Evaluation of appropriate use of bisphosphonates and denosumab in patients with cancer.

BACKGROUND: National guidelines recommend screening and treatment for cancer-related bone disease and continued monitoring of bone-modifying agents. It is unclear whether a standardized screening tool is utilized to identify eligible patients and ensure appropriate supportive care is implemented. The purpose of this study was to evaluate current prescribing practices and optimize management of bone-modifying agents. METHODS: A retrospective chart review was performed to identify patients who received hormone deprivation therapy or had bone metastases through Hematology/Oncology or Urology clinics from 1 November 2016 to 31 October 2017. The primary endpoints of this study were the incidence of completed baseline dual-energy X-ray absorptiometry (DEXA) scan for patients on hormone deprivation therapy and percent of patients started on a bone-modifying agent for the prevention of skeletal-related events secondary to bone metastasis. Secondary endpoints included percent of patients with dental examinations prior to initiation, adequate calcium and vitamin D supplementation, incidence of osteonecrosis of the jaw or flu-like symptoms and education, and percent of bisphosphonate doses appropriately adjusted based on renal function. RESULTS: A total of 375 patients were assessed for baseline DEXA scans and bone-modifying therapy. Of the 226 patients on hormone deprivation therapy, 111 (49%) patients were appropriately screened with a DEXA scan prior to initiation of hormone deprivation therapy. Among the 149 patients with bone metastases, only 94 (63.1%) patients were started on a bone-modifying agent. CONCLUSIONS: Opportunities have been identified to optimize management of patients with cancer-related bone disease. Implementation of standardized tools may increase the rate of appropriate screening and initiation of bone-modifying therapy when warranted.

Virtually there: An innovative approach for training oncology pharmacy residents in gynecologic oncology.

OBJECTIVE: To develop an alternative approach to provide oncology pharmacy practice residents' education and training in the management of gynecologic malignancies in the absence of a specialist in this area at their institution. SETTING: Gynecologic oncology is a unique specialty in oncology. There is a need for more oncology clinical pharmacy specialists to participate in the care of patients with gynecologic malignancies as many do not have specific education in this area. PRACTICE DESCRIPTION: A virtual learning experience was developed that included all aspects of a typical experience with the exception of direct patient care. Postgraduate year 2 oncology pharmacy residents from 3 different programs were included. PRACTICE INNOVATION: Although the number of oncology clinical pharmacy specialists who are subspecialized in gynecologic oncology has grown, it is difficult to find experienced preceptors in gynecology oncology. We set to offer a virtual learning environment for programs that did not have a dedicated or highly specialized pharmacist in this area. EVALUATION: A pre- and postlearning assessment of the resident's knowledge of gynecologic malignancies was administered. Each trainee independently completed a validated 20-question gynecologic oncology knowledge assessment tool before and again after completion of all sessions. Midpoint and end-of-experience evaluations were completed via the phone with each resident. All evaluations were documented in PharmAcademic (McCreadie Group, Ann Arbor, MI), a required software program for postgraduate residency training programs. RESULTS: To date, 7 oncology pharmacy practice residents completed the virtual experience. A 42% improvement in scores pertaining to gynecologic oncology knowledge was identified. Residents were also satisfied with the overall virtual experience. Based on the assessment tool, all the residents gave positive evaluations with "always true" for 6 of the 7 questions. CONCLUSIONS: This pilot of a virtual experience was a successful platform to provide clinical knowledge and skills for oncology pharmacy residents in gynecologic oncology.

Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy.

