Citations

Abstract Introduction Inflatable penile prosthesis reservoir herniation or migration may occur with space of Retzius or submuscular placement. The dangers of high submuscular placement include bowel or bladder perforation (from blind instrument passage) and or bowel herniation (from unintentional peritoneal placement and stretching of small opening with reservoir filling). Even under direct vision submuscular placement, reservoirs can ultimately reside into the scrotum, retroperitoneum, and lateral abdominal wall. The Tubing, Hitch And Lasso, Intussusception Anchor (THALIA) technique was recently developed to prevent reservoir migration with placement either submuscularly or in the space of Retzius, but video of this technique has not been previously published. Objective To visually demonstrate the proper surgical technique of THALIA during IPP reservoir placement. Methods An IPP surgical candidate at high risk of complications should reservoir migration occur was identified. Video of THALIA technique performed during IPP surgery was recorded using an in-light overhead camera and a GoPro aseptically positioned on the lead surgeon. Results Successful demonstration of THALIA technique during IPP placement. Conclusions THALIA technique is a feasible option to aid prevention of penile implant reservoir herniation. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

Abstract Introduction Sexual Health Curriculum (SHC) in medical schools has been insufficiently training medical students for many years. While most medical schools report teaching a SHC, many medical students and residents report being inadequately trained in sexual health. This has led to infrequent physician screening for sexual problems due to insufficient knowledge and a lack of training about sexual function and dysfunction. Objective To investigate the current body of literature for changes in SHC in medicals schools in the last 20 years, and to identify any discrepancies between SHC taught in medical school and resident and medical student comfort in treating Sexual Health Dysfunction. Methods A literature review was conducted in PubMed on “sexual health education in medical school”, and of 16,962 results 37 relevant papers published in the U.S. and Europe were identified and analyzed. Results In 2003 86% of medical schools reported teaching over 3 hours of SHC, but by 2021 only 65% of students and 50% of PGY 4/5 Urology residents recalled a dedicated SHC in medical school. Consistently 50% of medical students are unsatisfied with their SHC, 52% are rarely or never evaluated on their sexual history taking skills, and 7% report not learning about human sexuality at all. Most German medical students believe that sexual health courses should be mandatory. Medical students have overall positive attitudes towards sexual and gender minority populations but lack adequate knowledge, especially about transgender and intersex health. Only 55% of 3rd/4th year OBGYN residents reported feeling comfortable in performing a targeted sexual dysfunction exam, and 66% of residents in Family Med, IM, OBGYN, and Psych had no previous educational experience in sexual problem management. Conclusions Sexual health curriculum in medical schools has not significantly improved in the last 20 years, leading to students and residents inadequately prepared to treat sexual health dysfunctions. The adoption of previously proposed SHC competencies for medical schools should be strongly considered. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

PURPOSE Polycythemia vera (PV) is characterized by JAK/STAT activation, thrombotic/hemorrhagic events, systemic symptoms, and disease transformation. In high-risk PV, ruxolitinib controls blood counts and improves symptoms. PATIENTS AND METHODS MAJIC-PV is a randomized phase II trial of ruxolitinib versus best available therapy (BAT) in patients resistant/intolerant to hydroxycarbamide (HC-INT/RES). Primary outcome was complete response (CR) within 1 year. Secondary outcomes included duration of response, event-free survival (EFS), symptom, and molecular response. RESULTS One hundred eighty patients were randomly assigned. CR was achieved in 40 (43%) patients on ruxolitinib versus 23 (26%) on BAT (odds ratio, 2.12; 90% CI, 1.25 to 3.60; P = .02). Duration of CR was superior for ruxolitinib (hazard ratio [HR], 0.38; 95% CI, 0.24 to 0.61; P < .001). Symptom responses were better with ruxolitinib and durable. EFS (major thrombosis, hemorrhage, transformation, and death) was superior for patients attaining CR within 1 year (HR, 0.41; 95% CI, 0.21 to 0.78; P = .01); and those on ruxolitinib (HR, 0.58; 95% CI, 0.35 to 0.94; P = .03). Serial analysis of JAK2V617F variant allele fraction revealed molecular response was more frequent with ruxolitinib and was associated with improved outcomes (progression-free survival [PFS] P = .001, EFS P = .001, overall survival P = .01) and clearance of JAK2V617F stem/progenitor cells. ASXL1 mutations predicted for adverse EFS (HR, 3.02; 95% CI, 1.47 to 6.17; P = .003). The safety profile of ruxolitinib was as previously reported. CONCLUSION The MAJIC-PV study demonstrates ruxolitinib treatment benefits HC-INT/RES PV patients with superior CR, and EFS as well as molecular response; importantly also demonstrating for the first time, to our knowledge, that molecular response is linked to EFS, PFS, and OS.

