The impact of early versus late tocilizumab administration in patients with cytokine release syndrome secondary to immune effector cell therapy.

INTRODUCTION: Cytokine release syndrome is a life-threatening hyper-inflammatory state induced by immune effector cell therapy. Anti-interleukin 6-(IL-6) therapy, such as tocilizumab, is the standard treatment for cytokine release syndrome since it reverses symptoms without compromising immune effector cell therapy efficacy. Glucocorticoids are reserved for refractory or severe cytokine release syndrome due to concern for attenuating antitumor activity. Optimizing the timing of tocilizumab could avoid glucocorticoid use and improve outcomes. This study assesses tocilizumab timing on patient outcomes and healthcare resource utilization. METHODS: This is a retrospective single-institution analysis of 28 patients who received tocilizumab for cytokine release syndrome secondary to immune effector cell therapy. Patients were categorized into two groups: Early Tocilizumab (within 24 h) or Late Tocilizumab groups (more than 24 h) from fever onset. The composite primary endpoint was glucocorticoid use, intensive care unit admission, or inpatient mortality. Secondary outcomes include comparing the various presentations of cytokine release syndrome, need for vasopressors, length of stay, rates of neurotoxicity, and C-reactive protein and ferritin trends. RESULTS: The Early Tocilizumab group presented with more rapid fever onset (35 vs.113 h, P = 0.017) and higher maximum cytokine release syndrome grade (Median, Grade 2 vs. Grade 1, P = 0.025). Additionally, the Early Tocilizumab group required more doses of tocilizumab (Median, 2 vs. 1, P = 0.037). Despite the difference in cytokine release syndrome presentation, the primary composite endpoint was not statistically different between groups. CONCLUSION: Earlier onset of fever appears to be associated with more severe, progressive cytokine release syndrome requiring multiple doses of anti-interleukin-6 therapy. Prompt and aggressive tocilizumab treatment could be protective against the negative consequences of cytokine release syndrome.

Impact of a formal pharmacist-run oral antineoplastic monitoring program: A pilot study in an adult genitourinary oncology clinic.

BACKGROUND: In recent years, there has been a changing paradigm in the management of oncologic disease states from the use of intravenous therapies, requiring a visit to the infusion center or hospitalization, to new therapies that can be administered orally.1,2 Several publications have evaluated the role pharmacists may play in the initial prescribing of oral chemotherapy, however the impact of a formalized pharmacist follow-up program has not been well defined. This study evaluates the impact of a pilot pharmacist-run oral antineoplastic monitoring program. METHODS: This retrospective cohort analysis evaluated patients prescribed an oral antineoplastic in the genitourinary oncology clinic at an academic medical center between 1 July 2014 and 15 March 2017. Patients enrolled in the program were compared to a historical control group. The primary objective was adherence to pre-defined standards for monitoring. Secondary objectives include persistence on therapy, need to seek medical care, analysis of pharmacist interventions, patient satisfaction, and financial impact for the on-site retail pharmacy. RESULTS: In total, 33 patients were evaluated (11 cases, 22 controls). Average adherence to monitoring recommendations was significantly higher in the case group compared to controls (89% vs. 61%; p = 0.008). In total, 67 interventions were made by the clinical pharmacist with an average of 6 per patient. CONCLUSIONS: This study shows that formalized pharmacist follow-up programs can improve patients' adherence with antineoplastic monitoring standards. Additionally, pharmacists made clinically significant interventions and had high patient satisfaction, providing justification for expansion into other disease states.

Evaluation of the dosing strategies of biologic agents and the theoretical impact of dose rounding.

Introduction Monoclonal antibodies possess unique pharmacokinetic properties that permit flexible dosing. Increased use and high costs of these medications have led to the development of cost-containing strategies. This study aims to quantify the cost savings and clinical impact associated with dose rounding monoclonal antibodies to the nearest vial size. Methods This study was a single-arm, retrospective chart review assessing all monoclonal antibody doses dispensed at an outpatient community infusion center associated with an academic medical center between August 2014 and August 2015. All monoclonal antibody doses were reviewed to determine the cost of drug wasted using two methods. The waste-cost analysis described the amount of drug disposed of due to the use of partial vials. The theoretical dose savings described potential cost avoidance based on rounding the ordered dose to the nearest vial size. The theoretical rounded dose was compared to the actual ordered dose to explore clinical implications. Results A total of 436 doses were included. Of these, 237 were not rounded to the nearest vial size and included in the analysis. The cost of waste associated with these doses was $108,013.64 using actual wholesale price. The potential cost avoidance associated with the theoretical dose calculation was $83,595.53. Rounding these doses to the nearest vial size resulted in a median 6.7% (range, 1.4-20%) deviation from ordered dose. Conclusions Rounding monoclonal antibodies to the nearest vial size could lead to significant cost and waste savings with minimal deviation from the actual ordered dose.