PURPOSE: Nausea and vomiting are among the most feared complications of chemotherapy reported by patients. The objective of this study was to establish the overall complete response (CR; no emesis or use of rescue medication 0-120 h after chemotherapy) with either ondansetron- or palonosetron-containing antiemetic regimens in patients receiving highly emetogenic chemotherapy (HEC). METHODS: This was a prospective, open-label, randomized, single-center, pilot study that enrolled patients receiving their first cycle of HEC. Patients were randomized to receive either palonosetron 0.25 mg IV (PAD) or ondansetron 24 mg orally (OAD) on day 1 prior to HEC. All patients received oral aprepitant 125 mg on day 1, then 80 mg on days 2 and 3, and oral dexamethasone 12 mg on day 1, then 8 mg on days 2, 3, and 4. Descriptive statistics were used to summarize the data. RESULTS: A total of 40 patients were enrolled, 20 in each arm. All patients were female, and 39 received doxorubicin/cyclophosphamide chemotherapy for breast cancer. For the primary endpoint, 65 % (95 % CI, 40.8-84.6 %) of patients in the PAD arm and 40 % (95 % CI, 19.1-63.9 %) of patients in the OAD arm achieved an overall CR. CONCLUSIONS: While CR rates for aprepitant and dexamethasone plus palonosetron or ondansetron-containing regimens have been published previously, this is the first documentation of CR rates with these regimens in the same patient population. These results may be used to design a larger, adequately powered, prospective study comparing these regimens.

Serum free light chains in myeloma patients with an intact M protein by immunofixation: potential roles for response assessment and prognosis during induction therapy with novel agents.

The ascertainment of serum free light chain (sFLC) levels has been shown to be valuable in screening for the presence of plasma cell dyscrasia as well as for baseline prognosis in newly diagnosed patients. For patients with amyloidosis and those with oligo-secretory or non-secretory multiple myeloma (MM), serial measurement of sFLC has also been shown to be valuable in monitoring disease status. However, in patients with a measureable, intact monoclonal protein by immunofixation (M protein), the serial measurement of sFLC remains undefined and is currently not recommended in professional guidelines. Herein, we provide data comparing sFLC with M protein as biomarkers of response in newly diagnosed patients with MM undergoing induction therapy with the novel agents thalidomide, lenalidomide and/or bortezomib. We show that although M protein appears to outperform sFLC comparatively over the course of induction therapy, the addition of FLC to M protein further informs the characterization of residual disease status post-induction. Moreover, sFLC at the time of stem cell mobilization appears to hold prognostic power for survival endpoints following high-dose chemotherapy/autologous stem cell transplant (HDC/SCT). These findings suggest potentially novel roles for sFLC in patients with MM with an intact M protein receiving novel agent-based induction strategies followed by HDC/SCT.

Impact of an Oral Antineoplastic Renewal Clinic on Medication Possession Ratio and Cost-Savings.

PURPOSE: The primary objective of this study was to evaluate the impact of a pharmacist-driven oral antineoplastic (OAN) renewal clinic on medication adherence and cost savings. METHODS: This was a preimplementation and postimplementation retrospective cohort evaluation within a single US Department of Veterans Affairs health care system following implementation of a pharmacist-managed OAN refill clinic. The primary outcome was medication adherence defined as the median medication possession ratio (MPR) before and after implementation of the clinic. Secondary outcomes included the proportion of patients who were adherent from pre- to postimplementation and estimated cost-savings of this clinic. Patients were eligible for inclusion if they had received at least 2 prescriptions of the most commonly prescribed oral antineoplastic agents at the institution between September 1, 2013 and January 31, 2015. RESULTS: Of preimplementation patients, 96 of 99 (96.9%) were male and all patients (n = 35) in the postimplementation group were male. The mean age of the preimplementation group was 69.2 years while the postimplementation group was 68.4 years. Median MPR in the preimplementation group was 0.94, compared with 1.06 in the postimplementation group (P < .001). Thirty-six (36.7%) patients in the preimplementation group were considered nonadherent to their OAN regimen compared with zero patients in the postimplementation group. Estimated total cost savings was $36,335 in the postimplementation period. CONCLUSIONS: Implementation of a pharmacist-driven OAN renewal clinic was associated with a 12% increase in median MPR while saving an estimated $36,335 during the 5-month postimplementation period.

Implementation and Evaluation of a 90-Minute Rituximab Infusion Protocol at the Richard L. Roudebush VA Medical Center.

