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Purpose: To evaluate evidence on germline and somatic genomic testing for patients with metastatic prostate cancer and provide recommendations., Methods: A systematic review by a multidisciplinary panel with patient representation was conducted. The PubMed database was searched from January 2018 to May 2024. Articles were selected for inclusion if they reported on patients with metastatic prostate cancer who received a germline or somatic genomic test and/or made comparisons between those tests, reported detection rates, prognostic information, or treatment implications., Results: A total of 1,713 papers were identified in the literature search. After applying the eligibility criteria, 14 remained: eight systematic reviews and six clinical trials., Recommendations: Patients with metastatic prostate cancer should undergo both germline and somatic DNA sequencing using panel-based assays. These tests can guide the use of poly(ADP-ribose) polymerase inhibitors, which have a survival benefit in metastatic castration-resistant prostate cancer. In addition, germline testing may have screening implications for additional cancers for patients and cascade testing implications for family members. The data supporting when to perform repeat testing and optimal tissue type to use (eg, primary tumor v metastatic biopsy versus circulating tumor DNA [ctDNA] testing) are more limited, but this panel recommends considering retesting in patients whose results were previously negative or uninformative, and to consider either a metastatic biopsy or ctDNA when a significant change in clinical status occurs. Next-generation genomic sequencing findings that are associated with prognostic only (and not predictive) value should not be used to guide treatment outside of a clinical trial.Additional information is available at www.asco.org/genitourinary-cancer-guidelines.

ASCO Rapid Recommendation Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual . The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options. Guidelines and updates are not intended to substitute for independent professional judgment of the treating provider and do not account for individual variation among patients. See appendix for disclaimers and other important information (Appendix 1 and Appendix 2, online only).

Objective: Data extraction from the published literature is the most laborious step in conducting living systematic reviews (LSRs). We aim to build a generalizable, automated data extraction workflow leveraging large language models (LLMs) that mimics the real-world two-reviewer process., Materials and Methods: A dataset of 10 clinical trials (22 publications) from a published LSR was used, focusing on 23 variables related to trial, population, and outcomes data. The dataset was split into prompt development (n=5) and held-out test sets (n=17). GPT-4-turbo and Claude-3-Opus were used for data extraction. Responses from the two LLMs were compared for concordance. In instances with discordance, original responses from each LLM were provided to the other LLM for cross-critique. Evaluation metrics, including accuracy, were used to assess performance against the manually curated gold standard., Results: In the prompt development set, 110 (96%) responses were concordant, achieving an accuracy of 0.99 against the gold standard. In the test set, 342 (87%) responses were concordant. The accuracy of the concordant responses was 0.94. The accuracy of the discordant responses was 0.41 for GPT-4-turbo and 0.50 for Claude-3-Opus. Of the 49 discordant responses, 25 (51%) became concordant after cross-critique, with an increase in accuracy to 0.76., Discussion: Concordant responses by the LLMs are likely to be accurate. In instances of discordant responses, cross-critique can further increase the accuracy., Conclusion: Large language models, when simulated in a collaborative, two-reviewer workflow, can extract data with reasonable performance, enabling truly 'living' systematic reviews., Competing Interests: Irbaz bin Riaz, Muhammad Ali Khan, Umair Ayub, Syed Arsalan Ahmed Naqvi, Kaneez Zahra Rubab Khakwani, Zaryab bin Riaz Sipra, Ammad Raina, Sihan Zou, Huan He, Seyyed Amir Hossein, Hasan Bashar, R. Bryan Rumble, Jia Zou, Kenneth L. Kehl, Jeanne Palmer, M. Hassan Murad and Chitta Baral do not have any relevant competing interests to disclose. Danielle S. Bitterman (DSB): Editorial, unrelated to the submitted work: Associate Editor of Radiation Oncology, HemOnc.org (no financial compensation); Advisory and consulting, unrelated to the submitted work: MercurialAI Jeremy L. Warner (JLW): Reports funding from AACR, NIH, Brown Physicians Incorporated, unrelated to the submitted work; consulting with Wested and The Lewin Group, unrelated to the submitted work; ownership in HemOnc.org LLC, unrelated to the submitted work Amye J. Tevaarwerk (AJT): Family member at Epic Systems, unrelated to the submitted work Konstantinos Leventakos (KL): Reports consulting activities (honoraria to institution) with Amgen, AstraZeneca Interdisciplinary Corporation, Boehringer Ingelheim Pharmaceuticals, Janssen Biotech, Novartis, unrelated to the submitted work; advisory boards (honoraria to institution) with AstraZeneca, Janssen, Jazz Pharmaceuticals, Mirati Therapeutics, Regeneron, Takeda, and Targeted Oncology, unrelated to the submitted work; CME activities (honoraria to institution) with OncLive and MJH Life Sciences, MD Outlook and Targeted Oncology, unrelated to the submitted work; Research support (to institution) from AstraZeneca and Mirati Therapeutics, unrelated to the submitted work.