Abstract BackgroundNigeria has the highest cancer burden in Africa with 124,815 cancer cases and 78,899 cancer deaths in 2020. The limited number of oncology specialists, inaccessibility of essential cancer medicines like chemotherapies, and suboptimal delivery of cancer care lead to poor treatment outcomes. Oncology pharmacy (OP) practitioners are critical oncology professionals in the multidisciplinary team (MDT) for cancer treatment globally. In Nigeria, there is a limited number of OP practitioners providing services like reconstitution of chemotherapy, clinical research, safe use of biosafety cabinets, and monitoring of adverse drug reactions. Although the interest in oncology pharmacy is increasing, the educational needs, available skill sets, and directed training in oncology pharmacy across the nation are unknown. In this study, we examined the educational needs of OP practitioners and worked with the West African College of Pharmacy West African Postgraduate College of Pharmacists (WAPCP), Oncology Pharmacy Practitioners Association of Nigeria (OPPAN), and the International Society of Oncology Pharmacy Practitioners to upgrade the oncology pharmacy practice in Nigeria. MethodA cross-sectional study with a semi-structured questionnaire was done in 2021 with 39 pharmacists working in oncology centers across Nigeria. General descriptive statistics and qualitative analysis was performed. ResultsThere is no board-certified oncology pharmacist in Nigeria. More than 50% of the general pharmacists working in oncology centers are responsible for chemotherapy reconstitution. Understanding chemotherapy reconstitution (automation of chemotherapeutic mixing, use of radiopharmaceuticals, etc), use of biosafety cabinets, knowledge of pharmacology, designing treatment protocols, data management, immunotherapy delivery, and oncology clinical trials were some of the most significant educational needs of the OP practitioners in Nigeria. OP practitioners are lacking in most cancer centers and MDTs. ConclusionThere is an urgent need for a specialty postgraduate training programme in oncology pharmacy in Nigeria. This would help increase oncology clinical trials, improve delivery of cancer medicines, quality of care, and management of toxicities. The West African Postgraduate College of Pharmacists and OPPAN need appropriate training resources to develop an oncology pharmacy curriculum, promote the specialty and collaborate with global institutions for board certifications. Citation Format: Runcie C. Chidebe, Ramatu M. Alabelewe, Darlingtina K. Esiaka, Gloria C. Okwu, Tochukwu C. Orjiakor, Nwamaka Lasebikan, Jacinta Emejulu, Adamu A. Umar, Ndifreke Okwuegbunam, Funsho David, Toyosi Adepoju, Krishna Prasad Sapkota, Candidus C. Nwakasi, Agha A. Agha, Simeon C. Aruah, Katy Graef, Richard Mshelia, Rob Duncombe, Matthew O. Nwaneri, Noel Wannang, Cindy O’Bryant, R. Donald Harvey, Peace C. Babalola, Folakemi T. Odedina. Who reconstitutes my chemotherapy? Examining the educational needs of oncology pharmacy practitioners in Nigeria [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 723.

