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