.

PROBLEM IDENTIFICATION: To determine best practices for managing hot flashes associated with androgen deprivation therapy (ADT) in men with prostate cancer. LITERATURE SEARCH: The CINAHL®, Embase®, PsycINFO®, PubMed®, and Scopus® databases were used to identify randomized controlled trials (RCTs) and quasiexperimental studies published between January 1994 and June 2018. DATA EVALUATION: Using the Cochrane Handbook for Systematic Reviews of Interventions, the authors reviewed 15 studies examining the effects of pharmacologic or complementary and alternative medicine interventions on ADT-associated hot flashes in men with prostate cancer. SYNTHESIS: Pharmacologic interventions (e.g., cyproterone, medroxyprogesterone, megestrol acetate) showed some promise for reducing hot flashes but were associated with side effects and risks. Acupuncture demonstrated potential benefit in reducing hot flashes without side effects. IMPLICATIONS FOR RESEARCH: Evidence is insufficient to support interventions for ADT-associated hot flashes in men with prostate cancer. Future RCTs should be sufficiently powered, include a control group, and use standardized outcome measures.

Factors influencing prostate cancer treatment decisions for African American and white men.

BACKGROUND: Prostate cancer racial disparities in mortality outcomes are the largest in all of oncology, and less aggressive treatment received by African American (AA) patients versus white patients is likely a contributing factor. However, the reasons underlying the differences in treatment are unclear. METHODS: This study examined a prospective, population-based cohort of 1170 men with newly diagnosed nonmetastatic prostate cancer enrolled from 2011 to 2013 before treatment throughout North Carolina. By phone survey, each participant was asked to rate the aggressiveness of his cancer, and his response was compared to the actual diagnosis based on a medical record review. Participants were also asked to rate the importance of 10 factors for their treatment decision-making process. RESULTS: Among AA and white patients with low-risk cancer (according to National Comprehensive Cancer Network guidelines), 78% to 80% perceived their cancers to be "not very aggressive." However, among high-risk patients, 54% of AA patients considered their cancers to be "not very aggressive," whereas 24% of white patients did (P < .001). Although both AA and white patients indicated that a cure was a very important decision-making factor, AAs were significantly more likely to consider cost, treatment time, and recovery time as very important. In a multivariable analysis, perceived cancer aggressiveness and cure as the most important factor were significantly associated with receiving any aggressive treatment and were associated with surgery (vs radiation). After adjustments for these factors and sociodemographic factors, race was not significantly associated with the treatment received. CONCLUSIONS: Racial differences in perceived cancer aggressiveness and factors important in treatment decision making provide novel insights into reasons for the known racial disparities in prostate cancer as well as potential targets for interventions to reduce these disparities.

Analysis of Glycemic Control of a Pharmacist-Led Medication Management Program in Patients with Type 2 Diabetes.

BACKGROUND: An integrated health care system with its own regional health plan located in Texas implemented a pharmacist-led diabetes medication management program (MMP) to treat type 2 diabetic patients (baseline A1c > 7.5%). The MMP formed collaborative practice agreements with the system's physicians to allow ambulatory care pharmacists to modify and adjust diabetic drug regimens when appropriate. Enrolled MMP patients received personalized visits with ambulatory care pharmacists and a copay waiver on diabetes medications. OBJECTIVE: To study the outcomes of an outpatient, pharmacist-led MMP, along with a copay waiver on diabetes drugs, in treating adults with type 2 diabetes mellitus over a 2-year period compared with standard care practice. METHODS: This retrospective study employed a quasi-experimental design and used medical claims, pharmacy claims, eligibility data, and electronic medical records. Patients aged 18 to 62 years, who were diagnosed with type 2 diabetes mellitus, and had at least 1 diabetes-related pharmacy claim in the year before the MMP, as well as continuous enrollment in the health plan, were included. Patients enrolled in the pharmacist-led MMP for at least 2 years (n =75) were matched to standard care patients (n =75) on age, gender, baseline A1c, insulin use, and physical comorbidity. The primary outcome was the 2-year change in A1c. Secondary outcomes included inpatient costs, outpatient costs, and pharmacy costs from the baseline period (year before enrollment) compared with the follow-up period (second year of enrollment). RESULTS: After matching MMP patients (n = 75) to control patients (n = 75), the baseline A1c (9.30 and 9.26), the mean age (53.0 and 53.3, respectively), the Selim Physical Score (3.32 and 3.26, respectively), and the use of insulin (56.0% and 56.0%, respectively) were similar in both groups. MMP patients had a greater mean reduction in A1c compared with standard care patients (-1.24 vs. -0.59, P = 0.009) from baseline to after 2 years. After 2 years, the A1c for MMP patients was significantly lower compared with control patients (8.06 vs.8.67, respectively, P = 0.014). There was also a difference in A1c after 1 year for MMP patients versus control patients (8.18 and 8.69, respectively, P = 0.012). CONCLUSIONS: A pharmacist-led diabetes MMP, combined with a diabetes drug copay waiver, was effective in significantly reducing A1c over a 2-year period for type 2 diabetic patients in this regional health plan.

