Dinutuximab in adult-onset chemotherapy refractory high-risk neuroblastoma.

INTRODUCTION: Neuroblastoma is the most common extracranial solid tumor in pediatrics but is considerably uncommon in adults, with approximately 1 case per 10 million diagnosed per year and is associated with poor prognosis. There are no standard treatment protocols for adult-onset neuroblastomas and there are only a few published case reports on neuroblastoma in adults. CASE REPORT: We report our treatment experience in a 41-year-old female diagnosed with high-risk, poorly differentiated neuroblastoma. MANAGEMENT AND OUTCOME: Our patient received two cycles of dinutuximab adapted from the Children's Oncology Group ANBL1221 protocol. The patient experienced pain, neuropathy, pruritus, and infusion reactions which were managed with supportive care. Due to the lack of tumor regression, dinutuximab was omitted from future treatments. Currently, the patient is asymptomatic from her disease and remains off of all therapy and pain medication. DISCUSSION: While dinutuximab has produced promising outcomes in pediatric patients, it is not without potentially severe adverse effects. Serious reactions of capillary leak syndrome, infusion reactions, pain, and neuropathy have been reported. Clinicians must be cognizant of the treatment-related toxicities associated with dinutuximab therapy, ranging from pain, neuropathy, pruritus, and infusion reactions as explored in this patient case.

Heparin versus enoxaparin for prevention of venous thromboembolism after trauma: A randomized noninferiority trial.

BACKGROUND: Research comparing enoxaparin with unfractionated heparin (UFH) given every 12 hours for venous thromboembolism (VTE) prophylaxis after trauma overlooks original recommendations that UFH be given every 8 hours. We conducted a prospective, randomized, noninferiority trial comparing UFH every 8 hours and standard enoxaparin every 12 hours. We hypothesized that the incidence of VTE in trauma patients receiving UFH every 8 hours would be no more than 10% higher than that in patients receiving enoxaparin every 12 hours. METHODS: Trauma patients who met criteria for VTE prophylaxis at a Level I trauma center were randomly assigned to 5,000-U UFH every 8 hours or 30-mg enoxaparin every 12 hours between November 2012 and September 2014. Surveillance duplex ultrasound was performed twice weekly on intensive care unit patients and weekly on ward patients. Primary end points were deep vein thrombosis diagnosed by duplex ultrasound and pulmonary embolism diagnosed by computed tomography angiography. RESULTS: Of 495 randomized patients, 220 received UFH and 216 received enoxaparin for analysis. Overall, 105 in the UFH group and 103 in the enoxaparin group underwent VTE surveillance or diagnostic testing. In the analysis of randomized patients who received treatment, UFH was noninferior compared with enoxaparin (absolute VTE risk difference, 3.1%; 95% confidence interval, -1.6% to 7.7%; p = 0.196); however, in the screening ultrasound group, the noninferiority of UFH was inconclusive (absolute VTE risk difference, 6.5%; 95% confidence interval, -2.9% to 15.8%; p = 0.179). The two treatments did not differ with regard to adverse events. The pharmaceutical cost for the regimen of UFH ($2,809) was nearly 20-fold lower than that for enoxaparin ($54,138). CONCLUSION: A regimen of UFH every 8 hours may be noninferior to enoxaparin every 12 hours for the prevention of VTE following trauma. Given UFH's cost advantage, the use of UFH for VTE prophylaxis may offer greater value. LEVEL OF EVIDENCE: Therapeutic/care management study, level II.

Cost analytic model to determine the least costly inpatient erythropoiesis stimulating therapy regimen.

BACKGROUND: Unlike in outpatient settings, the comparative costs of epoetin alpha (EPO) and darbepoetin alpha (DARB) have not been evaluated broadly from the inpatient hospital perspective. OBJECTIVE: To develop a cost analytic model comparing hospital inpatient costs for erythropoiesis stimulating therapies within the nephrology and oncology settings. METHODS: A cost analytic model incorporating erythropoietic drug, pharmacy, and nursing costs was developed from the inpatient hospital perspective to evaluate comparative costs of EPO and DARB. Erythropoietic drug costs were calculated using unit wholesale acquisition cost multiplied by the number of units or micrograms while comparing the following dosing regimens: EPO 3 times weekly, EPO once weekly, and DARB once weekly. Pharmacy costs included dispensing and delivery costs, while nursing costs incorporated administration time costs; all were calculated by estimated fractional hours per activity multiplied by hourly wages. The total frequency of erythropoiesis stimulating therapy administrations was determined based on the average hospital length of stay. The first erythropoiesis stimulating therapy dose was assumed to occur on day 3 of hospitalization. For total inpatient costs, a weighted average was calculated across disease states. One-way sensitivity analyses were conducted by varying length of stay, day of initial erythropoiesis stimulating therapy dose, pharmacy and nursing costs, and once-weekly DARB dose. RESULTS: EPO 3 times weekly was the least costly regimen across all disease states evaluated. Threshold analysis indicated that the cost of once-weekly DARB regimens would have to be reduced by 37% to equal the cost of EPO 3 times weekly for an average length of stay. Sensitivity analyses did not considerably affect the results. CONCLUSIONS: EPO 3 times weekly was found to be the least costly erythropoiesis stimulating therapy regimen for nephrology and oncology inpatients for the average length of stay as well as most other lengths of stay considered. Once-weekly EPO was the least costly erythropoiesis stimulating therapy regimen for several other lengths of stay, while once-weekly DARB was never found to be the least costly regimen.