Comparison of Patient Outcomes With Two Different Formulations of Melphalan as Conditioning Chemotherapy for Autologous Hematopoietic Cell Transplantation in Multiple Myeloma.

BACKGROUND: High-dose melphalan (HDM) with autologous hematopoietic cell transplantation (AHCT) after induction chemotherapy is considered standard of care in transplant-eligible patients with newly-diagnosed multiple myeloma (MM). Alkeran melphalan has propylene glycol as a solvent (PG-mel) while Evomela utilizes a propylene glyclol-free formulation (PGF-mel). We evaluated the differences in efficacy and safety of the 2 formulations as there are no prospective head-to-head trials. METHODS: We retrospectively reviewed the medical records of all 259 consecutive MM patients who received PGF-mel as part of HDM-AHCT at The Ohio State University (OSU). The comparator group was the preceding 255 patients who received PG-mel. RESULTS: Baseline patient characteristics were similar between the 2 groups. Post-AHCT rates of relapse were comparable in the PG-mel and PGF-mel groups. Some adverse events were observed at a higher frequency in the PG-mel group compared to the PGF-mel group (grade ≥ 2 mucositis, febrile neutropenia, other infectious complications, and acute renal insufficiency). Time to neutrophil engraftment was slightly longer in the PG-mel group while time to platelet engraftment was longer in PGF-mel group. Red cell transfusion requirement was higher with the use of PG-mel but not platelet transfusion. Duration of hospitalization was slightly shorter with PGF-mel but readmission rates within 30 days of discharge were higher. CONCLUSION: Considering possible confounding factors could possibly account for observed differences in some adverse events, the comparable treatment responses, and difference in cost of the 2 formulation, The OSU reverted to PG-mel as the preferred formulation for HDM-AHCT in MM.

Development and Implementation of an Oral Oncology Drug Repository Program.

PURPOSE: Because of high costs associated with oral oncology drugs, patients are often unable to afford their medications. Developing and implementing an oral oncology drug repository program can provide cost savings and waste reduction opportunities to oncology patients and health care systems. METHODS: Strategies to implement an oral oncology drug repository program include the following: (1) define patient eligibility requirements for the collected drug, (2) ensure patients have long-term availability to preferred treatment, (3) identify optimal oral oncology drugs to use, (4) provide safe drug collection with protocol, (5) calculate the amount of resources needed to provide services, (6) obtain adequate space to operate safely and efficiently, (7) establish safe disposal of the drug deemed inappropriate for use, and (8) spread awareness to prospective patient participants. RESULTS: To date, The Ohio State University Wexner Medical Center oral oncology drug repository program has received 11 drug collections and has redispensed drugs several times. With additional resources, the plan is to expand the repository program's scope to include other drugs and reach more patients. CONCLUSION: Developing and implementing an oral oncology drug repository program for patients was logistically feasible due to strategic planning with many early successes. As national attention continues to be placed on reducing oral oncology drug costs, additional research is needed regarding strategies to best incorporate pharmacy services into innovative patient care opportunities.

Managing Immuno-Oncology Toxicity: Top 10 Innovative Institutional Solutions.

Expanded use of immuno-oncology (IO) therapy to treat cancer has led to an increased frequency of novel toxicities known as immune-related adverse events (irAEs). Delayed recognition of IO toxicity can be life-threatening or even fatal. To address this issue, intervention is possible at three levels: patients, medical providers, and institutions. Patients and the medical community need institutional safeguards in place to promote swift recognition, assessment, and treatment of IO toxicity. Patients receiving IO therapy must be educated to identify the drugs they have received and to recognize potential IO toxicity, and they must know how to report symptoms. Medical providers must be able to reliably identify that patients have received IO therapy as well as recognize rare or subtle symptoms of IO toxicity. Institutions can establish guidelines and order sets to standardize the treatment of patients receiving IO therapy with irAEs, including the complex management of steroid-refractory irAEs. Additional interventions at an institutional level include identification of IO toxicity champions (subspecialists with expertise in IO toxicity), creating immunotherapy-specific tumor boards and lecture series to educate clinicians and staff, and establishing research programs to evaluate IO toxicity. IO therapy and toxicity experiences must be published and shared with both oncology and nononcology providers in the local, national, and international medical community. These efforts aim to improve patient-related outcomes, increase provider education and awareness, and build institutional safety standards for our oncology patients.

