2025 Southeastern Residency Conference

Title: THE USE OF LEVOCARNITINE AND VITAMIN B IN ADULT PATIENTS WITH ACUTE LYMPHOBLASTIC LUKEMIA RECEIVING PEGASPARGASE


Authors: Veronica Bekheit, Caralyn Escobar, Hunter Burnstine, Stephen Tomasek


Background: Pegaspargase, a key component in the treatment of acute lymphoblastic leukemia (ALL), is associated with significant toxicities, including hepatoxicity, which can impact treatment tolerance and outcomes. Levocarnitine and vitamin B supplementation have been proposed as potential adjuncts to mitigate these adverse effects. This study aims to describe the utilization patterns of levocarnitine and vitamin B in adult patients with ALL receiving pegaspargase and assess trends in patient outcomes. 

Methods: A retrospective, descriptive analysis was conducted on adult patients ≥18 years old diagnosed with ALL who received pegaspargase as part of their chemotherapy regimen. Patient demographics, liver function test results, pancreatic liver enzyme levels, and levocarnitine and vitamin B supplementation regimens were gathered through a retrospective chart review. Trends in laboratory values before and after supplementation were analyzed.

Results: The group receiving both levocarnitine and vitamin B experienced a higher number of mild hepatotoxicity cases (Grades 1–2); however, instances of severe toxicity (Grades 3–4) were still observed. The use of levocarnitine and vitamin B may help maintain liver enzymes (AST, ALT, ALP) and pancreatic markers (amylase, lipase) closer to baseline levels. This suggests a potential role in reducing the severity of treatment-related toxicities.

Conclusion: Levocarnitine and vitamin B supplementation may help maintain normal liver and pancreatic enzyme levels during pegaspargase therapy. This approach shows potential to reduce treatment-related toxicities and may serve as a low-risk supportive care strategy for similar patient populations at other institutions.

Title: Assessment of Biomarker Testing in Hormone Receptor-Positive and Human Epidermal Growth Factor 2 Receptor-Negative Breast Cancer Patients 
Authors: Sarah Seward, Thomas Morris, Alexia Greene 
Background: Biomarkers are molecules within the body used to guide treatment of diseases. Genetic biomarkers can help predict the response to cancer therapy. Studies have shown inadequate utilization of biomarker testing despite high prevalence of mutations and significant improvements in clinical outcomes with targeted therapy. Previous literature supports the use of biomarker testing based on improved patient outcomes and suggests the need for improvement in routine clinical testing. The aim of this study is to assess the utilization of biomarker testing in accordance with guideline recommendations for ESR1, AKT1, PIK3CA, and BRCA mutations in endocrine-resistant metastatic breast cancer patients.   
Methods: This study was a retrospective, observational, cohort study utilizing electronic medical records. Data collection included FirstHealth Cancer Center patients between January 1st, 2023, and December 31st, 2023. Patients were included by the following criteria: 18 years of age or older, female, and with HR+, HER2- metastatic breast cancer. Exclusion criteria include

Title: Effect of Standard vs. Rapid Infusion Oxaliplatin on Neuropathy and Patient Outcomes in Colorectal Cancer


Authors: Sara Niazi, PharmD; Matthew Zakhari, PharmD; Courtney Mallon, PharmD, BCOP; Stephen Aiken, PharmD, BCOP


Objective: The purpose of this study is to assess the impact of oxaliplatin infusion rate on incidence of early oxaliplatin discontinuation due to neuropathy and patient outcomes in colorectal cancer.


Self Assessment Question:
Which is a well-known side effect of oxaliplatin treatment, sometimes leading to discontinuations/dose reductions of the medication?

1. Cardiac toxicity
2. Hyperglycemia
3. Rash
4. Peripheral Neuropathy

Background: National Comprehensive Cancer Network guidelines state oxaliplatin may be administered at 1 mg/m²/min in gastrointestinal-related malignancy treatment regimens, based on results by Cercek et al. in 2016. A study in 2023 by Huynh et al. found increased incidence of peripheral neuropathy and oxaliplatin discontinuation with rapid compared with standard-rate oxaliplatin infusions. There is a lack of studies evaluating patient outcomes secondary to early discontinuation of oxaliplatin associated with rapid-infusion rates.


Methods: This was a retrospective chart review of adult patients receiving oxaliplatin at the standard-infusion vs. rapid-infusion rate at a single institution academic medical center from January 2016 - December 2024. The primary endpoint was incidence of early oxaliplatin discontinuation due to neuropathy. Secondary outcomes included incidence of oxaliplatin dose reductions due to neuropathy and time to progression after starting an oxaliplatin-containing regimen. Patients were included if they received an oxaliplatin-containing regimen for colorectal cancer. Patients were excluded if they were treated with >1 active chemotherapy regimen, in a vulnerable population, and had a clearly documented transition of care to a different facility.  


Results: The percentage of patients with colon cancer studied was higher than those with rectal cancer in both the standard infusion rate (66.9% and 33.1%, respectively) and the rapid infusion group (70.5% and 29.5%, respectively). The distribution of cancer regimens used in the rapid vs standard infusion groups was similar, with the most common being mFOLFOX6 (74.7% in the standard rate group and 91.7% in the rapid rate group). Rapid rate oxaliplatin was not associated with a statistically significant increase in incidence of oxaliplatin discontinuation due to peripheral neuropathy compared to standard-rate oxaliplatin, (23.7% versus 16.5%, p = 0.11). There was a difference between the percentage of dose reductions due to peripheral neuropathy between the rapid infusion rate and the standard-rate (18.7% versus 10.1%, p = 0.03). There was no significant difference in documented disease progression between the rapid versus standard-rate oxaliplatin (32.7% versus 34.8%, respectively, p = 0.69). 
 
