Single Institution Experience Research Articles

Re-treatment of locally recurrent uveal melanoma with repeat eye plaque I-125 brachytherapy: A single institution experience

PurposeEye plaque brachytherapy (EPBT) is the most common treatment for uveal melanoma with high local control rates of 95-100%. When local recurrences occur following EPBT, salvage options include enucleation, transpupillary thermotherapy (TTT), external beam radiation, or re-irradiation with EPBT. The purpose of this study is to report our institution's experience with EPBT re-irradiation for locally recurrent uveal melanoma. Material and MethodsPatients were included if they were previously treated for uveal melanoma with EPBT, experienced local recurrence, and were subsequently treated at our institution with EPBT from 2016- 2020. ResultsA total of 5 patients with median age 68 years were included. All patients were initially treated at an outside institution (OSI) with Iodine-125 or Ruthenium-106 EPBT. Mean time between EPBT at the OSI and EPBT at our facility was 130 months (range 28 – 231 months). Patients were re-irradiated with Iodine-125 EPBT prescribed to 85Gy over 168 hours. Median follow up after re-treatment at our center was 24 months. Local control among this cohort was 100%. Metastasis occurred in two patients after re-treatment, at 8 months and 7 months. At last follow up, all treated lesions were decreased in size. Four patients experienced worsening visual acuity. Four patients developed cataracts, while two patients developed radiation retinopathy with cystoid macular edema requiring anti-VEGF injections. One patient developed radiation retinopathy but did not require injections. No patients required enucleation. ConclusionRe-treatment of locally recurrent uveal melanomas with EPBT is a feasible alternative to enucleation with a high local control rate. Ocular toxicities have not been significant enough to require enucleation.

Long-term outcomes following proton therapy for non-metastatic central nervous system germinoma in children and adolescents

Background/PurposeRadiation is a key component in the treatment of central nervous system pure germinoma (PG) in children and adolescents. Proton therapy (PT) improves normal tissue sparing and potentially reduces adverse effects (AE). The aim of this study was to present the largest single institution experience utilizing PT for the management of PG. Materials MethodsWe enrolled 35 non-metastatic patients with PG that were treated with PT at our institution between July 2007 – September 2021. Most received induction chemotherapy (n = 31, 89 %) and whole ventricular irradiation with an involved field boost (n = 29, 83 %). The most common total dose was 30 CGE (n = 18, 51.4 %). We utilized the cumulative incidence method to estimate local control (LC), freedom from distant metastases (FFDM), freedom from progression (FFP), and overall survival (OS). Treatment related toxicity was assessed per CTCAE version 5. ResultsMedian follow-up was 6.2 years (range, 0.9–––15.2). The 10-year Kaplan-Meier estimates for LC, FFDM, FFP, and OS were 100 %, 100 %, 100 %, and 94 % respectively. The most common AE were hearing impairment requiring hearing aids (n = 3), transient hypersomnia requiring medication (n = 3), and new onset endocrinopathy (n = 1). Of the 23 evaluable patients ≥ 18 years old at last follow-up, 8 were high school graduates/in college, 8 college graduates, and 7 others gainfully employed. ConclusionsWhen utilized in modern multimodality treatment of non-metastatic PG, the precise dosimetry of PT does not compromise disease control. Although serious radiation side effects are rare, the 100% cure rate supports further investigation into selective radiation dose and volume de-escalation.

Adenoid Cystic Carcinoma of the Lacrimal Glands: A Single Institute Experience.

Adenoid Cystic Carcinoma of the Lacrimal Glands: A Single Institute Experience.

The impact of a bloodless medicine program on pancreatic resections: A single-institution experience incorporating patients with borderline-resectable and locally advanced pancreatic cancer

BackgroundPatients undergoing pancreatic resection who decline blood transfusion represent a clinical challenge. While bloodless medicine programs are valuable, their impact remains unclear, especially for those with borderline-resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC). MethodsRetrospective review of institutional databases identified patients who did not accept blood transfusion and underwent pancreatic resection from 2013–2022. We collated hemoglobin values, interventions to minimize symptomatic anemia, and patient outcomes. ResultsThirteen patients were identified. Median age was 63 years (range: 52–75 years) and eight (61.5 %) were female. All procedures were performed electively for invasive malignancy with PDAC as the most common diagnosis (11/13; 84.6 %) and pancreaticoduodenectomy as the most common procedure (11/13; 84.6 %). Vascular involvement was common in the 11 patients with PDAC (borderline-resectable: 7/11; 63.6 % and locally advanced: 3/11; 27.3 %), as was the use of multi-agent chemotherapy (n = 10) and preoperative radiotherapy (n = 8) prior to surgery. Median blood loss was 400 mL (range: 100–2200 mL). Intraoperative measures included acute normovolemic hemodilution in one patient and red blood cell salvage in three patients. Median preoperative hemoglobin was 12.3 g/dL (range: 10.3–14.2 g/dL) and median nadir hemoglobin was 9.2 g/dL (range: 5.2–11.8 g/dL). Median hospital stay was 10 days (range: 6–42 days). Thirty-day mortality was 0 % and one-year overall survival was 69.2 % with median follow-up of 26.4 months. ConclusionPancreatic resections can be performed safely in patients who decline blood transfusion, even with borderline-resectable and locally advanced PDAC. Avoiding transfusions and employing blood-conservation techniques does not appear to detrimentally impact survival.

