Management of Advanced Penile Cancer Chahoud, Jad; Kohli, Manish; Spiess, Philippe E
Mayo Clinic proceedings,
03/2021, Letnik:
96, Številka:
3
Journal Article
Recenzirano
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Penile squamous cell carcinoma (PSCC) is a rare cancer, with approximately 2000 new cases in the United States and 35,000 globally every year. Multiple risk factors are involved in PSCC, but most ...importantly, the high-risk human papillomavirus infection is thought to be present in approximately 50% of cases. Penile squamous cell carcinoma presents as localized or locally advanced disease. Multiple prognostic markers have been explored over the past 3 decades, but lymph node status remains the strongest predictor of clinical outcomes. Surgical decisions are based on the primary tumor pathologic findings, nodal clinical examination, and imaging results. Most patients with high-risk advanced PSCC benefit from a multimodal treatment approach combining chemotherapy with consolidation surgical treatment. The role of neoadjuvant chemotherapy with radiation therapy has not been well explored in PSCC. Prospective clinical studies, like the International Penile Advanced Cancer Trial, have been launched to provide high-level evidence for multimodal treatment. The International Penile Advanced Cancer Trial is the first randomized clinical trial among patients with PSCC and is currently accruing, with the expectation to generate results in 2023. Unfortunately, most patients with high-risk locally advanced PSCC will have relapsed or refractory cancer after cisplatin-based combination chemotherapy. These patients have dismal outcomes with salvage chemotherapy, highlighting the major unmet need to expand our knowledge of the disease's biology and develop clinical trials that use novel systemic agents. This narrative review synthesizes relevant publications retrieved from PubMed. Our aim is to discuss current approaches in the management of PSCC, summarize ongoing efforts to improve care, and identify future areas for enhancing our understanding of the disease.
Augmented reality is widely used in aeronautics and is a developing concept within surgery. In this pilot study, we developed an application for use on Google Glass optical head-mounted display to ...train urology residents in how to place an inflatable penile prosthesis. We use the phrase Augmented Reality Assisted Surgery to describe this novel application of augmented reality in the setting of surgery. The application demonstrates the steps of the surgical procedure of inflatable penile prosthesis placement. It also contains software that allows for detection of interest points using a camera feed from the optical head-mounted display to enable faculty to interact with residents during placement of the penile prosthesis. Urology trainees and faculty who volunteered to take part in the study were given time to experience the technology in the operative or perioperative setting and asked to complete a feedback survey. From 30 total participants using a lO-point scale, educational usefulness was rated 8.6, ease of navigation was rated 7.6, likelihood to use was rated 7.4, and distraction in operating room was rated 4.9. When stratified between trainees and faculty, trainees found the technology more educationally useful, and less distracting. Overall, 81% of the participants want this technology in their residency program, and 93% see this technology in the operating room in the future. Further development of this technology is warranted before full release, and further studies are necessary to better characterize the effectiveness of Augmented Reality Assisted Surgery in urologic surgical training.
Background Clinical studies investigating topical hemostatic agents have not used standardized definitions for intraoperative bleeding. The Food and Drug Administration has recently sought use of a ...validated, clinician-reported scale to standardized bleeding sites in these clinical studies. The intent of a scale is to reduce patient risk, generate labeling claims, and allow comparisons among study results. We describe the development and validation of an intraoperative bleeding severity scale. Methods A concept phase defined the framework of the scale. A feasibility and validation phase investigated the usability, clarity, relevance, and reliability (ie, intra- and interobserver concordance) among surgeons and surgical specialties as required by the Food and Drug Administration for the validation of a clinician-reported scale. Data were collected using an online tool. A total of 144 surgeons participated in the 3 phases. Results The scale developed during the concept phase achieved an average intraobserver concordance of 0.97 and an interobserver concordance of 0.89 in the feasibility phase ( N = 33); a concordance of 1.0 is perfect. The scale was refined and then achieved an average intraobserver concordance of 0.98 and an interobserver concordance of 0.91 in the validation phase with unanimous agreement by surgeons from multiple surgical specialties that the scale can be implemented into clinical studies ( N = 102). Conclusion This study validated an intraoperative bleeding severity scale for use in clinical studies investigating hemostatic agents. The scale was usable, clear, and clinically relevant with excellent reliability. The scale fulfills requirements of the Food and Drug Administration for a clinician-reported scale and can be used to generate clinically meaningful labeling claims.
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