Associations between patient-provider communication and socio-cultural factors in prostate cancer patients: a cross-sectional evaluation of racial differences.

OBJECTIVE: To examine the association between socio-cultural factors and patient-provider communication and related racial differences. METHODS: Data analysis included 1854 men with prostate cancer from a population-based study. Participants completed an assessment of communication variables, physician trust, perceived racism, religious beliefs, traditional health beliefs, and health literacy. A multi-group structural equation modeling approach was used to address the research aims. RESULTS: Compared with African Americans, Caucasian Americans had significantly greater mean scores of interpersonal treatment (p<0.01), prostate cancer communication (p<0.001), and physician trust (p<0.001), but lower mean scores of religious beliefs, traditional health beliefs, and perceived racism (all p values <0.001). For both African and Caucasian Americans, better patient-provider communication was associated with more physician trust, less perceived racism, greater religious beliefs (all p-values <0.01), and at least high school education (p<0.05). CONCLUSION: Socio-cultural factors are associated with patient-provider communication among men with cancer. No evidence supported associations differed by race. PRACTICE IMPLICATION: To facilitate patient-provider communication during prostate cancer care, providers need to be aware of patient education levels, engage in behaviors that enhance trust, treat patients equally, respect religious beliefs, and reduce the difficulty level of the information.

Receipt of guideline-concordant treatment in elderly prostate cancer patients.

PURPOSE: To examine the proportion of elderly prostate cancer patients receiving guideline-concordant treatment, using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database. METHODS AND MATERIALS: A total of 29,001 men diagnosed in 2004-2007 with localized prostate cancer, aged 66 to 79 years, were included. We characterized the proportion of men who received treatment concordant with the National Comprehensive Cancer Network guidelines, stratified by risk group and age. Logistic regression was used to examine covariates associated with receipt of guideline-concordant management. RESULTS: Guideline concordance was 79%-89% for patients with low- or intermediate-risk disease. Among high-risk patients, 66.6% of those aged 66-69 years received guideline-concordant management, compared with 51.9% of those aged 75-79 years. Discordance was mainly due to conservative management-no treatment or hormone therapy alone. Among the subgroup of patients aged ≤76 years with no measured comorbidity, findings were similar. On multivariable analysis, older age (75-79 vs 66-69 years, odds ratio 0.51, 95% confidence interval 0.50-0.57) was associated with a lower likelihood of guideline concordance for high-risk prostate cancer, but comorbidity was not. CONCLUSIONS: There is undertreatment of elderly but healthy patients with high-risk prostate cancer, the most aggressive form of this disease.

Receipt of National Comprehensive Cancer Network guideline-concordant prostate cancer care among African American and Caucasian American men in North Carolina.

BACKGROUND: African Americans have a higher incidence of prostate cancer and experience poorer outcomes compared with Caucasian Americans. Racial differences in care are well documented; however, few studies have characterized patients based on their prostate cancer risk category, which is required to differentiate appropriate from inappropriate guideline application. METHODS: The medical records of a population-based sample of 777 North Carolina men with newly diagnosed prostate cancer were studied to assess the association among patient race, clinical factors, and National Comprehensive Cancer Network (NCCN) guideline-concordant prostate cancer care. RESULTS: African Americans presented with significantly higher Gleason scores (P = .025) and prostate-specific antigen levels (P = .008) than did Caucasian Americans. However, when clinical T stage was considered as well, difference in overall risk category only approached statistical significance (P = .055). Across risk categories, African Americans were less likely to have surgery (58.1% versus 68.0%, P = .004) and more likely to have radiation (39.0% versus 27.4%, P = .001) compared with Caucasian Americans. However, 83.5% of men received guideline-concordant care within 1 year of diagnosis, which did not differ by race in multivariable analysis (odds ratio = 0.83; 95% confidence interval = 0.54-1.25). Greater patient-perceived access to care was associated with greater odds of receiving guideline-concordant care (odds ratio = 1.06; 95% confidence interval = 1.01-1.12). CONCLUSIONS: After controlling for NCCN risk category, there were no racial differences in receipt of guideline-concordant care. Efforts to improve prostate cancer treatment outcomes should focus on improving access to the health care system.