Conclusion: There was a clinically but not statistically significant increase in incidence of oxaliplatin discontinuation due to peripheral neuropathy in the rapid infusion rate group compared to the standard infusion rate group. However, there was a clinically and statistically significant increase in the incidence of dose reductions due to peripheral neuropathy in the rapid compared to the standard rate oxaliplatin infusion groups. Further studies need to be done to include various races, a means to gather data that may not have been documented or available in the electronic medical record, and on a larger scale.

SAFETY AND EFFICACY OF IV FOSAPREPITANT VERSUS IV APREPITANT Ha Nguyen Trinh, Sajia Kotwal, Karishma Patel Emory Decatur Hospital, Decatur, GA 
Background/Purpose: Chemotherapy-induced nausea and vomiting (CINV) remains a common and distressing side effect that can have a negative impact on the quality of cancer patients’ lives. Neurokinin-1 receptor antagonists (NK1RAs) effectively prevent CINV for moderate to high emetogenic chemotherapy regimens. The two most common NK1RAs are aprepitant and fosaprepitant. While IV fosaprepitant has been shown to be non-inferior to aprepitant, it is associated with a higher incidence of infusion-related adverse reactions (IRARs), compared to IV aprepitant. This occurs because IV fosaprepitant contains polysorbate 80, a surfactant known to increase the risk of hypersensitivity and IRARs. Both agents have been used for CINV prevention; however, IV fosaprepitant has recently become the preferred formulary NK1RA at our institution. This research project aimed to compare the safety and efficacy of IV fosaprepitant and IV aprepitant in patients who received chemotherapy inpatient and at the outpatient infusion center at Emory Decatur Hospital (EDH).  

Methods: This study was a single-center, retrospective analysis of 86 patients aged 18 years or older who received either IV fosaprepitant or IV aprepitant as part of the antiemetic regimen for CINV at EDH between October 2022 and August 2024. Patients who were intolerant to either agent, received either agent for indications other than CINV or received oral aprepitant were excluded. The primary outcome was the incidence of IRARs, characterized by injection site pain, swelling, erythema, phlebitis, thrombophlebitis, and hypersensitivity (e.g., hypotension or hypertension, dyspnea, bronchospasm, edema, blisters, rash, flushing, chills or fever). Secondary outcomes included CINV complete response (CR) rates in the acute phase (defined as the absence of vomiting and use of rescue medications within 24 hours), number of vomiting episodes, use of rescue medications for breakthrough emesis, incidence of discontinuation and the incidence of switching from one NK1RA to another NK1RA. Descriptive statistics were used to summarize baseline characteristics, primary and secondary outcomes. Continuous variables were reported as means +/- standard deviation or median with interquartile ranges, while categorical variables were expressed as frequencies and percentages. Primary and secondary outcomes were compared using odds ratio (OR), 95% confidence interval (CI), and p-value of 0.05. 

Results:  For the primary outcome, there were no incidences of infusion reactions in the IV aprepitant group but there were 5 (11.4%) incidences of infusion reactions in the IV fosaprepitant group (p = 0.025, OR = 11, 95% CI [0.6 - 205]). There was no significant difference in CINV CR rates between the two groups (p = 0.64, OR = 1.8, 95% CI [0.1 - 2.4]). No patients reported experiencing vomiting episodes. Both groups had low and similar incidences of the use of rescue medications or breakthrough nausea (p = 0.62, OR = 0.71, 95% CI [0.2 - 3.4]). There were 5 incidences of discontinuation or switching from fosaprepitant to aprepitant (p = 0.025, OR = 11, 95% CI [0.6 - 205]). 

Conclusions: Both IV fosaprepitant and IV aprepitant were effective in CINV prevention. However, IV fosaprepitant was associated with a higher incidence of infusion-related adverse reactions.

Title: Evaluation of Antibiotic Allergies in Patients Who Underwent a Desensitization to Determine if a Desensitization Would Still Be Clinically Indicated Today


Authors: Sydney C. Hunt, Joanna L. Stollings, Elizabeth J. Phillips, and Cosby A. Stone, Jr


Background: The creation of antibiotic allergy risk stratification tools has called into question whether many of the previously performed antibiotic desensitizations would still be clinically indicated today. The purpose of this study was to evaluate how many of the desensitizations performed due to penicillin, cephalosporin, and trimethoprim-sulfamethoxazole allergies could have been avoided if current risk stratification tools were utilized. 


Methods: A retrospective review was conducted to risk stratify the allergy labels of patients who underwent a penicillin, cephalosporin, or trimethoprim-sulfamethoxazole desensitization between January 1, 2016 to December 31, 2023 at a quaternary referral center. The primary outcome was the incidence of low-risk allergy labels based on validated risk stratification criteria. Secondary outcomes included desensitization success rate and possible cost avoidance had an oral challenge been performed instead of a desensitization for allergies meeting low-risk criteria. 


Results: A total of 25 desensitizations were included: 13 (52%) for a penicillin, 6 (24%) for a cephalosporin, and 6 (24%) for trimethoprim-sulfamethoxazole. The most common desensitization antibiotics were penicillin G (n = 7, 28%) and trimethoprim-sulfamethoxazole (n = 6, 24%), and the most common desensitization indication was bacteremia (n = 7, 28%). Overall, 7 (28%) allergies were categorized as being low-risk. Out of the 25 desensitizations, 23 (92%) were successfully completed. An estimated $73,711.68 in healthcare spending could have been avoided had an oral challenge been performed instead of a desensitization in the patients identified to have low-risk allergies.