Longitudinal Speech and Fistula Outcomes Following Primary Cleft Palate Repair at a Single Institution

Introduction Fistula formation and velopharyngeal insufficiency (VPI) are complications of cleft palate repair that often require surgical correction. The goal of the present study was to examine a single institution's experience with cleft palate repair with respect to fistula formation and need for surgery to correct velopharyngeal dysfunction. Methods Institutional review board approval was obtained. Patient demographics and operative details over a 10-year period were collected. Primary outcomes measured were development of fistula and need for surgery to correct VPI. Chi-square tests and independent t tests were utilized to determine significance (0.05). Results Following exclusion of patients without enough information for analysis, 242 patients were included in the study. Fistulas were reported in 21.5% of patients, and surgery to correct velopharyngeal dysfunction was needed in 10.7% of patients. Two-stage palate repair was associated with need for surgery to correct VPI (P = 0.014). Furlow palatoplasty was associated with decreased rate of fistula formation (P = 0.002) and decreased need for surgery to correct VPI (P = 0.014). Conclusion This study reiterates much of the literature regarding differing cleft palate repair techniques. A 2-stage palate repair is often touted as having less growth restriction, but the present study suggests this may yield an increased need for surgery to correct VPI. Prior studies of Furlow palatoplasty have demonstrated an association with higher rates of fistula formation. The present study demonstrated a decreased rate of fistula formation with the Furlow technique, which may be due to the use of the Children's Hospital of Philadelphia modification. This study suggests clinically superior outcomes of the Furlow palatoplasty over other techniques.

Outcomes of extracardiac Fontan operation: A single institution experience with 398 patients

ObjectiveThe study objective was to evaluate the outcomes of the extracardiac Fontan operation at a single institution. MethodsWe conducted a retrospective study of 398 patients from a single institution who underwent their initial extracardiac Fontan operation between 1997 and 2020. We determined the incidence of and risk factors for failure of the Fontan circulation, which includes death, Fontan takedown, heart transplantation, protein-losing enteropathy, plastic bronchitis, and functional status at the last follow-up. ResultsThe median follow-up time was 10.3 years (interquartile range, 6.4-14.6). The overall survival was 96% and 86% at 10 and 20 years after extracardiac Fontan operation, respectively. There were 6 early deaths (6/398, 1.5%) and 15 late deaths (15/398, 3.8%). Forty-nine patients (12.5%) developed failure of the Fontan circulation. Freedom from the failure of Fontan circulation was 88% at 10 years and 76% at 20 years. Risk factors for failure of the Fontan circulation were right ventricular dominance (hazard ratio, 4.7; P < .001; 95% CI, 2.1-10.5), aortic atresia (hazard ratio, 5.5; P < .001; 95% CI, 2.3-12.8), and elevated mean pulmonary artery pressure (hazard ratio, 2.3; P = .002; 95% CI, 1.2-6.7). ConclusionsRates of failure of the Fontan circulation are low after the contemporary extracardiac Fontan operation. Risk factors for failure of the extracardiac Fontan circulation include right ventricular dominance, aortic atresia, and elevated pulmonary artery pressures.

Real-world treatment patterns and clinical outcomes in patients with prostate cancer.: A single institution experience in Saudi Arabia.

To describe the current real-world treatment landscape, sequence of therapies, and outcomes in patients with prostate cancer (PC). A retrospective cohort study for PC patients diagnosed at King Abdullah Medical City Cancer Center in Makkah, Saudi Arabia, between January 2011 and December 2021. Data extracted from electronic medical records. A total of 282 patients with PC, with a mean age of 70 years and body mass index of 27. Among them, 274 (99%) had no family history of cancer, while 164 (58%) had hypertension and 125 (44%) had diabetes mellitus. Adenocarcinoma was the most common histology, found in 275 (97%) patients, with 99 (35%) having a Gleason score of 9. Notably, 184 (65%) patients presented with metastatic disease, and 147 (52%) with bone metastasis. While 198 (70%) patients underwent surgery, 184 (65%) did not receive radiotherapy. The most common first-line metastatic therapy was abiraterone in 23 (8%) patients, followed by enzalutamide in 7 (2.5%). During the study period, 167 (59%) patients survived, with an average treatment duration of 2.5 years. This study provides insights into real-world treatment patterns and clinical outcomes in patients with PC. The findings of this study highlight the importance of adhering to treatment standards and making informed clinical decisions.

