A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2- Metastatic Breast Cancer.

PIK3CA mutation frequency varies among breast cancer (BC) subtypes. Recent evidence suggests combination therapy with the PI3K inhibitor (PI3Ki) alpelisib and endocrine therapy (ET) improves response rates and progression-free survival (PFS) in PIK3CA-mutant, hormone receptor positive (HR+) BC versus ET alone; thus, better understanding the clinical and epidemiologic elements of these mutations is warranted. This systematic review characterizes the PIK3CA mutation epidemiology, type of testing approaches (e.g., liquid or tissue tumor biopsy), and stability/concordance (e.g., consistency in results by liquid versus solid tumor sample, by the same method over time) in patients with HR+/HER2- advanced (locally unresectable) or metastatic disease (HR+/HER2- mBC) and explores performance (e.g., pairwise concordance, sensitivity, specificity, or predictive value) of respective mutation findings. A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and select conference abstracts (i.e., AACR, ASCO, SABCS, ECCO, and ESMO conferences between 2014 and 2017) identified 39 studies of patients with HR+, HER2- mBC. The median prevalence of PIK3CA mutation was 36% (range: 13.3% to 61.5%); identified testing approaches more commonly used tissue over liquid biopsies and primarily utilized next-generation sequencing (NGS), polymerase chain reaction (PCR), or Sanger sequencing. There was concordance and stability between tissues (range: 70.4% to 94%) based on limited data. Given the clinical benefit of the PI3Ki alpelisib in patients with PIK3CA mutant HR+/HER2- mBC, determination of tumor PIK3CA mutation status is of importance in managing patients with HR+/HER2- mBC. Prevalence of this mutation and utility of test methodologies likely warrants PIK3CA mutation testing in all patients with this breast cancer subtype via definitive assessment of PIK3CA mutational status.

A Systematic Literature Review of the Prognostic and Predictive Value of PIK3CA Mutations in HR+/HER2- Metastatic Breast Cancer.

PIK3CA mutations may have prognostic value for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer, representing an important potential target for systemic therapy. Prognostic and predictive values associated with PIK3CA mutations are not well understood. A comprehensive search of PubMed/MEDLINE, EMBASE, Cochrane Central, and conference abstracts was performed for English-language articles published January 1993 through April 2019. Articles were categorized by treatment arms based on experimental and treatment drug classes. Information on progression-free survival (PFS), hazard ratios, overall survival, response rate, and clinical benefit rate was obtained. A total of 17 studies were included. Among those evaluating non-PI3Ki based therapies, 91% showed numerically shorter median PFS, ranging from 1.5 to 19.2 months and 1.8 to 29.6 months for the mutant versus non-mutant subgroups, respectively. Where reported (n = 13 studies), PFS was shorter between those arms offering endocrine monotherapy (range, 1.6-14.7 months) compared with a corresponding targeted therapy + endocrine monotherapy (range, 3.9-29.6 months). Of 5 PI3Ki-based arms comparing PFS, higher median PFS in PIK3CA mutant versus non-mutant cases was demonstrated. PFS was shorter for patients with PIK3CA mutant (range, 1.6-19.2 months) compared with PIK3CA wild-type (range, 1.8-29.6 months) in 10 (71%) of 14 treatment arms reporting PFS. Studies (n = 4) not reporting PFS reported response rate, but there were no clear directional trends. The presence of PIK3CA mutations may be associated with worse clinical outcomes in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. Clinical outcomes such as PFS may be improved using a combination of PI3Ki-based therapies and endocrine therapies among this population. However, more research is warranted to fully elucidate this association.

Smoking quit rates among patients receiving pharmacist-provided pharmacotherapy and telephonic smoking cessation counseling.