Conclusions: Nearly on-third of the antibiotic desensitizations could have been avoided had current allergy risk stratification tools been utilized, leading to decreased healthcare costs and possible allergy de-labeling.

Title: Comparison of Dostarlimab to Pembrolizumab in Combination with Chemotherapy in Patients with Advanced or Recurrent Endometrial Cancer

Authors: Aaliyah Parchment, Stephen Tomasek, Sarah Gifford, Nhi Tran, Joann Gold

Background/Purpose: Carboplatin and paclitaxel, combined with either dostarlimab or pembrolizumab, are National Comphrehensive Cancer Network approved standard-of-care regimens for the first line treatment of stage III or IV or recurrent endometrial cancer. However, despite the widespread use of dostarlimab and pembrolizumab, no clinical studies have been conducted to directly compare these two agents head-to-head when combined with cytotoxic chemotherapy. The objective of this study is to compare the efficacy and safety of dostarlimab and pembrolizumab when used in conjunction with carboplatin and paclitaxel for the first-line treatment of patients with stage III or IV endometrial cancer and those experiencing their first recurrence of the disease.

Methodology: This study is a retrospective chart review conducted at AdventHealth to compare the impact of dostarlimab and pembrolizumab with concurrent chemotherapy. The study has received approval from the Institutional Review Board. Those included in the study are patients with advanced or recurrent endometrial cancer who have received dostarlimab or pembrolizumab in combination with carboplatin and paclitaxel within AdventHealth from August 1, 2022, to January 31, 2024. Patients included are women 18 years of age and older with historical confirmed diagnosis of primary stage III or IV endometrial cancer, or first recurrence of disease. Patients with more than one recurrence of endometrial cancer will be excluded. Data collection from the electronic medical record will include patient demographics (age, race), tumor characteristics (histology type, stage at diagnosis, microsatellite instability status/mismatch repair status), and any prior therapies.  

The primary outcome is rate of progression free survival (PFS), defined as the proportion of patients who remained alive and without disease
 progression. The secondary outcome is overall survival (OS), measured as the duration from the initiation of treatment to death from any cause. Safety outcomes will be evaluated by common side effects associated with immunotherapy. The primary, secondary, and safety outcomes will be analyzed by basic statistical analyses. 

Results: Baseline characteristics, including age, treatment history, and molecular profiles, were similar between groups. Median progression-free survival (PFS) was 144 days (95% CI, 106.58–181.42) in the dostarlimab group and 173 days (95% CI, 0.00–379.44) in the pembrolizumab group; this difference was not statistically significant (P = 0.656). No deaths occurred in the pembrolizumab group, limiting overall survival (OS) comparison. Adverse events occurred in all patients. Treatment interruptions were more frequent with pembrolizumab (20% vs. 5%, P = 0.034). Constipation (P = 0.027) and myalgia (P = 0.023) were significantly more common in the pembrolizumab group, while grade ≥3 anemia was more frequent in the dostarlimab group (P = 0.006).

Conclusion: Dostarlimab and pembrolizumab demonstrated similar PFS outcomes, with no significant differences observed. The absence of deaths in the pembrolizumab group limited OS comparisons. Pembrolizumab was linked to more frequent treatment delays and gastrointestinal and musculoskeletal adverse events, while dostarlimab was associated with a higher rate of severe anemia. Overall, both regimens had comparable safety profiles. Further investigation in larger cohorts is warranted to confirm these findings.

Presentation Objective: Identify clinical data comparing dostarlimab to pembrolizumab with chemotherapy in advanced endometrial cancer

Self-Assessment Question: 
Which of the following correctly describes the intervention arm of the RUBY trial for first-line therapy in advanced or recurrent endometrial cancer?
A. Pembrolizumab 200 mg + chemotherapy for 6 cycles q3w, followed by pembrolizumab 400 mg q6w
B. Dostarlimab 500 mg + chemotherapy for 6 cycles q3w, followed by dostarlimab 1000 mg q6w up to 3 years
C. Chemotherapy alone for 6 cycles
D. Dostarlimab 1000 mg q3w + chemotherapy, followed by pembrolizumab 400 mg

Title: IMPACT OF PHARMACIST-LED TRANSITIONS OF CARE SERVICES FOR PATIENTS DISCHARGING ON ORAL CHEMOTHERAPY


Authors: Nathan Park, Courtney Mallon, Ashley Mull


Objective: To determine the effect of pharmacist-led transitions of care services for patients discharging on oral chemotherapy at the University of Tennessee Medical Center.


Background:
Oral anticancer therapies have changed the course of therapy in a growing number of malignancies that have traditionally been managed with intravenous (IV) chemotherapy. The increasing use of oral anticancer therapies benefits patient convenience and quality of life. However, several challenges now exist for patients from medication procurement, adherence, and safe handling and administration of these agents. Pharmacists are uniquely trained to improve outcomes through increased medication adherence, patient knowledge, and drug monitoring. This study aims to determine the effect of pharmacist-led transitions of care (TOC) services for patients discharging on oral chemotherapy at the University of Tennessee Medical Center.


Methods:
This prospective, single-center, quality improvement initiative included adult patients being discharged from the inpatient oncology service who filled a prescription for an oral chemotherapy at the University of Tennessee Specialty Pharmacy from January 1^st, 2024 to October 1^st, 2024. The primary endpoint was the average number of interventions made by oncology pharmacists regarding oral chemotherapy prescribed at discharge. Interventions included in the study included: drug-drug interactions, drug-disease clarification, dosing adjustments (non-renal/hepatic/toxicity), toxicity adjustment, drug acquisition, renal adjustments, hepatic adjustments, and other interventions. Secondary endpoints were the average number of interventions made within 1 week of discharge and the length of time in days between the prescription being sent to the pharmacy and the patient receiving their medication. 