End of life treatment in gynecological cancers in an integrated care model: A single institution experience from Oman.

e24036 Background: The use of chemotherapy closer to the end of life (EOL) and the optimal time of initiating palliative care interventions are subjects of ongoing debate. In a traditional care model (TCM), the institution of EOL care is a complex decision-making process, that involves patient, family members, and the oncologist, and involves transfer of patients from one to the other service. Integrated care model (ICM) is a newer concept, is designed around the needs of the patients, and may have the potential to improve quality of life and reduce the cost of healthcare towards EOL. At our center, we work in ICM in organ-based clinical programs and report the use of systemic treatment in patients with gynecological cancers (GC) nearing EOL. Methods: We analyzed retrospectively the use of chemotherapy and other systemic cancer-directed therapies in patients with GC, who died between Sept 2021 and December 2023 at a single institution. Information on the cancer-type, intention of treatment, and the time between last treatment and death was obtained from electronic patient records (EPR). Results: Over the study period, a total of 22 patients passed away. All patients received palliative care as part of the integrated care. All patients had been declared ‘not for resuscitation’ before death. Twelve patients had ovarian cancer, 5 had endometrial cancer, 4 had cancer of cervix, and one had vulvar cancer. The median age at diagnosis was 53 years (29-80). The systemic treatment was 1st line in 5 patients (23%), 2nd line in 8 patients (36%), and 3rd or more line in 6 patients (27%) respectively. Three patients (14%) did not receive any cancer-directed treatment (aged 80, 71 and 61). The ultimate line of treatment was cytotoxic chemotherapy for all patients, except for one who received Olaparib, and one who received trastuzumab with chemotherapy. There was no treatment-related mortality. The median time from last treatment to death was 55 days. Of the 19 patients who received treatment, 6 patients (32%) received treatment in the last 30 days, 5 between 30 and 60 days (26%), 5 between 60 and 90 days (26%), and 3 more than 90 days before death. Four patients died at home. Age at diagnosis (51 vs 55 years), age at death (51.5 vs 57.5 years), or time from diagnosis to death (11.5 vs 22 months), did not predict whether patients received treatment within the 30 days of death or earlier. Conclusions: All patients received palliative care as part of integrated cancer care. The ICM may have led to lower use of cancer treatment near EOL. The data may provide a benchmark for the region.

Real-world comparison of the efficacy of three CDK4/6 inhibitors (CDK4/6i) in the first-line treatment of endocrine-sensitive advanced breast cancer (aBC): Single institution experience.

e13080 Background: The combination of CDK4/6i and endocrine therapy (ET) is the standard of care in the first-line treatment of hormone receptor positive (HR+), HER2- aBC. In registrational studies, the progression-free survival (PFS) of all three CDK4/6i ranged from 23.8 to 28.12 months and overall survival (OS) from 53.9 to 66.8. In Croatia, both ribociclib and palbociclib were approved for clinical use in August 2018 and abemaciclib in November 2019. Methods: This retrospective study included patients with endocrine-sensitive HR+, HER2- aBC treated with aromatase inhibitor (AI) and CDK4/6i in the first-line setting between August 2018 and October 2023 at University Hospital Centre Zagreb. Ethics committee approval was obtained before the study was commenced. Patient demographics, clinical presentation, tumor characteristics and treatment data were collected. Real-world PFS (rwPFS) and OS analyses were done with the final data cut-off date of December 31, 2023, using type 1 right censoring. Data were analyzed using the Kaplan-Meier method. Results: Of the 274 patients treated with a combination of CDK4/6i and ET in the first-line setting, 172 with endocrine-sensitive tumors (98 de novo metastatic and 74 with treatment-free interval longer than 12 months) were eligible for the study, of which 41.86% (72/172) received ribociclib, 44.19% (76/172) palbociclib, and 13.95% (24/172) abemaciclib. Overall rwPFS was 48 months (95% CI:35-53). In the abemaciclib group, median rwPFS and OS were not reached in the follow-up period. The rwPFS was 48 (95% CI:27-53) for ribociclib and 47 (95% CI:30-49) for palbociclib. The overall OS was 62 months (95% CI:47-62). Median OS in the ribociclib group was 62 months (95% CI:40-62) and in the palbociclib group 52 (95% CI:42-54) months. Conclusions: The PFS and OS results for palbociclib and ribociclib in this retrospective real-world study correlate with results from randomized clinical trials, confirming some inferiority of palbociclib compared to ribociclib in the context of OS. Due to the later availability of the drug, larger sample size and longer follow-up will be needed to make definitive conclusions on the efficacy of abemaciclib.