BACKGROUND: The use of IV rituximab for the treatment of a variety of malignant and nonmalignant indications has been associated with significant challenges related to time and labor. To help alleviate some of these logistic challenges, institutions have implemented protocols to shorten the time in which rituximab is infused. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center (RLRVAMC). METHODS: A 90-minute rituximab protocol was developed, and proactive measures were taken to educate physicians, pharmacists, and nurses on ordering, processing, compounding, and administering rituximab. A weekly report of patients who received rituximab at RLRVAMC was generated November 1, 2018 through April 1, 2019. Patients then were screened for rapid infusion of the drug based on eligibility criteria, and health care providers (HCPs) were notified. After each patient received a rapid infusion, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns that would require protocol modification. The primary endpoint for this study was the incidence of grade 3 and 4 infusion-related reactions (IRRs) associated with rapid infusions of rituximab based on the Common Terminology Criteria for Adverse Events Version 5.0. RESULTS: Eleven patients received 24 rapid infusions of rituximab. Of these infusions, 1 (4.2%) resulted in a grade 3 IRR; no infusions resulted in a reaction of grade ≥ 4. The use of rapid infusion of rituximab when compared with nonrapid infusion saved 39.3 minutes on average per patient. CONCLUSIONS: The proactive measures that were used to implement the rapid infusion rituximab protocol improved HCP prescribing rates, nursing satisfaction, and the management of IRRs. This study confirmed appropriateness of rapid administration of rituximab in this veteran population and has increased interest in implementing other rapid infusion protocols.

Extended use of intravenous bisphosphonate therapy for the prevention of skeletal complications in patients with cancer.

PURPOSE: To evaluate the incidence of skeletal complications in patients with multiple myeloma, and metastatic breast, prostate, or lung cancers, when therapy with intravenous bisphosphonates is continued for longer than 21 months. METHODS: The primary outcome was the diagnosis of at least one skeletal-related event (SRE) after 21 months of therapy. The secondary outcome was the incidence of osteonecrosis of the jaws (ONJ). RESULTS: The primary outcome was 30%. The secondary outcome was 3%, while six patients (5%) were referred to a dentist for suspected ONJ. CONCLUSION: There appears to be a continued benefit when intravenous bisphosphonates are given for longer than 21 months.

Once-weekly vancomycin for patients receiving high-flux hemodialysis.

PURPOSE: The effectiveness of a once-weekly vancomycin dosing protocol for patients receiving long-term high-flux hemodialysis (HFHD) in the outpatient setting was studied. METHODS: Eligible patients were at least 18 years old, required hemodialysis for at least two months before study enrollment, and were not known to have any active infection. All patients received outpatient dialysis at a 1000-bed urban teaching hospital three times per week through a high-flux synthetic dialyzer. All patients received vancomycin 35 mg/kg, rounded to the nearest 250 mg, administered during hemodialysis at a rate of 1 g/hr via an infusion pump and scheduled to end when the hemodialysis session was over. Vancomycin was infused either predialyzer or postdialyzer, and infusion pumps were used in patients who received vancomycin through the postdialyzer access port. Serum vancomycin levels were measured before the third hemodialysis session (study day 8) to evaluate the percentage of patients who maintained therapeutic vancomycin concentrations of >or=10 microg/mL. RESULTS: No patients achieved a vancomycin concentration of >or=10 microg/mL on study day 8 (mean serum concentration, 5.1 microg/mL). When patients were separated into two groups based on administration technique, six patients (83%) who received vancomycin predialyzer had undetectable vancomycin levels (<3.5 microg/mL) by study day 8 (n = 6). Patients who received vancomycin postdialyzer maintained a mean serum concentration of 6.4 microg/mL at day 8 (n = 3). CONCLUSION: A single dose of vancomycin 35 mg/kg administered during HFHD in oliguric patients with end-stage renal disease did not achieve the therapeutic serum concentration necessary for once-weekly dosing.