Results:
A total of 23 patients were included in the study. At time of discharge, a total of 10 interventions were made with the average number of interventions per patient being 0.43. Of the 10 interventions made at discharge, five of them were involving drug acquisition. At follow-up, four interventions were made for an average number of interventions per patient of 0.17. All follow-up interventions involved patient counseling. The average length of time for patients to receive their medication was 8.83 days with a median (IQR) time of 4 (6.5) days. 


Conclusion:
Pharmacists most frequently intervened at time of discharge with most interventions being related to drug acquisition. Follow-up calls resulted in fewer interventions, but all interventions involved patient counseling. The study supports the need for further pharmacist involvement with transitions of care services.

Title: Randomized, Blinded Study of Olanzapine 2.5mg versus 5mg in Quadruplet Prophylaxis of Nausea/Vomiting after High-Dose Melphalan for Autologous Transplantation (The FONDO-LOW Trial)


Authors: Hanh Tran, E. Behren Ketchum, Vamsi Kota, Amber Clemmons


Objective: This study aims to determine the optimal dose of olanzapine when added to triplet prophylaxis in preventing CINV while minimizing the risk of daytime sedation after high-dose melphalan for patients with multiple myeloma receiving auto-HCT.


Self Assessment Question: In the FONDO-LOW study, subjects were assessed for emesis episodes, nausea severity, and sedation severity over five consecutive days. Each day, they rated their nausea and sedation severity using a 4-point scale based on their experiences in the past 24 hours. (True)


Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and difficult to manage side effect. Olanzapine is an FDA-approved atypical antipsychotic that blocks multiple neuronal receptors involved in nausea/vomiting pathways. The FOND-O trial conducted at our institution by Clemmons and colleagues previously determined that adding olanzapine 10 mg to triplet prophylaxis (fosaprepitant, ondansetron, dexamethasone) improved CINV for patients undergoing high-dose chemotherapy for autologous stem cell transplantation (auto-HCT). Results from that trial led to the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines offering the olanzapine-based quadruplet regimen as an option for this population. Despite the high efficacy, several studies have shown that the 10 mg olanzapine dose may be associated with substantial daytime somnolence. Current NCCN guidelines recommend low-dose olanzapine of 5 mg or 2.5 mg if 10 mg or 5 mg, respectively, causes excessive sedation. Additionally, many transplant centers endorse utilizing lower doses to avoid the sedating effect of olanzapine. Despite the use of lower doses in practice, no publications have evaluated an optimal dose of olanzapine in reducing CINV and minimizing daytime sedation when added to standard triplet therapy for patients receiving high-dose melphalan for auto-HCT.


Methods: This is a single-center, prospective, randomized, double-blind study. Inclusion criteria are adult patients 18 years and older who receive high-dose melphalan 140-200 mg/m2 prior to auto-HCT. Patients will be randomized to receive encapsulated olanzapine 5 mg or 2.5 mg tablet orally on the day of high-dose melphalan and for three additional days post-chemotherapy in addition to standard triplet antiemetic prophylaxis consisting of an NK-1 receptor antagonist, ondansetron, and dexamethasone. Primary endpoint is percentage of patients achieving overall CINV complete response (CR), defined as no emesis and no more than mild nausea on 0-4 scale (0-none, 1-mild, 2-moderate, 3-severe), between the two olanzapine dosing groups. Secondary endpoints are complete protection (CR plus no breakthrough antiemetic use), total number of emetic episodes and breakthrough antiemetic doses, rate of study drug discontinuation, and incidence of no more than mild daytime sedation per patient report on the 4-point scale (none to severe). All outcomes will be reported in acute (chemotherapy day), delayed (four days after chemotherapy), and overall 5-day assessment periods. With an 80% power alpha of 0.05, 86 patients recruited for each arm to detect a 10% difference between groups. Hence, a total of 172 patients will be accrued for 3 years. Descriptive statistics are utilized to analyze patient demographics whereas Chi-square and t-test are used for primary and secondary outcomes.


Results: In Progress


Conclusion: In Progress

Title: Paclitaxel infusion reaction evaluation and prevention strategies at a large community hospital outpatient chemotherapy infusion center
 
Authors: Emma Pride1; Allison Bass1; Amanda Ouzts1; Melissa Strobel2; F. Joseph Kelly2
Pharmacy Department, Huntsville Hospital – Huntsville, Alabama1
Tennessee Valley Gynecologic Oncology – Huntsville, Alabama2
 
Purpose/Background: Paclitaxel, a widely used drug in the treatment of gynecologic malignancies, is associated with hypersensitivity reactions in an estimated 2-4% of patients, and infusion related reactions in around 27% of patients, despite pre-medications.  There are known risk factors for paclitaxel reactions including respiratory dysfunction, obesity (defined as a body mass index ≥ 25), no history of alcohol consumption, and postmenopausal status. Recent updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide new insights into managing infusion-related reactions and hypersensitivity reactions in this setting, yet practical applications remain limited for management and prevention. Utilizing this information and other literature, this study aimed to evaluate the incidence of paclitaxel reactions at a large outpatient infusion center and implement a process improvement initiative focused on optimizing infusion protocols and premedication timing to enhance patient safety and support continued use of first-line therapy.
 