The role of histology on the outcome of sinonasal carcinomas treated with radiotherapy: a single institution experience.

Sinonasal malignancies are a rare group of head and neck cancers. We aimed to report the oncological outcomes based on histological types in patients who underwent radiotherapy. In this single-institution study, we retrospectively retrieved and analyzed data of patients with sinonasal carcinomas who underwent radiotherapy during 2011-2016 as part of their treatment. The 3-year rate of local, regional, and distant recurrences, and overall survival were evaluated according to the histological type. A total of 28 patients were evaluated in this study, the majority of whom were male (60%). Squamous cell carcinoma (SCC), adenoid cystic carcinoma (ACC), and adenocarcinoma (ADC) were found in 15 patients (53.5%), 8 (28.5%), and 5 (18%), respectively. The highest rates of local and regional recurrences were observed in ACC and SCC, respectively. Distant recurrences were numerically more common in ADC. The 3-year OS was 48%, 50%, and 73% in SCC, ADC, and ACC, respectively. Different histopathologies of sinonasal cancer seem to have different patterns of failure, and this may be considered in the treatment approach.

Improving diversity in phase I oncology clinical trials: A single institution experience at the University of Colorado Cancer Center.

e13687 Background: Despite continued improvements in cancer outcomes, disparities persist between racial, ethnic, and socioeconomic groups. One potential driver is the lack of appropriate representation in clinical trials, including dose-finding studies. We implemented a set of initiatives including patient education, outreach, a Spanish-speaking bicultural clinic, and regular review of enrollment by race and ethnicity. To investigate the impact of these initiatives, we examined phase I clinical trial patient demographics and treatment outcomes before and after the intervention. Methods: We performed a retrospective review of patients enrolled in 2018-2019 (cohort 1[C1], pre- intervention) and 2022-2023 (cohort 2[C2], post-intervention). We collected patient demographics, area deprivation index (ADI), body mass index (BMI), ECOG performance status, and tumor type. Differences between cohorts were evaluated with T-tests, Chi-Square test, or the Fisher Exact test. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Hazard ratios (HR), confidence intervals (CI) and p values were derived using the cox proportional hazards method. A multivariable model for patients with colorectal cancers (CRC) was selected using the Akaike information criterion (AIC). Results: A total of 361 patients (C1 n = 209, C2 n = 152) were included. Overall, 52.4% of patients were female. The most common tumor sites were CRC (18.3%), pancreas (11.9%) and breast (10.8%). Study participants were 85.0% White, 3.3% Asian, 1.4% Black and 9.1% Hispanic, compared to cancer incidence in Colorado of 92.8%, 1.6% and 3.3% and 10.0%, respectively. Following our intervention, there was an increase in language preference other than English from 1.9% (4/209) to 6.6% (10/152) (p = 0.028) and in translated consents from 1.4% (3/209) to 5.9% (9/152) (p = 0.033). There was no statistically significant difference in race, ethnicity, insurance, or tumor type, although there was a non-statistically significant increase in Hispanic patients from 8.1% to 10.5%. Median PFS improved from 1.9 to 2.8 months (HR = 0.72, 95% CI 0.57-0.90, p = 0.003). ECOG 1 v. 0 was associated with inferior OS (HR = 1.35, 95% CI 1.06-1.73, p = 0.017), and BMI ≥18.5 v. &lt;18.5 was associated with superior OS (HR = 0.59, 95% CI 0.37-0.95, p = 0.03). AIC model of CRC (n = 66) revealed that ADI scores of 6-10 were associated with worse PFS and OS (p = 0.022 and p = 0.001, respectively). Conclusions: Our interventions resulted in an increase in accrual of non-English speaking patients, however, there was not yet a statistically significant change in overall race and ethnicity. Our study confirms poorer clinical outcomes for patients with higher ADI scores. Further research and intervention are warranted to mitigate disparities in clinical trial accrual and improve clinical outcomes for disadvantaged patients.

