(130) Multicenter Study Comparing Stripping vs Ligation of Vas Deferens During Microscopic Denervation of Spermatic Cord in Men with Chronic Orchialgia Across the US
Abstract Introduction Microdenervation of the spermatic cord (MSCD) is an effective treatment modality for men with intractable scrotal content pain. For patients not interested in preserving fertility, some centers advocate ligation of the vas during denervation while others perfer stripping of the Vas deferens to preserve the vasal artery, hence preserving vasculature to testis and possibly decreasing post operative congestion pain. Objective This multicenter study analyzes outcomes of patients that underwent MSCD by either stripping or ligating the vas deferens. Methods A retrospective chart review of 85 patients who underwent MSCD from 2020–2023 was performed. Patients’ demographics including history of prior surgical procedures was recorded. Response to surgery was evaluated as either complete resolution of pain, partial resolution of pain or no improvement in pain. Results 85 patients underwent MSCD with a median (IQR) age of 36 (25.5–46.5) years and median duration of pain of 16 months. 37 patients underwent stripping of vas while 48 underwent ligation of vas during MSCD. Median follow up was 12 months. 21(43.5%) patients had prior inguinal scrotal surgery in ligation group compared to 5 (13.5%) in the stripping group p=0.003. The etiology of pain was similar between the groups. The response to MSCD between the 2 groups was similar (p=0.968), with similar post op complications (Table 1). Conclusions In men with intractable chronic scrotal content with no interest in preserving fertility, ligation or stripping of the vas deferens yields similar outcomes with regards to pain resolution. Both techniques are safe with no reports of any testicular atrophy. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Advisory board and speaker for Coloplast; consultant for Cynosure; advisory board and speaker for Halozyme; intellectual property with Masimo; advisory board for Promescent; consultant for Sprout; advisory board for Xialla.
Sexual Medicine Society of North America (SMSNA)/American Urological Association (AUA) telemedicine and men’s health white paper
Abstract Purpose The purpose of this white paper is to educate health care professionals about the evolution of telemedicine (TM) and to propose a hybrid model that leverages the strengths of traditional in-person medicine as well as virtual medicine while maximizing the safety and quality of men’s sexual health care. Literature Search Strategy A literature search focused on the use of TM in urology and men’s health was performed through PubMed/MEDLINE, Embase, and Web of Science (January 1, 2012–April 26, 2022). Keywords included all known permutations of the terminology used to refer to virtual health, care as well as the terminology used to refer to urologic diseases, issues specific to men’s health, and men’s sexual health concerns. Publications that emerged after the literature search that met this criterion also were incorporated. Opinion pieces, letters to the editor, meeting abstracts, and conference proceedings were excluded. Additional resources were retrieved, such as governmental technical reports, legislative updates and reviews, and blogs. This search strategy yielded 1684 records across databases after removal of duplicates. Abstracts from the retrieved records were reviewed for relevance. Relevant publications were defined as those that reported data on any aspect of TM use specific to urology, men’s health, and/or men’s sexual health. If relevance was unclear from the abstract, then the full text of the article was retrieved for a more detailed review. In addition, the published evidence-based practice guidelines relevant to care for erectile dysfunction, Peyronie’s disease, ejaculatory dysfunction, and hypogonadism were retrieved. The most common reasons for article exclusions were a focus on TM use in disciplines other than urology and the absence of data (ie, opinion pieces). After exclusions, a total of 91 publications remained and constituted the evidence base for this paper.
(079) Stripping vs Ligation of Vas Deferens in Microscopic Denervation of Spermatic Cord in Men with Chronic Orchialgia: A Multicenter Study
Abstract Introduction Microdenervation of the spermatic cord (MSCD) is an effective treatment modality for men with intractable scrotal content pain. For patients not interested in preserving fertility, some centers advocate ligation of the vas during denervation while others perfer stripping of the Vas deferens to preserve the vasal artery, hence preserving vasculature to testis and possibly decreasing post operative congestion pain. Objective This multicenter study analyzes outcomes of patients that underwent MSCD by either stripping or ligating the vas deferens Methods A retrospective chart review of 85 patients who underwent MSCD from 2020-2023 was performed. Patients’ demographics including history of prior surgical procedures was recorded. Response to surgery was evaluated as either complete resolution of pain, partial resolution of pain or no improvement in pain. Results 85 patients underwent MSCD with a median (IQR) age of 36 (25.5-46.5) years and median duration of pain of 16 months. 37 patients underwent stripping of vas while 48 underwent ligation of vas during MSCD. Median follow up was 12 months. 21(43.5%) patients had prior inguinal scrotal surgery in ligation group compared to 5 (13.5%) in the stripping group p=0.003. The etiology of pain was similar between the groups. The response to MSCD between the 2 groups was similar (p=0.968), with similar post op complications (Table 1). Conclusions In men with intractable chronic scrotal content with no interest in preserving fertility, ligation or stripping of the vas deferens yields similar outcomes with regards to pain resolution. Both techniques are safe with no reports of any testicular atrophy. Disclosure No.