Tocilizumab as first-line therapy for steroid-refractory acute graft-versus-host-disease: analysis of a single-center experience.

Acute graft-versus-host-disease (aGVHD) is a complication after allogeneic stem cell transplant. After the failure of treatment with high dose corticosteroids, steroid-refractory aGVHD (SR aGVHD) is associated with high rates of mortality. Tocilizumab has evidence of activity in SR aGVHD. For patients ineligible for trials, the OSU James Comprehensive Cancer Center has been utilizing tocilizumab as first-line therapy for SR aGVHD. We retrospectively report on 15 patients who received tocilizumab. aGVHD grading and responses were based on consensus criteria. Median age at transplant was 49 years. Median time to tocilizumab administration was 9 days (range, 3-16). Six patients had complete responses (40%) with a resolution of aGVHD. From the last contact, median overall survival for responders was not yet reached vs. 31 days for non-responders (p = .0002). Patients with skin and/or GI aGVHD demonstrated the greatest benefit. Patients with liver aGVHD did not respond. Future studies are needed to evaluate tocilizumab prior to steroid failure.

Use of organism identification by 16S ribosomal RNA polymerase chain reaction to shorten antimicrobial length of therapy.

BACKGROUND: Organism detection by 16S ribosomal RNA (rRNA) PCR followed by amplicon sequencing identification may help guide antimicrobial treatment in culture-negative patients. The objectives of this study were to assess the effect of a positive versus negative 16S rRNA PCR on antibiotic length of therapy (LOT) and rate of antibiotic discontinuation. METHODS: Patients with a sterile site, direct-specimen 16S rRNA PCR negative, and suspected active infection were matched 1:1 with 16S rRNA PCR positive patients based on specimen site and retrospectively evaluated. RESULTS: Ninety patients were included (n=45 positive and negative). 16S rRNA PCR negative patients had shorter median LOT (33days [IQR 8-46] versus 43days [IQR 29-51], P=0.02). Antibiotics were discontinued more frequently in 16S rRNA PCR negative patients (38% versus 4%, P<0.01). CONCLUSIONS: For culture-negative patients with suspected sterile site infection, a negative, direct-specimen 16S rRNA PCR may help discontinue antibiotics and decrease LOT.

Student Preparation for PGY1 Residency Training by US Colleges of Pharmacy: Survey of the Residency Program Director Perspective.

Purpose: To evaluate current residents' level of preparation by US colleges of pharmacy for postgraduate year 1 (PGY1) residency training from the perspective of residency program directors (RPDs). Methods: RPDs were asked in an electronic survey questionnaire to rate PGY1 pharmacy residents' abilities in 4 domains: communication, clinical knowledge, interpersonal/time-management skills, and professionalism/leadership. Results: One hundred ninety-seven RPDs of the American Society of Health-System Pharmacists (ASHP)-accredited PGY1 programs completed the survey. The majority of RPDs strongly agreed or agreed that residents were prepared as students to effectively communicate both verbally and nonverbally, were able to appropriately respond to drug inquiries using drug resources and literature searches, and consistently displayed professionalism. Respondents were more likely to disagree or give a neutral response when asked about residents' understanding of biostatistics and their ability to provide enteral and parenteral nutritional support for patients. Conclusion: Overall, RPDs agreed that residents were prepared to perform the majority of the tasks of each of the 4 domains assessed in this survey relating to PGY1 training. RPDs may use the results of this survey to provide additional support for their residents in the areas in which residents lack adequate preparation, while colleges of pharmacy may focus on incorporating more time in their curriculum for certain areas to better prepare their students for residency training.