Methodology: This single-center, IRB-approved, pre-post implementation study evaluated female patients aged ≥18 years with gynecologic malignancies who received 3-hour paclitaxel infusions at Huntsville Hospital’s outpatient infusion center. The pre-intervention group included 224 patients who received paclitaxel from February 1, 2022, to December 31, 2024. Data collected from the electronical medical record included demographic factors, known reaction risk factors, and premedication timing. A new paclitaxel titration protocol and modified premedication timing strategy were implemented starting February 3, 2025 through April 1, 2025. Post-intervention data included patients receiving paclitaxel beginning on that date, regardless of treatment cycle. The primary endpoint was the occurrence of any documented reaction to paclitaxel. 
 
Results: A total of 224 patients were included in the pre-implementation analysis, of whom 44 (19.6%) experienced a reaction to paclitaxel. Of these, 11 (25%) were classified as hypersensitivity reactions, 28 (63.6%) as infusion-related reactions, and 5 (11.4%) could not be clearly classified. Common risk factors identified included BMI ≥ 25 (n=156), with 23% of these patients experiencing a reaction. Additionally, 84% of patients who reacted had premedications administered ≥45 minutes before paclitaxel. Following the implementation of updated premedication timing and infusion titration protocols, no reactions were documented in the initial 43 post-implementation administrations across cycle 1, cycle 2, and subsequent cycles. 
 
Conclusion: Implementation of an updated paclitaxel infusion protocol—including more prompt administration of premedications, priming lines with paclitaxel rather than normal saline, and a modified titration schedule—was associated with a reduction in infusion-related and hypersensitivity reactions. While initial post-intervention data is promising, continued monitoring is warranted to confirm the long-term impact in a larger cohort. 

Title: Evaluating Iron Sucrose Discordance Among Patients Within  
Cone Health Outpatient Infusion Centers   


Authors: Jessica Robles, Yatin Patel


Objective: Evaluate the impact of transitioning iron sucrose administration to IV push on iron sucrose discordance and infusion reactions


Self-Assessment Question: True or False: The incidence of infusion reactions with iron sucrose 200 mg is similar between administration via IV push vs IVPB infusion.


Background: Discordance is defined as an inappropriate dose or timing of administration of intravenous (IV) iron based on institutional policies. Social drivers of health, which are nonmedical factors impacting health outcomes, likely play a role in IV iron discordance. Social drivers of health can be quantified through a social vulnerability index (SVI), which is a novel composite measure encompassing variables that correspond to key social drivers of health; however, SVIs have not been studied in the evaluation of iron discordance. The dosing schedule of IV iron products also likely contributes to discordance. Older-generation IV iron products require more frequent dosing and have a higher incidence of discordance, but these products continue to have high utilization due to payor coverage and lower cost per dose. Iron sucrose, an older-generation IV iron product, is Cone Health’s preferred IV iron product, therefore it is essential to continually optimize its use by the health-system. In response to the nationwide fluid shortage, Cone Health outpatient infusion centers transitioned the administration of iron sucrose 200 mg doses from an IV piggyback (IVPB) infusion to an IV push. The purpose of this study was to evaluate the impact of this transition on iron sucrose discordance.


Methods: This was an IRB-reviewed and exempt, multi-center, pre-post study which evaluated iron sucrose discordance over three-month periods in the pre- and post-intervention groups. Adults who received their prescribed course of iron sucrose within the study period at one of the ten Cone Health outpatient infusion centers were included. Patients who did not have a Federal Information Processing Standards (FIPS) code available were excluded. The primary outcome was the incidence of iron sucrose discordance. A treatment course was deemed discordant if the patient did not receive at least one gram of iron sucrose within a 14-day period. Secondary outcomes included reason for iron sucrose discordance, incidence of iron sucrose infusion reactions, and Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry (CDC/ATSDR) SVI rankings. Primary and secondary outcomes were analyzed using descriptive statistics and a multiple regression model.


Results: There were 613 treatment courses included in the pre-intervention group, while 543 treatment courses were included in the post-intervention group. Among both groups, patient demographics were not statistically different, and most treatment courses were administered at a Cone Health cancer center (82.5% in the pre-intervention group vs 79.6% in the post-intervention group). After the transition of 200 mg doses to IV push, the usage of 200 mg doses increased from 71.2% to 82.7% (p < 0.001), and the incidence of discordance was statistically unchanged (88.9% vs 87.7%; p < 0.26). The incidence of discordance due to insufficient dose decreased in the post-intervention group (68.4% vs 57.3%, p=0.001); however, the incidence of discordance due to prolonged duration increased in the post-intervention group (15.4% vs 19.5%, p=0.001). The incidence of infusion reactions was not statistically different between groups (0.3% vs 0.06%, p=0.15). There was not a clear difference in SVI rankings between concordant and discordant treatment courses. 


Conclusion: The transition of 200 mg iron sucrose doses to administration via IV push did not impact the incidence of discordance or infusion reactions, suggesting utility in the continued use of 200 mg push doses even after the resolution of the fluid shortage. The transition appeared to result in more patients receiving at least one gram of iron sucrose but increased the duration of the treatment course. There was no clear relationship found between SVI rankings and iron sucrose discordance.

Title: A Review of the Incidence of Pneumocystis Pneumonia Infection with or without Pneumocystis Pneumonia Prophylaxis in Patients with Brain Tumors 


Authors: Gabrielle McCammack, Marley Watson, Danielle Rustem, Brooke Rowling, Benjamin Albrecht, Kimberly Hoang, Manali Rupji, Xiyuan Ji, Jeffrey Switchenko


Background: Temozolomide is an oral alkylating agent administered with radiation for high-grade gliomas. According to the temozolomide drug monograph, patients should receive prophylaxis against Pneumocystis pneumonia (PCP) while receiving concurrent chemotherapy and radiation treatment. However, the Infectious Diseases Society of America recommends prophylactic antibiotics in chemotherapy regimens with less than 3.5% risk of contracting PCP. There are many suspected risks factors for development of PCP, yet recent studies have shown the incidence of PCP infection in this patient population is low, less than 1%. In addition, prophylactic antibiotics for PCP are associated with side effects and additional costs for patients. The decision to prescribe PCP prophylaxis for patients at Emory Healthcare is provider specific. The purpose of this study is to determine the incidence of PCP development with or without PCP prophylaxis and evaluate possible risk factors correlating with PCP development. 