Association of baseline hypertension and hyperlipidemia with the clinical characteristics and outcomes in patients with colorectal cancer: A single institution experience.

e15522 Background: Hypertension (HTN) and hyperlipidemia (HLD) are widely prevalent diseases, but their effect on colorectal cancer (CRC) outcomes is limited. We aimed to study the effects of baseline HTN and HLD on CRC survival. Methods: We identified patients with stage 1-4 colorectal cancer diagnosed between 2011 and 2017 from tumor registry of a large safety-net hospital and NCI-designated Comprehensive Cancer Center. Patients with a diagnosis of HTN (ICD-9/10: I10, 401.9) and HLD (ICD 9/10: E78.0-E78.5, 272.0-272.4) at CRC diagnosis were compared with patients who did not have these comorbidities. Chi-square tests were used to compare categorical differences between groups. Multivariable logistic regression was used to identify factors associated with HTN and HLD. Overall survival (OS) was estimated using the Kaplan-Meier method and Cox proportional hazards model with an index date of tumor diagnosis until death. Patients who did not meet endpoint of interest were censored at the date of last clinical contact. Results: We identified 1,921 patients - 627 (33%) had HTN, 403 (21%) had HLD and 309 (16%) had HTN and HLD. The median age of diagnosis of CRC was 61 (IQR: 54-68) for HTN patients and 61 (IQR: 53-69) for HLD patients. Compared to patients without HTN or HLD, patients with HTN or HLD were more likely to be non-Hispanic Blacks (HTN: 39% vs 19%; HLD: 30% vs 24%), uninsured (HTN: 33% vs 17%; HLD: 36% vs 18%) and treated at safety-net hospital (HTN: 53% vs 24%; HLD: 55% vs 27%). These patients had a higher prevalence of other comorbidities including diabetes mellitus (HTN: 39% vs 7%; HLD: 50% vs 9%), anxiety (HTN:12% vs 3%; HLD: 14% vs 4%), and tobacco use (HTN: 16% vs 5%; HLD: 14% vs 7%). On multivariable analysis, HTN and HLD patients were older (HTN-OR: 1.05, 95CI: 1.04-1.06; HLD-OR: 1.03, 95CI: 1.02-1.05), had concurrent diabetes mellitus (HTN-OR: 4.2, 95CI: 2.9-6.3; HLD-OR: 4.5, 95CI: 3.2 - 6.4), depression (HTN-OR: 2.0, 95CI: 1.3-3.2; HLD-OR: 1.9, 95CI: 1.2-3.0), and cirrhosis (HTN-OR: 2.6, 95CI: 1.3-5.2; HLD-OR: 2.1, 95CI: 1.1-3.9) and treated at safety-net hospital (HTN-OR: 2.7, 95CI: 1.7-4.3; HLD-OR: 1.4, 95CI: 0.9-2.2). Compared to patients without HTN or HLD, OS was improved for HLD alone patients (HR: 0.58; 95CI: 0.38-0.89; P: 0.01), while it was not different for patients with HTN without HLD (HR: 0.99; 95CI: 0.81-1.2; P: 0.55) or HTN and HLD (HR: 0.92; 95CI: 0.75-1.13; P: 0.34). The 5-year yr OS for these groups were 65%, 77%, 66%, and 69% respectively. Conclusions: In this single institution cohort that includes a safety-net hospital, the prevalence of HTN or HLD at CRC diagnosis was higher among older and non-Hispanic Black CRC patients and associated with coexisting diabetes mellitus, anxiety, and tobacco use. CRC patients with HLD alone had a significantly better 5-yr OS compared to those without HTN or HLD, with HTN alone, and with HTN and HLD.

Clinical Presentations, Diagnosis, and Genetic Features of Hemophagocytic Lymphohistiocytosis: A Single Institutional Experience With the Saudi Population.

Background Hemophagocytic lymphohistiocytosis (HLH) is an uncommon, potentially fatal condition caused by high immune activation. The present study aimed to identify the clinical manifestations, geographic distribution, and associated pathogenic genetic mutations of HLH in Saudi Arabia. Method A retrospective cross-sectional study was conducted at King Fahad Medical City (KFMC), with a total of 59 patients diagnosed with HLH in the period between 2006 and 2018. All genetic results and clinical and biochemical data were retrieved and statistically analyzed using IBM SPSS Statistics for Windows, Version 25 (Released 2017; IBM Corp., Armonk, New York, United States). Results The results revealed that 48 patients (81.4%) had 15 pathogenic mutations of primary HLH whereas 8 (13.6%) patients had no genetic mutation. The most common variant mutation identified was c.1430C>T of the STXBP2 gene (42.4% of total patients), followed by c.1122G>A of the PRF1 gene (10.2% of patients), which demonstrated a distinctive geographic and tribal association. Patients with RAB27A mutation tend to present at an older age than the others with a median age of presentation of 5.5 months vs 2 months for patients with PRF1 mutations. No significant differences in clinical features were observed among the various groups. Conclusion This study highlights the incidence of genetic mutations among the Saudi population with HLH. The STXBP2 is the most common mutation followed by PRF1 mutations, many mutation variants are associated with a distinctive tribal and geographic association.