Introduction: Eculizumab is a monoclonal antibody that binds to complement protein C5, inhibiting complement-mediated thrombotic microangiopathy. It is approved for several indications including atypical hemolytic uremic syndrome. Additionally, eculizumab is used off-label for antibody-mediated rejection and C3 glomerulopathy in renal transplant recipients. Due to limited data available, the purpose of this study was to describe the use of eculizumab treatment in renal transplant recipients. Design: This retrospective single-center study evaluated the safety and efficacy of eculizumab for on- and off-label indications in renal transplant recipients. Adult renal transplant recipients receiving at least 1 dose of eculizumab posttransplant between October 2018 and September 2021 were included. The primary outcome evaluated was graft failure in patients treated with eculizumab. Results: Forty-seven patients were included in analysis. The median age at eculizumab initiation was 51 years [IQR 38-60], with 55% being female. Indications for eculizumab included atypical hemolytic uremic syndrome/thrombotic microangiopathy (63.8%), antibody-mediated rejection (27.7%), C3 glomerulopathy (4.3%), and other (4.3%). Graft failure occurred in 10 patients (21.3%) with a median of 2.4 weeks [IQR 0.5-23.3] from transplant to graft failure. At last follow-up (median 56.1 weeks), 44 (93.6%) patients were alive. After eculizumab initiation, renal function improved at 1 week, 1 month, and last follow-up. Conclusion: Eculizumab treatment demonstrated a benefit on graft and patient survival compared to reported incidence in thrombotic microangiopathy and antibody-mediated rejection. Due to the small sample size and retrospective design, further research is warranted to confirm these results.

Abstract Background The shared inherited genetic contribution to risk of different cancers is not fully known. In this study, we leverage results from 12 cancer genome-wide association studies (GWAS) to quantify pairwise genome-wide genetic correlations across cancers and identify novel cancer susceptibility loci. Methods We collected GWAS summary statistics for 12 solid cancers based on 376 759 participants with cancer and 532 864 participants without cancer of European ancestry. The included cancer types were breast, colorectal, endometrial, esophageal, glioma, head and neck, lung, melanoma, ovarian, pancreatic, prostate, and renal cancers. We conducted cross-cancer GWAS and transcriptome-wide association studies to discover novel cancer susceptibility loci. Finally, we assessed the extent of variant-specific pleiotropy among cancers at known and newly identified cancer susceptibility loci. Results We observed widespread but modest genome-wide genetic correlations across cancers. In cross-cancer GWAS and transcriptome-wide association studies, we identified 15 novel cancer susceptibility loci. Additionally, we identified multiple variants at 77 distinct loci with strong evidence of being associated with at least 2 cancer types by testing for pleiotropy at known cancer susceptibility loci. Conclusions Overall, these results suggest that some genetic risk variants are shared among cancers, though much of cancer heritability is cancer-specific and thus tissue-specific. The increase in statistical power associated with larger sample sizes in cross-disease analysis allows for the identification of novel susceptibility regions. Future studies incorporating data on multiple cancer types are likely to identify additional regions associated with the risk of multiple cancer types.