Methods: This is a retrospective chart review of adult patients with brain tumors treated with concurrent phase temozolomide with radiation therapy at Emory Healthcare. Patients with high grade gliomas on concurrent temozolomide with radiation therapy will be included and will be categorized based on use of prophylactic antibiotics for PCP. Patients will be excluded for use of prophylactic antibiotics with activity against PCP for another indication, having reduced radiation courses, starting PCP prophylaxis after one week of chemotherapy treatment, or having insufficient documentation to confirm chemotherapy cycles. The primary outcome is to determine the incidence of PCP development with or without PCP prophylaxis, with safety as a secondary outcome. Descriptive statistics using mean and standard deviations for numerical variables and frequency and percentages for categorical clinicopathological variables. 

Results: A total of 67 patients were included in the study, 20 received PCP prophylaxis, 47 did not receive PCP prophylaxis. The mean age of patients was 54 years old in the prophylaxis group, and 55 in the without prophylaxis group. Most patients were on high dose steroids (prednisone equivalents > 20mg daily) for 1 month prior to treatment; 15 (75%) in the with prophylaxis group and 38 (80.9%) in the without prophylaxis group. Three patients in the without prophylaxis group had an immunocompromising condition at baseline; with 2 (4.3%) patients on hydroxychloroquine and 1 (2.1%) patient on infliximab. For patients on PCP prophylaxis, 9 (45%) were on trimethoprim/sulfamethoxazole, 10 (50%) inhaled pentamidine, and 1 (5%) on atovaquone. No patients developed a PCP infection; therefore, an analysis was not performed.

Conclusion: No cases of PCP were found for patients on treatment or 90 days post treatment in either the with or without prophylaxis groups. No events occurred despite 79.1% and 4.5% of the patient population being on high dose steroids or immunocompromising medications, respectively. Though some patients had a reduction in ALC while on treatment, more data is needed to determine if this is a true risk factor for development of PCP infection. Larger studies are needed to further assess and define risk factors for developing PCP infection while on concurrent temozolomide and radiation treatment and ultimately create a risk stratification tool that can better identify patients requiring PCP prophylaxis to minimize additional medication use and side effects.

Title: Assessment of Infusion Reaction Rates with Day 1 administration vs Day 5 Administration of Rituximab or biosimilars in Dose-adjusted R-EPOCH
Authors: Xiaoshan Chai, Elena Cukurs, Chynna Bambico, Sarah Gifford

Background
Infusion-related reactions (IRRs) are a significant concern with rituximab, especially when combined with cytotoxic chemotherapy, such as EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) for treating B-cell non-Hodgkin lymphomas. Rituximab, a monoclonal antibody targeting CD20 on B-cells, is known to elicit IRRs, including symptoms like fever, chills, and hypotension, particularly during the first infusion. Factors that increase the chance of developing IRRs include bulky disease with high tumor burden, increased cytokine release, and bone marrow involvement. The administration of rituximab for aggressive lymphomas with higher tumor burden further increases the risk of IRRs, necessitating vigilant supportive care to mitigate these reactions effectively. Management strategies involve premedication, titration of infusion rates, and monitoring. One approach to mitigate IRRs is by administering EPOCH first to debulk the tumor mass prior to introducing rituximab.  This study conducted a retrospective chart review to compare the incidences of infusion reactions in B-cell lymphomas patients who received rituximab on either day 1 (D1) or day 5 (D5) of   R-EPOCH from 2022 to 2024.

Methods
A retrospective chart review was conducted on patients over the age of 18 who had not previously received anti-CD20 monoclonal antibodies and had completed at least one cycle of R-EPOCH. Patient records were obtained from the electronic health records (EHR) systems of the oncology departments across sites at AdventHealth Central Florida Division. The primary outcome measured was the incidence of IRRs. Secondary outcomes included incidences of tumor lysis syndrome, types of IRRs, the maximum rate of rituximab infusion achieved, and the average time from the start of infusion to the onset of reactions.

Results
A total of eighty-three patients were included in the IRB-approved study, with 63 qualifying for primary analysis (11 in the D5 group and 52 in the D1 group). The primary endpoint revealed an incidence of IRR of 27.3% (3/11) in the D5 group and 30.8% (16/52) in the D1 group (P = 1). The most common type of infusion related reaction was hypotension in both groups. The median maximum infusion rate was 75 mL/hr in the D5 group and 100 mL/hr in the D1 group. The median time from infusion to the occurrence of IRRs was 110 minutes in the D5 group compared to 75 minutes in the D1 group.

Conclusion
We observed a similar rate of infusion-related reactions between groups. Further analysis will be necessary to confirm these findings and inform the optimal scheduling of rituximab administration within the R-EPOCH regimen.