Mucosal melanoma treatment patterns and outcomes in real clinical practice: Single institution experience.

e21571 Background: Mucosal melanoma (MM) is a challenging malignancy to diagnose and treat, even with the advent of modern drug therapies. There is a lack of established surgical, radiological, or pharmacological treatment approaches for locally advanced or metastatic mucosal melanoma. This study analyzes the treatment practices and clinical outcomes at a single institution over a five-year period to understand real-world clinical practices. Methods: A сomprehensive, continuous, retrospective study analyzed medical records of adults with histologically confirmed MM at the N.N. Blokhin Russian Cancer Research Center from January 2018 to December 2023. Data was digitized into an electronic questionnaire, with patient follow-up conducted via telephone. Results: A total of 87 patients were identified, comprising 72 females (82.8%) from 31 regions of Russia. The median age was 67.8 years (ranging from 29.5 to 90.1 years). The patient breakdown was as follows: 6 with head&amp;neck MM (6.9%), 41 with vulvovaginal MM (47.1%), 5 with penile MM (5.7%), 27 with anorectal MM (31.0%), and 8 with gastrointestinal MM (9.2%). A significant portion of the patients presented with locally advanced (22.9%) or metastatic disease (67.8%), while 9.2% of the patients had undergone surgery and were being considered for adjuvant treatment. The most common sites of metastasis were regional lymph nodes (23%), liver (14%), and lungs (11.5%), with one patient having CNS metastasis. Mutational status was determined for 48 of the 87 patients, revealing driver mutations in 12 patients (Table). The majority of patients were initially treated with immunotherapy. The most frequently used therapies included monotherapy with anti-PD-1 agents (nivolumab or pembrolizumab, accounting for 41.6%) and a combination of ipilimumab and nivolumab (33.3%). After a median follow-up of 17.7 months, the median overall survival (OS) for the entire cohort was 18.1 months (with a 95% confidence interval ranging from 6.8 to 23.2 months), showing no significant statistical differences in outcomes based on the location of the mucosal melanoma or the type of treatment received. Conclusions: Mucosal melanoma remains an under-researched malignancy. There is a critical need for prospective, randomized trials to explore more effective treatment options for patients with this condition. [Table: see text]

Survival outcomes in patients with primary plasma cell leukemia treated with novel therapies at University of California San Diego Health: A single institution experience.

e19538 Background: Plasma Cell Leukemia (PCL) is a rare, but aggressive and devastating disease for which there is a paucity of data regarding the efficacy and safety of modern therapies to guide management. Data prior to the use of modern therapies showed abysmal overall survival (OS) of approximately 4-12 months. There is generally agreement that novel therapies have improved outcomes, but data supporting this is sparse due to the rarity of the disease. As such, there is currently no standard of care agreed upon by experts, and the specific approach for treatment currently varies by provider. Methods: In this single-center retrospective study, we review the outcomes of patients diagnosed with primary plasma cell leukemia (pPCL) from 2008 to 2023 who received at least one of the novel therapies of immunomodulatory drugs (IMiD), protease inhibitors (PI), and/or anti-CD38 antibodies at University of California San Diego Health. Baseline characteristics and efficacy outcomes were collected. Results: A total of 11 patients were identified who met the inclusion criteria. The median age at time of diagnosis was 50. The median circulating plasma cells at diagnosis was 34%. All but 2 patients had &gt; 20% circulating plasma cells. The remaining two had circulating plasma cells of 10% and 14% meeting the newly re-worked definition of plasma cell leukemia. One patient had a single extramedullary plasmacytoma at the time of diagnosis. High risk cytogenetics, defined as having t(4;14), t(14;16), t(14;20), Del17p, Gain1q, were characterized for all patients. 4 had one high risk mutation, 3 had two mutations. Only one patient’s first line did not include any of the novel therapies. 81% of patients’ first line of therapy included a form of cytotoxic chemotherapy (of which 55% of those were cisplatin, doxorubicin, cyclophosphamide, etoposide (PACE)). The most common first line of therapy was bortezomib (V), dexamethasone (D), PACE, +/- thalidomide (T) or lenalidomide (R), and +/- stem cell transplant (SCT). The other 19% of first line therapies contained exclusively novel therapies; namely VTD and daratumamab-RVD. Seven patients underwent SCT. One patient who underwent allogeneic transplant as part of their first line therapy has not yet relapsed 5 years post-transplant. Median OS was 28.8 months (95% CI 17.3 –not reached (NR)). First progression free survival (PFS) was 5.7 months (95% CI 2.3 – NR). For patients with available data, overall response rate (ORR) to 1st line of therapy was 60%. Conclusions: Our results demonstrate that the outcomes of patients with PCL have greatly improved with the use of novel therapies. The small sample size and heterogeneity of the treatments prohibited correlative statistical analysis. Prospective studies are needed to determine the best treatment option for this high-risk population which is excluded from most myeloma trials.