OBJECTIVES: Tobacco use is the nation's leading cause of preventable illness and death, causing a significant burden on the health care system. Many cessation pharmacotherapy treatment options are available to help smokers quit, including nicotine replacement therapies (NRTs) and prescription medications. Research indicates that pharmacists are able to provide a positive benefit to smokers who want to quit through pharmacologic and nonpharmacologic interventions. The aim of the present work was to examine the quit rates among participants who received smoking cessation pharmacotherapy and pharmacist-provided telephone-based quit counseling services. DESIGN: Retrospective database review of enrolled participants. SETTING: Telephone-based pharmacotherapy and medication counseling services offered from a medication management center. PARTICIPANTS: State employees who voluntarily contacted a medication management center for smoking cessation services after receiving promotional flyers. MAIN OUTCOME MEASURES: Long-term quit rates at 7 and 13 months were determined by means of patient self-report in response to questioning. Smoking cessation was considered to be a success if the patient reported not smoking for the past 30 days. RESULTS: A total of 238 participants were included in the review. Thirty-nine participants completed the program after the first treatment, 12 participants after the second treatment, and 4 participants after the third treatment. Two patients completed the program more than once. Eighty-five participants (36%) reported results at 7-month follow-up; of these, 43 (51%) were smoking free. A total of 44 participants (18%) reported results at 13-month follow-up; of these, 24 participants (55%) reported being smoking free. There were no significant differences in the percentages of smoking-free participants at 7 or 13 months, regardless of their first treatment (P = 0.06 and 0.345, respectively). CONCLUSION: Successful quit rates were higher than previously demonstrated with other telephone-based smoking cessation programs. Therefore, pharmacist-provided telephone-based counseling may be beneficial in helping patients to quit smoking. Future research is warranted to examine the benefits of these types of programs.

Relationship Between Patients' Perceptions of Care Quality and Health Care Errors in 11 Countries: A Secondary Data Analysis.

Patients may be the most reliable reporters of some aspects of the health care process; their perspectives should be considered when pursuing changes to improve patient safety. The authors evaluated the association between patients' perceived health care quality and self-reported medical, medication, and laboratory errors in a multinational sample. The analysis was conducted using the 2010 Commonwealth Fund International Health Policy Survey, a multinational consumer survey conducted in 11 countries. Quality of care was measured by a multifaceted construct developed using Rasch techniques. After adjusting for potentially important confounding variables, an increase in respondents' perceptions of care coordination decreased the odds of self-reporting medical errors, medication errors, and laboratory errors (P < .001). As health care stakeholders continue to search for initiatives that improve care experiences and outcomes, this study's results emphasize the importance of guaranteeing integrated care.

Assessing the effect of providing a pharmacist with patient diagnosis on electronic prescription orders: a pilot study.

BACKGROUND: As a result of the US Omnibus Reconciliation Act of 1990 (OBRA '90), pharmacists have the obligation to ensure that prescription orders are appropriate and are not likely to cause adverse events. However, patient diagnosis information is not a requirement for a legal prescription order in any state in the US. OBJECTIVE: To compare a pharmacist's interventions before and after patient diagnosis is added by prescribers to their electronic prescription orders. METHODS: This prospective, pre-post study was conducted during two consecutive 4-week periods in a community health center pharmacy. During the first data collection period, the clinical pharmacist prospectively evaluated e-prescriptions using a standard DUR protocol. All problematic prescriptions were documented using a medication intervention form. During the second data collection period, providers included the patient's diagnosis on each e-prescription and the same clinical pharmacist again evaluated prescribed therapy and documented interventions. RESULTS: Pharmacist intervention rates on e-prescription orders were significantly lower following addition of the patient diagnosis information to the e-prescription order (3.9% pre- vs. 1.0% post-, P < 0.001). CONCLUSIONS: While preliminary, the results of this pilot suggest that the addition of patient diagnosis to the e-prescription order can reduce confusion and uncertainty on the part of a DUR pharmacist, thereby decreasing the overall number of interventions and the subsequent number of contacts with prescribers.

A cost-effectiveness evaluation of hospital discharge counseling by pharmacists.

OBJECTIVES: This study estimated the cost-effectiveness of pharmacist discharge counseling on medication-related morbidity in both the high-risk elderly and general US population. METHODS: A cost-effectiveness decision analytic model was developed using a health care system perspective based on published clinical trials. Costs included direct medical costs, and the effectiveness unit was patients discharged without suffering a subsequent adverse drug event. A systematic review of published studies was conducted to estimate variable probabilities in the cost-effectiveness model. To test the robustness of the results, a second-order probabilistic sensitivity analysis (Monte Carlo simulation) was used to run 10 000 cases through the model sampling across all distributions simultaneously. RESULTS: Pharmacist counseling at hospital discharge provided a small, but statistically significant, clinical improvement at a similar overall cost. Pharmacist counseling was cost saving in approximately 48% of scenarios and in the remaining scenarios had a low willingness-to-pay threshold for all scenarios being cost-effective. In addition, discharge counseling was more cost-effective in the high-risk elderly population compared to the general population. CONCLUSION: This cost-effectiveness analysis suggests that discharge counseling by pharmacists is quite cost-effective and estimated to be cost saving in over 48% of cases. High-risk elderly patients appear to especially benefit from these pharmacist services.