Assessment Question
Based on the study's findings, which of the following statements best describes the impact of administering rituximab on Day 5 (D5) versus Day 1 (D1) in the R-EPOCH regimen regarding infusion-related reactions (IRRs)?
A. Patients in the D5 group experienced significantly fewer IRRs compared to the D1 group.
B. The incidence of IRRs was similar between the D1 and D5 groups
C. Rituximab infusion rates were lower in the D1 group compared to the D5 group, proving that early administration improves infusion tolerance
D. D1 rituximab administration resulted in less severe IRRs

Title: 
Evaluating Adherence to Eye Care Recommendations Amongst Patients Receiving Antibody Drug Conjugates for Gynecologic Malignancies


Authors: 
Ram Patel, PharmD
Kelli McCrum, PharmD
Michael Saxon, PharmD, BCPS


Objectives: 

1. Primary Objective: Assess compliance with prescribed eye drops.
2. Secondary Objectives:
   1. Identify correlations between adherence and ocular toxicity.
   2. Evaluate the effectiveness of patient education in mitigating adverse effects.

Self Assessment Questions: 
How does adherence to eye care measures correlate with the incidence of ocular toxicity? What factors influence patient adherence to prophylactic eye drop regimens?


Background: 
Antibody-drug conjugates (ADCs) such as mirvetuximab soravtansine and tisotumab vedotin have demonstrated efficacy in treating gynecologic malignancies but are associated with ocular toxicity, necessitating preventive eye care measures. This study aims to evaluate adherence to prophylactic eye drop regimens among patients receiving these therapies. The primary objective is to assess compliance with prescribed eye drops, while secondary objectives include identifying correlations between adherence and ocular toxicity and evaluating the effectiveness of patient education in mitigating adverse effects.


Methods: 
A cross-sectional, prospective study was conducted to assess adherence to prophylactic eye drops in patients receiving mirvetuximab soravtansine or tisotumab vedotin. Eligible patients completed a structured questionnaire evaluating adherence to steroid, lubricating, and vasoconstrictor eye drops (for tisotumab patients only). Inclusion criteria consisted of patients actively receiving ADC therapy, those prescribed prophylactic eye drops, and English-speaking patients. Data collection included duration of eye drop prophylaxis, frequency, dosage, and adherence, measured via a Likert scale. Patients also assessed their understanding of eye care importance and reported any ocular symptoms.


Results:
Preliminary data from four patient encounters indicate adherence to eye drop regimens at 100%, adequate understanding of their regimen at 100%, and minimal ocular toxicities. Reported toxicities include dry eyes being reported in 100% of patient encounters, blurry vision reported in 25%, and sensitivity to light reported in 25%. Our current hypothesis suggests that higher rates of adherence correlates with a lower incidence of ocular toxicity. With the limited number of patient encounters thus far demonstrating adherence and understanding of their regimens, more data is needed to draw any further conclusions or correlations. This study also examines patient-reported barriers to adherence, such as difficulty remembering doses, perceived ineffectiveness, or discomfort caused by the drops. 


Conclusion: 
This study provides valuable insights into adherence patterns, ocular toxicity risks, and the effectiveness of patient education in mitigating adverse events. Identifying key adherence barriers and their impact on toxicity rates may inform strategies to improve compliance and patient outcomes. Enhanced adherence to prophylactic eye care measures could reduce treatment-related complications, improving tolerability and quality of life for patients receiving ADC therapy. Ultimately, these findings may contribute to the development of standardized adherence protocols to optimize patient care and minimize ocular toxicity in clinical practice. 

Title: 
Incidence of nausea and vomiting with modified antiemetic regimens for patients receiving carboplatin AUC ≥ 4


Authors: Ramsey Shane, Amanda Cass


Objective: 
The purpose of this study is to determine the incidence of CINV with different antiemetic regimens and alterations in antiemetic regimens in patients receiving a modified antiemetic regimen with carboplatin AUC ≥ 4. 


Background: 
Chemotherapy-induced nausea and vomiting (CINV) is a major side effect of cancer treatment that affects patient quality of life. The National Comprehensive Cancer Network (NCCN) provides CINV recommendations for patients based on the emetic risk of the chemotherapy agents in their regimen, previous use of antiemetic agents, and patient risk factors. In the updated 2017 NCCN CINV guidelines, carboplatin emetic potential was updated from all carboplatin doses being moderately emetogenic to carboplatin AUC < 4 classified as moderately emetogenice and AUC ≥ 4 as highly emeticemetogenic. This recommendation adds neurokinin-1 receptor antagonists (NK-1 RA) to the standard regimen of a 5-HT3 receptor antagonists and dexamethasone with or without olanzapine for antiemetic prophylaxis in patients receiving carboplatin with AUC ≥ 4 mg/mL. There is debate amongst clinicians if the highly emetic classification is clinically necessary empirically citing additional adverse effects of antiemetic agents and financial burden for the healthcare system as reasons. The current practice at Vanderbilt University Medical Center (VUMC) includes a variety of antiemetic options for treatment plans including carboplatin AUC ≥4, and antiemetic regimens are decided by disease state groups based on their experience. Thus, not all regimens using carboplatin AUC ≥ 4 are treated as a highly emetic chemotherapy regimen.


Methods:
A retrospective, single-center cohort analysis was conducted including patients who received chemotherapy regimens containing carboplatin AUC ≥ 4 between January 2019 through July 2024 at the Vanderbilt Ingram Cancer Center (VICC). The treatment plans included in this study came from patients receiving treatment for either lung, gynecologic, or gastrointestinal cancers. Additionally, patients had to complete at least 2 cycles of therapy with carboplatin AUC ≥ 4. Patients were excluded if their treatment plan contained other cytotoxic chemotherapy agents except for paclitaxel. Data was collected through chart review in electronic medical record. The primary objective was to determine the incidence of CINV with different antiemetic regimens and if there was a change in the antiemetic regimen during treatment with carboplatin and up to three weeks after the carboplatin dose.  