Molecular and clinical features of pancreatic acinar cell carcinoma: A single institutional experience.

e16335 Background: Acinar Cell Carcinoma (ACC) accounts for around 1% of pancreatic cancer. The molecular and clinical features of acinar cell carcinoma are less characterized. We sought to evaluate the clinical and molecular features of patients with ACC at MD Anderson Cancer Center. Methods: Patients with ACC who had germline and/or somatic molecular testing at MD Anderson Cancer Center from 2008 to 2022 were identified retrospectively. After obtaining approval of approval of the institutional review board genomic alterations including germline or somatic BRCA mutations, KRAS mutation, demographic, clinical, and pathological information were extracted from institutional databases using the Palantir Foundry software platform (Syntropy); this included natural language processing with subsequent validation by manual chart review. Overall Survival (OS) was calculated from the date of diagnosis to death or last follow-up. The Kaplan-Meier method was used for survival analysis. Results: 16 patients were identified with molecular testing results available. There were 13 males and 3 females. The median age of diagnosis was 62.5 years (range 49 -72). 14/16 patients (87.5%) had metastatic disease, one (6.25%) patient had borderline resectable disease and one (6.25%) had localized resectable disease at initial diagnosis. Median OS was for 24 months for patients with metastatic disease. There were 2 patients with mixed pathology, 1 with acinar cell carcinoma with neuroendocrine features and the 2nd had mixed acinar cell-ductal carcinoma. 15/16 (93.75%) patients were tested for KRAS and all 15 were KRAS wildtype. Somatic mutations in DNA damage repair genes (BRCA2, PALB2) were present in 3 patients (25%) and 2 patients had germline mutation (BRCA and ATM) (16%) out of 12 patients tested for those genes. 6/16 (37.5%) patients were treated with FOLFIRINOX at first line. 3/6 (50%) of these patients had partial response, 2/6 (33%) had stable disease and only 1/6 (16%) had progression. 5 patients were treated with FOLFOX based regimen and 1/5 (20%) had response, 2/5 (40%) had stable disease and 2/5 (40%) had progression of disease. 5 patients were treated with gemcitabine-based regimen and only 1 had response which received gemcitabine/nab-paclitaxel combined with cisplatin. Conclusions: ACC were KRAS wild type and had higher rates of germline/somatic mutations in DNA damage repair genes. Better treatment outcome of FOLFIRNIOX/ platinum-based regimens was suggested based on this limited patient dataset. Larger studies are needed to further understand the molecular features of ACC and guide the treatment of this rare entity of pancreatic cancer.

Successful robotic kidney transplantation for surgeons with no experience in minimally invasive surgery: a single institution experience: Erratum

Successful robotic kidney transplantation for surgeons with no experience in minimally invasive surgery: a single institution experience: Erratum

373P Burden of venous thromboembolism in patients with pancreatic cancer undergoing chemotherapy and impact of thromboprophylaxis: A single institution experience

373P Burden of venous thromboembolism in patients with pancreatic cancer undergoing chemotherapy and impact of thromboprophylaxis: A single institution experience

Short term outcomes of robotic assisted minimally invasive oesophagectomy: A single institutional experience.