Retrospective evaluation of the impact of copayment increases for specialty medications on adherence and persistence in an integrated health maintenance organization system.

BACKGROUND: Specialty drugs are generally defined as high-cost injectable, infused, oral, or inhaled drugs that require close monitoring. Specialty drugs account for an increasing percentage of total drug expenditures, and management of specialty drugs has become a priority. A Central Texas-based integrated health maintenance organization system implemented a specialty drug benefit to manage expensive specialty drug costs. OBJECTIVES: Our objective was to measure and compare the change in adherence and persistence after implementation of copayment increases for select specialty medications used on a long-term basis (at least 2 years). METHODS: Patients who were long-term users of anti-inflammatory, immunosuppressant, cancer, and multiple sclerosis medications were selected. The intervention group consisted of those whose out-of-pocket payment for specialty medications increased, and the control group consisted of those whose out-of-pocket costs did not change. Adherence, defined by proportion of days covered, was measured every 3 months for 12 months before and after the change. Individual growth model analysis evaluated the changes in adherence. Cox regression analysis determined the difference in persistence between groups. RESULTS: There were 178 and 202 patients in the intervention and control groups, respectively. The growth model showed a small but statistically significant decrease in proportion of days covered of 0.040 after copay changes in the intervention versus control group (P < 0.001) for immunosuppressants. The Cox regression analysis indicated a higher probability of intervention patients on anti-inflammatory drugs (hazard ratio [HR] = 2.53; 95% CI, 1.38-4.62) and immunosuppressants (HR = 3.01; 95% CI, 1.20-7.56) would be nonpersistent compared with those in their control groups. CONCLUSIONS: The move to the specialty formulary allows for closer scrutiny of specialty utilization by pharmacists, who actively monitor utilization and access. Despite the minimal adherence decrease and significant persistence changes with certain drug types, the results indicated relatively more stability with specialty drug use than reported with traditional pharmaceuticals.

Assessing the readiness of black churches to engage in health disparities research.

We assessed church readiness to engage in health disparities research using a newly developed instrument, examined the correlates of readiness, and described strategies that churches used to promote health. We pilot tested the instrument with churches in a church-academic partnership (n = 12). We determined level of readiness to engage in research and assessed correlates of readiness. We also conducted interviews with participating pastors to explore strategies they had in place to support research engagement. Churches scored fairly high in readiness (average of 4.04 out of 5). Churches with a pastor who promoted the importance of good nutrition in a sermon or had a budget for health-related activities had significantly higher readiness scores than churches without such practices. Having a tool to evaluate church readiness to engage in research will inform targeted technical assistance and research projects that will strengthen church-academic partnerships and improve capacity to address health disparities.

Preoperative tyrosine kinase inhibition as an adjunct to debulking nephrectomy.

OBJECTIVES: Since the introduction of tyrosine kinase inhibitors (TKI), treatment of metastatic renal cell carcinoma (RCC) has undergone dramatic changes. However, the use of TKI therapy in adjunctive settings remains to be defined. We present a single-institution experience of patients who received preoperative TKI before nephrectomy for metastatic or unresectable disease. METHODS: The records of 9 patients with locally advanced or metastatic RCC treated with TKI therapy before nephrectomy at the University of North Carolina were reviewed. All procedures and radiographic images were performed at 1 institution. The cases were surveyed for the effect of TKI on tumor burden and surgical approach and timing. RESULTS: The patients received systemic therapy with either sorafenib or sunitinib before proceeding to nephrectomy on clinical trials for metastatic disease or as the standard of care. The surgery was well tolerated by all patients, without an apparent effect from TKI therapy on the surgical technique or complications. Responses were observed in the primary tumor, as well as in the metastatic sites. CONCLUSIONS: Neoadjuvant TKI therapy can induce responses in the primary tumor and has the potential advantage of cytoreduction when administered before nephrectomy for RCC. This setting also potentially provides an opportunity to evaluate the TKI responsiveness of patients with metastatic disease. However, prospective trials evaluating adjunctive surgical approaches to locally advanced and metastatic RCC are needed to determine the significant benefits of TKI therapy and to define the optimal agent, timing of therapy, and disease stage to derive benefit for preoperative therapy.