Metastatic ER+ Breast Cancer: Mechanisms of Resistance and Future Therapeutic Approaches
Endocrine therapy is the main treatment for hormone receptor-positive (HR+) breast cancer. However, advanced tumors develop resistance to endocrine therapy, rendering it ineffective as the disease progresses. There are several molecular mechanisms of primary and secondary endocrine resistance. Resistance can develop due to either alteration of the estrogen receptor pathway (e.g., ESR1 mutations) or upstream growth factors signaling pathways (e.g., PI3K/Akt/mTOR pathway). Despite progress in the development of molecularly targeted anticancer therapies, the emergence of resistance remains a major limitation and an area of unmet need. In this article, we review the mechanisms of acquired endocrine resistance in HR+ advanced breast cancer and discuss current and future investigational therapeutic approaches.
Ocular toxicities associated with antibody drug conjugates and immunotherapy in oncology: clinical presentation, pathogenesis, and management strategies
Objective: This study is a comprehensive review of the clinical pharmacology, pharmacokinetics, efficacy, safety, and clinical applicability of amivantamab-vmjw for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutation. Data Synthesis: The literature search to identify clinical trials returned only the CHRYSALIS phase 1 study. In a phase I trial, amivantamab-vmjw was associated with an overall response rate (ORR) of 40% (95% CI, 29–51) in the EGFR exon20ins NSCLC patient population (n = 81) after platinum-based chemotherapy. There were 3 complete responses (CRs) and 29 partial responses (PRs). The median duration of response (DOR) was 11.1 months (95% CI, 6.9—not reached; NR). The median progression-free survival (PFS) was 8.3 months (95% CI, 6.5–10.9), and overall survival (OS) was 22.8 months (95% CI, 14.6—NR). Application to Clinical Practice: This review summarizes the pharmacology, clinical evidence, and use of amivantamab-vmjw for patients with locally advanced or metastatic NSCLC with EGFR exon20ins mutation. Conclusion: The FDA approval of amivantamab-vmjw, the first bispecific antibody to target the exon20ins mutation, represents an important advancement in the treatment of patients with NSCLC with limited effective treatment options. The initial findings of the CHRYSALIS trial demonstrate an overall tumor response benefit with an acceptable safety profile.
Abstract P4-07-56: Mayo Clinic Enterprise patterns of growth-factor utilization for sacituzumab govitecan (SG)-induced neutropenia among patients with metastatic triple negative breast cancer
Abstract Background: SG was approved in 2020 for the treatment of metastatic triple negative breast cancer (TNBC). The most common grade 3/4 adverse event in the ASCENT trial was neutropenia (51.2%) with a 6% incidence of febrile neutropenia. 1 Package insert recommendations do not endorse primary prophylactic growth factor support, rather only initiating if severe neutropenia occurs on treatment.2 Objective: This study retrospectively reviewed the utilization of growth factor support in patients (pts) with metastatic TNBC initiated on SG at each Mayo Clinic Enterprise site. Methods: We performed a multi-center, retrospective review of all pts with TNBC who received SG from January 2021 to December 2021 at Mayo Clinic sites in Minnesota, Florida, Arizona, and its community-based health system network. Data collected included history of neutropenia with previous cycles of SG resulting in a treatment delay, number of cycles, grade of neutropenia and cycle/day of treatment plan when growth factor added. Pts who received only one dose of SG were excluded. The Fisher’s exact test was utilized to compare the difference in the use of primary prophylaxis between sites. Results: 67 pts received at least two doses of SG. Within this cohort, 42 pts (63%) received growth factor support during treatment with SG. Growth factor support was most often added during the first two cycles (59.5%). A total of 12 patients initiated growth factor with no history of delays related to neutropenia and without neutropenia at the time of administration. Eleven of these pts had growth factor support added on Cycle 1 as primary prophylaxis. Primary prophylaxis was most common at Mayo Clinic – Rochester compared to the other sites (Table 1), however there was not a statistically significant difference (p=0.27). There were 26 pts (39%) with a treatment delay due to neutropenia while receiving SG, of which 21 (81%) were managed with the addition of growth factor (13 pegfilgrastim, 8 filgrastim). The median number of cycles for all pts was 5 (range: 1-25). Pts who received growth factor were treated with a median of 5 cycles (range: 1-25) and pts who did not receive growth factor were treated with a median of 4 cycles (range: 1-19) (p=0.10). Conclusions: We observed wide variability in the use of prophylactic growth factor between Mayo Clinic sites with SG. The optimal practice of growth factor use with SG warrants further exploration. References: 1. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541 2. Immunomedics, Inc. Trodelvy (sacituzumab govitecan-hziy) [package insert]. Foster City, CA: Gilead Sciences; 2020. Table 1: Grade of neutropenia for patients receiving SG when growth factor initiated Citation Format: Kaylee Clark, Jamie L. Carroll, Alvaro Moreno-Aspitia, Brenda Ernst, Farah Raheem, Ashley Heil, Beth Boyer, Kristin Mara, Matthew P. Goetz, Roberto A. Leon-Ferre, Karthik V. Giridhar, Jodi Taraba. Mayo Clinic Enterprise patterns of growth-factor utilization for sacituzumab govitecan (SG)-induced neutropenia among patients with metastatic triple negative breast cancer [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 P4-07-56.