Abstract Background: Historically, less than 10% of adult patients with cancer enroll in clinical trials, however, enrollment dropped further at the onset of the COVID-19 pandemic. Barriers to trial participation during the pandemic have not been reported. As part of the TBCRC 057 survey on the impact of the pandemic on willingness to participate in breast cancer trials, we assessed reasons for reluctance to participate in trials during the pandemic. Methods: US residents who self-reported a breast cancer diagnosis were eligible to complete the online survey 8/6/21-9/30/21. Respondents indicated whether they were current trial participants and, if not, their willingness to consider participating in a trial during the pandemic using a 5-point scale (0-not at all willing to 4-definitely willing). Respondents who were not current trial participants and who were not “definitely willing” to consider participation during the pandemic were characterized as “reluctant” and asked to select reasons for their reluctance from a checklist. Pandemic-related anxiety was assessed on an 11-point scale (0-no anxiety to 10-worst anxiety possible). Respondents indicated how the option to conduct trial activities online would affect their decision to participate in a trial (much less likely, somewhat less likely, would not affect my decision, somewhat more likely, or much more likely). In exploratory analyses, we evaluated whether pandemic-related anxiety and favorable reactions towards opportunities to conduct trial activities online were associated with reluctance to consider trial participation during the pandemic due to fear of SARS-CoV-2 exposure. Means were compared with two sample t-tests and proportions with Fisher’s exact tests. Results: Of 385 survey respondents, 185 (48%) were characterized as reluctant to consider trial participation during the pandemic. Among these 185, median age was 55 (range 25-80), 85.7% were non-Hispanic White, 48.1% had metastatic disease and 44.2% received care at academic centers. Reasons for reluctance to consider trial participation during the pandemic cited by ≥15% of the 185 reluctant respondents are shown in the Table. Respondents who selected fear of exposure to SARS-CoV-2 as a reason for their reluctance to consider participating in a trial during the pandemic had higher mean pandemic-related anxiety (7.0 vs 5.2, p&lt; 0.001). These respondents were more likely to indicate telemedicine doctor visits (p=0.01), virtual consents (p=0.001) and online study questionnaires (p=0.001) would make them somewhat or much more likely to participate in trials than respondents who did not select fear of exposure to SARS-CoV-2 as a reason for their reluctance. Conclusions: Reasons for reluctance of patients with breast cancer to consider participation in clinical trials during the pandemic are multifactorial. Although concerns about safety and efficacy remain prominent, fear of exposure to SARS-CoV-2 drives unwillingness to participate in &gt;25% of reluctant patients. Trial accrual may benefit from incorporation of electronic activities when possible. Table Citation Format: Karen L. Smith, Carolyn Mead-Harvey, Gina L. Mazza, Albert E. Holler, Eileen Shinn, Elizabeth Frank, Michelle Melisko, Cyd Eaton, Jeannine M. Salamone, Teri Pollastro, Patricia Spears, Antonio C. Wolff, Gabrielle B. Rocque. Reasons for Reduced Willingness to Participate in Clinical Trials During the COVID-19 Pandemic: The Translational Breast Cancer Research Consortium (TBCRC) 057 Survey [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-08-07.

AbstractBackgroundThe Cavernous Hemangioma Exclusively Endonasal Resection (CHEER) staging system has become the gold standard for outcomes reporting in endoscopic orbital surgery for orbital cavernous hemangiomas (OCHs). A recent systematic review demonstrated similar outcomes between OCHs and other primary benign orbital tumors (PBOTs). Therefore, we hypothesized that a simplified and more comprehensive classification system could be developed to predict surgical outcomes of other PBOTs.MethodsPatient and tumor characteristics as well as surgical outcomes from 11 international centers were recorded. All tumors were retrospectively assigned an Orbital Resection by Intranasal Technique (ORBIT) class and stratified based on surgical approach as either exclusively endoscopic or combined (endoscopic and open). Outcomes based on approach were compared using chi‐squared or Fisher's exact tests. The Cochrane‐Armitage test for trend was used to analyze outcomes by class.ResultsFindings from 110 PBOTs from 110 patients (age 49.0 ± 15.0 years, 51.9% female) were included in the analysis. Higher ORBIT class was associated with a lower likelihood of gross total resection (GTR). GTR was more likely to be achieved when an exclusively endoscopic approach was utilized (p < 0.05). Tumors resected using a combined approach tended to be larger, to present with diplopia, and to have an immediate postoperative cranial nerve palsy (p < 0.05).ConclusionEndoscopic treatment of PBOTs is an effective approach, with favorable short‐term and long‐term postoperative outcomes as well as low rate of adverse events. The ORBIT classification system is an anatomic‐based framework that effectively facilitates high‐quality outcomes reporting for all PBOTs.