e16112 Background: With the aim to decrease the rate of pulmonary complications associated with thoracotomy, minimally invasive esophagectomy (MIE) was introduced. Our purpose is to see the feasibility, safety and short-term outcomes of Robot-Assisted MIE (RAMIE). Methods: Seventy-three patients of carcinoma oesophagus who underwent Robotic Esophagectomy from May 2018 to March 2023 were included. Demographic profiles, neoadjuvant therapy, and operative and postoperative outcomes were evaluated. Results: Fifty-three patients were male while 29 were female, with median age of 60 years. Four patients had a previous history of surgery for cancer, 2 had carcinoma colon, one had carcinoma breast and another had carcinoma thyroid. 71% of patients had clinical stage 3 disease and the most common location of the tumour was the middle third (62.7%). 85.3% of patients received neoadjuvant therapy. Eighty percent of our patients underwent Robotic Mc Keown’s Esophagectomy while 20% had Robotic Ivor-Lewis Operation. The thoracic part in 1 patient was converted to open due to extensive adhesions in the right hemithorax. Mean abdominal console time was 146 min (+ 32 min) and thoracic console time was 120 min (+ 39 min); with a total operative time of 314 min (+ 44 min). Intraoperative blood loss was 300 ml (+ 86 ml). Post-operative and short-term outcomes: Out of 75 patients, 74.7% patients recovered well without any major complications. The most common complications were pulmonary (16%). Anastomotic leakage was found in 8 patients of whom 4 patients were managed conservatively, 1 required oesophageal stenting, other 2 had bedside opening of neck wound and 1 required pectoralis major muscle flap cover. Clinically recurrent laryngeal nerve palsy was found in 2 patients while Chylothorax was found in 2 patients. The median ICU stay was 3 days (range 1-28 days), whereas the median hospital stay was 8 days (range 6-38 days). Our 30-day mortality was 1.3% and this patient died on POD8 due to sepsis and respiratory failure, while 90 day mortality was 4%. Oncological Outcomes: Pathological complete response was seen in 21.3% of patients and median lymph nodal yield was 21 nodes (range 9-68). There was one microscopic margin positivity. Conclusions: RAMIE is a technically feasible and safe procedure with good lymph node yield and R0 resections. Postoperative complications and short-term oncologic results are comparable to other high-volume centres.

Fresh frozen plasma (FFP) for hypogammaglobulinemia (HypoG) in patients (Pts) with recurrent infections (Infxs) after B-cell directed treatment: A single institution experience with economic impact analysis.

e13519 Background: The incidence of hypoG with recurrent infxs has rapidly increased in pts undergoing B-cell targeted therapies, including monoclonal and bispecific antibodies and chimeric antigen receptor (CAR) T-cell therapies, for benign and malignant diseases. These novel therapies produce life-threatening hypoG due to persistently severe depletion of B cells. The standard of care (SoC) for hypoG is intravenous immunoglobulin (IVIG) infusion, which is costly with limited efficacy. FFP is known to have B cell-related immunologic elements (IgM, A, &amp; D) and complement that are essential for fighting infx. Methods: We retrospectively identified pts between January 2020 and 2024 diagnosed with hypoG who received FFP or IVIG for recurrent infx from B-cell targeted therapies (67% received anti-CD20 agents). Data was collected 12 months (mos) before and after FFP or IVIG infusion. HypoG-related recurrent infx are usually chronic with no documented positive cultures. Therefore, we reviewed each pt’s subjective reports of infectious improvement. Our primary endpoint was the annualized infx rate before and after FFP or IVIG, with a secondary outcome comparing hospitalization rates. Infxs were measured by courses of antimicrobial therapy. A Kaplan-Meier analysis was performed with accompanying log-rank testing for the primary outcome. Results: 21 pts met inclusion criteria, 5 received FFP and 16 received IVIG. Median (mdn) age was 72 years (range, 46 - 87) and 57.1% were female. 66.6% received FFP/IVIG after therapy for hematologic cancers (62% B cell lymphoma), 28.6% for solid tumors, and 4.8% for autoimmune disorders. The mdn number of infxs in the 12 mos preceding FFP and IVIG were 3 (2 - 5) and 3 (0 - 13), respectively, while the mdn number of infx-related hospitalizations prior to intervention was 2 (1 - 3) and 0 (0 - 6). The mdn number of infxs in the 12-mo period following FFP initiation was 1 (0 - 2) versus 0 (0 - 3) after IVIG initiation, and mdn number of infx-related hospitalizations post-intervention was 0 (0 - 1) and 2 (0 - 7). The mdn time to first infx on FFP and IVIG were 5 mos (2 - 12) and 4 mos (1 - 12), respectively, with one pt in each cohort not having an outcome. All 5 pts in the FFP cohort had documented subjective improvement of infectious symptoms after first infusion, as opposed to none in the IVIG cohort (p = 0.000). There was no significant difference in mdn time to first infx (p = 0.591). Conclusions: IVIG costs about 10,000 USD per infusion compared to 120 USD for FFP, excluding labor, distribution and facility charges. The estimated total IVIG market share in the US is about 5 billion in 2024. Replacement of IVIG with FFP will alleviate supply constraints and save US healthcare at least 4.95 billion USD yearly. Comparable rates of infx with FFP versus IVIG suggest that FFP is non inferior to the SoC for treating hypoG.