PARP Inhibitors for Breast Cancer: Germline BRCA1/2 and Beyond
Poly-adenosine diphosphate ribose polymerase (PARP) inhibitors (PARPi) are approved for BRCA1/2 carriers with HER2-negative breast cancer in the adjuvant setting with a high risk of recurrence as well as the metastatic setting. However, the indications for PARPi are broader for patients with other cancer types (e.g., prostate and ovarian cancer), involving additional biomarkers (e.g., ATM, PALB2, and CHEK) and genomic instability scores. Herein, we summarize the data on PARPi and breast cancer and discuss their use beyond BRCA carriers.
Abstract 8962: Meta-Meta-Analysis of Outcomes of Valve-in-Valve TAVI Compared to Redo-SAVR
Introduction: Redo-Surgical valve replacement (Redo-SAVR) is the gold standard treatment for failed degenerated bioprosthetic valves. Recently approved less invasive Valve-In-Valve Transcatheter Aortic Valve Implantation (ViV-TAVI) procedure is becoming more popular but with limited evidence of its safety and efficacy compared to redo-SAVR. Hypothesis: We aimed to conduct the meta-meta analysis to evaluate the outcomes of ViV-TAVI compared to redo-SAVR. Methods: We conducted a systematic search of meta-analysis studies assessing outcomes of ViV-TAVR vs redo-SAVR using PubMed search engine and following PRISMA guidelines from inception to May 2021. A meta-meta-analysis was performed by obtaining a pooled odds ratio, 95% confidence interval (95%CI) using random-effects models to analyze outcomes of 30-day all-cause mortality and procedural mortality. Results: Nine meta-analysis studies were included. We found that there was a significantly lower odds of 30-day all-cause mortality (pooled OR:0.60; 95%CI:0.53-0.68; p<0.00001) with 0% heterogeneity (I2= 0%;p=0.53) in the ViV-TAVI compared to redo-SAVR. We also found a reduced risk of procedural mortality with ViV-TAVI compared to redo-SAVR (pooled OR:0.52; 95%CI:0.27-0.98; p=0.04) with 0% heterogeneity (I2= 0%;p=0.69) (Figure). Conclusions: ViV-TAVI is significantly associated with reduced risk of 30-day all-cause mortality, and procedural mortality compared to redo-SAVR. Our meta-meta-analysis supports that minimally invasive ViV-TAVI is a safe and better procedure for degenerated bioprosthetic valves in high-risk candidates.
New and emerging therapies for the treatment of relapsed/refractory diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common form of aggressive non-Hodgkin lymphoma. Approximately 40% of patients with DLBCL will experience disease relapse or will be refractory to first line chemoimmunotherapy, necessitating second-line salvage therapy. This has historically consisted of platinum-based chemotherapy regimens followed by autologous hematopoietic stem cell transplantation with curative intent for transplant-eligible patients or palliative chemotherapy for transplant-ineligible patients. In recent years there have been several new therapeutic agents approved for the treatment of relapsed/refractory DLBCL, thereby expanding the therapeutic landscape. These agents include polatuzumab vedotin, tafasitamab, loncastuximab tesirine, selinexor, and anti-CD19 chimeric antigen receptor T-cell therapies such as axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. This review summarizes the pharmacology, efficacy, safety, dosing, and administration of new agents recently approved for the treatment of relapsed/refractory DLBCL.