Results: 
A total of 243 patients were screened for inclusion across the three disease states. There were 50 patients included from gynecology and lung cancers, and there were 41 patients included from the gastrointestinal cancers. Data analysis is still ongoing. 


Conclusion:
In Progress
 

Title: Reduced Corticosteroid Dosing in Pediatric Renal Transplant Patients
 
Authors: Alexander Durant, Aubrey Slaughter, Bailey Horne


Objective: To investigate the effects of maintenance corticosteroid dose reduction on blood pressure, hemoglobin A1c, and bone mineral density in pediatric renal transplant patients.
 
Background: Renal transplantation requires immediate and chronic immunosuppression to avoid acute organ rejection, which can compromise the integrity of the transplanted organ and be fatal. Consequently, a lifelong immunosuppressive regimen is required for all renal transplant recipients. One integral component of the backbone immunosuppressive regimen is corticosteroid therapy. In pediatric patients, there is a notable lack of data evaluating the deleterious effects associated with chronic corticosteroid therapy post-renal transplantation, as pediatric patients are often excluded from clinical trials and are consequently underrepresented in the literature. Wellstar MCG Health has recently transitioned from using prednisone or prednisolone doses of 0.1 mg/kg/day to 0.05 mg/kg/day, representing a 50% dose reduction in maintenance corticosteroid therapy. The purpose of this chart review is to investigate the effects of maintenance corticosteroid dose reduction on blood pressure, hemoglobin A1c, and bone mineral density in pediatric renal transplant patients.


Methods: This single-center, observational chart review included pediatric patients followed in the Wellstar MCG Health pediatric renal transplant clinic between 01/01/2022 and 12/31/2024. Exclusions included patients undergoing treatment for renal transplant rejection and patients no longer followed at the pediatric renal transplant clinic. The primary outcomes included a reduction in antihypertensive dosage or number of antihypertensive agents, an improvement in hemoglobin A1c or reduction in hyperglycemic agent dosage, and an improvement in BMD Z-score above -2.0 or a ≥20% improvement from baseline. Data analysis will utilize descriptive statistics for a non-parametric data set (e.g., median, IQR).


Results: A total of 13 patients were included in this chart review. The median patient age was 17 years. There were no notable differences between pre-reduction and post-reduction median systolic or diastolic blood pressure measurements or Z-scores. Dose reduction appeared to be associated with a decrease in median A1c of approximately 0.15 mg/dL. Corticosteroid dose reduction was also linked to a decrease in the number of prescribed osteoporosis medications in 57% of patients. The reduction had little impact on the number of prescribed anti-hypertensive and hyperglycemic agents prescribed per patient.


Conclusions: Corticosteroid dose reduction may contribute to improved glycemic control and a decrease in the number of osteoporosis medications prescribed per renal transplant patient. However, this review did not find a corresponding improvement in bone mineral density or blood pressure readings following the dose reduction.

Title: Assessing Utilization Trends of Granulocyte Colony-Stimulating Factors (G-CSF) in an Outpatient Cancer Setting   
Authors: Shayan Tavassoli, Alexia Greene, Thomas Morris 
Background: This study aims to identify gaps between current utilization and guideline recommendations by evaluating usage trends of granulocyte colony-stimulating factors at FirstHealth Outpatient Cancer Center. Previous literature showed that granulocyte colony-stimulating factors have shown both overuse and underuse when comparing to guideline recommendations.  
Methods: A retrospective observational study was conducted to evaluate the use of granulocyte colony-stimulating factors in cancer patients at FirstHealth Outpatient Cancer Center between March 1, 2022, and March 30, 2024. The study included patients with active diagnoses of breast, lung, pancreatic, or colorectal cancer who received a dose of granulocyte colony-stimulating factors. Exclusion criteria applied to patients receiving secondary prophylaxis for febrile neutropenia, weekly chemotherapy cycles, investigational agents, or those who underwent bone marrow or hematopoietic transplants within 30 days of chemotherapy. Patient characteristics included age, gender, cancer type, chemotherapy regimen, absolute neutrophil count, creatinine clearance, bilirubin levels, and provider documentation related to granulocyte colony-stimulating factors use. Patients were classified into three risk groups—high, intermediate, and low—based on the risk of febrile neutropenia according to NCCN guidelines. The primary outcome looked to find the percentage of patients who received at least one dose of granulocyte colony-stimulating factors for primary prophylaxis of febrile neutropenia during their chemotherapy regimen for the treatment of either lung, pancreatic, breast, or colorectal cancer. The secondary outcome looked to evaluate the characteristic differences between patients who received granulocyte colony-stimulating factors and those who did not during the study period. All patient data has been stored in a password-protected file with access restricted to investigators, ensuring confidentiality and data security throughout the study. 
Results: During the study’s timeframe, 4% (214/4931) patients with either lung, pancreatic, colorectal, or breast cancer received granulocyte colony-stimulating factors. Individual baseline characteristics were evaluated in total for 50 patients who received granulocyte colony-stimulating factors and 44 patients who did not receive granulocyte colony-stimulating factors. In the treatment group, 28% (14/50) vs. 6.8% (3/44) patients would be categorized as intermediate risk factor for febrile neutropenia based on guideline recommendations, and 86% (12/14) in treatment group vs. 100% (3/3) in control group of patients with intermediate risk chemotherapy regimen had risk factors to consider adding granulocyte colony-stimulating factors.
Conclusions: Overall, granulocyte colony-stimulating factor usage aligned closely with NCCN guideline recommendations in this study. Intermediate risk groups require consideration from providers when deciding if granulocyte colony-stimulating factors are necessary based on patient characteristics. Limited sample size may require further research to determine significant gaps of granulocyte colony-stimulating factors in comparison to guideline recommendations.