Context: There are several procedures for surgical nodal staging in clinically node-negative (cN0) penile carcinoma., Objective: To evaluate the diagnostic accuracy, perioperative outcomes, and complications of minimally invasive surgical procedures for nodal staging in penile carcinoma., Evidence Acquisition: A systematic review of the Medline, Embase, and Cochrane controlled trials databases and ClinicalTrials.gov was conducted. Published and ongoing studies reporting on the management of cN0 penile cancer were included without any design restriction. Outcomes included the false negative (FN) rate, the number of nodes removed, surgical time, and postoperative complications., Evidence Synthesis: Forty-one studies were eligible for inclusion. Four studies comparing robot-assisted (RA-VEIL) and video-endoscopic inguinal lymphadenectomy (VEIL) to open inguinal lymph node dissection (ILND) were suitable for meta-analysis. A descriptive synthesis was performed for single-arm studies on modified open ILND, dynamic sentinel node biopsy (DSNB) with and without preoperative inguinal ultrasound (US), and fine-needle aspiration cytology (FNAC). DSNB with US + FNAC had lower FN rates (3.5-22% vs 0-42.9%) and complication rates (Clavien Dindo grade I-II: 1.1-20% vs 2.9-11.9%; grade III-V: 0-6.8% vs 0-9.4%) in comparison to DSNB alone. Favourable results were observed for VEIL/RA-VEIL over open ILND in terms of major complications (2-10.6% vs 6.9-40.6%; odds ratio [OR] 0.18; p < 0.01). Overall, VEIL/RA-VEIL had lower wound-related complication rates (OR 0.14; p < 0.01), including wound infections (OR 0.229; p < 0.01) and skin necrosis (OR 0.16; p < 0.01). The incidence of lymphatic complications varied between 20.6% and 49%., Conclusions: Of all the surgical staging options, DSNB with inguinal US + FNAC had the lowest complication rates and high diagnostic accuracy, especially when performed in high-volume centres. If DSNB is not available, favourable results were also found for VEIL/RA-VEIL over open ILND. Lymphatic-related complications were comparable across open and video-endoscopic ILND., Patient Summary: We reviewed studies on different surgical approaches for assessing lymph node involvement in cases with penile cancer. The results show that a technique called dynamic sentinel node biopsy with ultrasound guidance and fine-needle sampling has high diagnostic accuracy and low complication rates. For lymph node dissection in penile cancer cases, a minimally invasive approach may offer favourable postoperative outcomes., (Copyright © 2023. Published by Elsevier B.V.)

ASCO Rapid Recommendation Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual . The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options. See the Appendix for disclaimers and other important information (Appendix 1 and Appendix 2, online only).

Context: Penile cancer is a rare disease but has a significant impact on quality of life. Its incidence is increasing, so it is important to include new and relevant evidence in clinical practice guidelines., Objective: To provide a collaborative guideline that offers worldwide physician and patient guidance for the management of penile cancer., Evidence Acquisition: Comprehensive literature searches were performed for each section topic. In addition, three systematic reviews were conducted. Levels of evidence were assessed, and a strength rating for each recommendation was assigned according to the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology., Evidence Synthesis: Penile cancer is a rare disease but its global incidence is increasing. Human papillomavirus (HPV) is the main risk factor for penile cancer and pathology should include an assessment of HPV status. The main aim of primary tumour treatment is complete tumour eradication, which has to be balanced against optimal organ preservation without compromising oncological control. Early detection and treatment of lymph node (LN) metastasis is the main determinant of survival. Surgical LN staging with sentinel node biopsy is recommended for patients with a high-risk (≥pT1b) tumour with cN0 status. While (inguinal) LN dissection remains the standard for node-positive disease, multimodal treatment is needed in patients with advanced disease. Owing to a lack of controlled trials and large series, the levels of evidence and grades of recommendation are low in comparison to those for more common diseases., Conclusions: This collaborative penile cancer guideline provides updated information on the diagnosis and treatment of penile cancer for use in clinical practice. Organ-preserving surgery should be offered for treatment of the primary tumour when feasible. Adequate and timely LN management remains a challenge, especially in advanced disease stages. Referral to centres of expertise is recommended., Patient Summary: Penile cancer is a rare disease that significantly impacts quality of life. While the disease can be cured in most cases without lymph node involvement, management of advanced disease remains challenging. Many unmet needs and unanswered questions remain, underlining the importance of research collaborations and centralisation of penile cancer services., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options.

ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options .

ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options., Competing Interests: Beverly MoyConsulting or Advisory Role: MOTUS (I)Research Funding: Puma Biotechnology (Inst) Lisa A. CareyResearch Funding: Syndax (Inst), Novartis (Inst), NanoString Technologies (Inst), Seattle Genetics (Inst), Veracyte (Inst), AstraZeneca (Inst)Patents, Royalties, Other Intellectual Property: Royalty-sharing agreement, investorship interest in licensed IP to startup company, Falcon Therapeutics, that is designing neural stem cell-based therapy for glioblastoma multiforme (I)Uncompensated Relationships: Novartis (Inst), G1 Therapeutics (Inst), Genentech/Roche (Inst), GlaxoSmithKline (Inst), AstraZeneca/Daiichi Sankyo (Inst), Exact Sciences (Inst), Eisai, Sanofi, Lilly, Seattle GeneticsOpen Payments Link: https://openpaymentsdata.cms.gov/physician/179671No other potential conflicts of interest were reported.

Purpose: To provide recommendations for the management of patients with metastatic clear cell renal cell carcinoma (ccRCC)., Methods: An Expert Panel conducted a systematic literature review to obtain evidence to guide treatment recommendations., Results: The panel considered peer-reviewed reports published in English., Recommendations: The diagnosis of metastatic ccRCC should be made using tissue biopsy of the primary tumor or a metastatic site with the inclusion of markers and/or stains to support the diagnosis. The International Metastatic RCC Database Consortium risk criteria should be used to inform treatment. Cytoreductive nephrectomy may be offered to select patients with kidney-in-place and favorable- or intermediate-risk disease. For those who have already had a nephrectomy, an initial period of active surveillance may be offered if they are asymptomatic with a low burden of disease. Patients with favorable-risk disease who need systemic therapy may be offered an immune checkpoint inhibitor (ICI) in combination with a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI); patients with intermediate or poor risk should be offered a doublet regimen (no recommendation was provided between ICIs or an ICI in combination with a VEGFR TKI). For select patients, monotherapy with either an ICI or a VEGFR TKI may be offered on the basis of comorbidities. Interleukin-2 remains an option, although selection criteria could not be identified. Recommendations are also provided for second- and subsequent-line therapy as well as the treatment of bone metastases, brain metastases, or the presence of sarcomatoid features. Participation in clinical trials is highly encouraged for patients with metastatic ccRCC.Additional information is available at www.asco.org/genitourinary-cancer-guidelines.

Context: The primary lesion in penile cancer is managed by surgery or radiation. Surgical options include penile-sparing surgery, amputative surgery, laser excision, and Moh's micrographic surgery. Radiation is applied as external beam radiotherapy (EBRT) and brachytherapy. The treatment aims to completely remove the primary lesion and preserve a sufficient functional penile stump., Objective: To assess whether the 5-yr recurrence-free rate and other outcomes, such as sexual function, quality of life, urination, and penile preserving length, vary between various treatment options., Evidence Acquisition: The EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane HTA, DARE, HEED), Google Scholar, and ClinicalTrials.gov were searched for publications from 1990 through May 2021. Randomized controlled trials, nonrandomized comparative studies (NRCSs), and case series (CSs) were included., Evidence Synthesis: The systematic review included 88 studies, involving 9578 men from 16 NRCSs and 72 CSs. The cumulative mean 5-yr recurrence-free rates were 82.0% for penile-sparing surgery, 83.9% for amputative surgery, 78.6% for brachytherapy, 55.2% for EBRT, 69.4% for lasers, and 88.2% for Moh's micrographic surgery, as reported from CSs, and 76.7% for penile-sparing surgery and 93.3% for amputative surgery, as reported from NRCSs. Penile surgery affects sexual function, but amputative surgery causes more appearance concerns. After brachytherapy, 25% of patients reported sexual dysfunction. Both penile-sparing surgery and amputative surgery affect all aspects of psychosocial well-being., Conclusions: Despite the poor quality of evidence, data suggest that penile-sparing surgery is not inferior to amputative surgery in terms of recurrence rates in selected patients. Based on the available information, however, broadly applicable recommendations cannot be made; appropriate patient selection accounts for the relative success of all the available methods., Patient Summary: We reviewed the evidence of various techniques to treat penile tumor and assessed their effectiveness in oncologic control and their functional outcomes. Penile-sparing as well as amputative surgery is an effective treatment option, but amputative surgery has a negative impact on sexual function. Penile-sparing surgery and radiotherapy are associated with a higher risk of local recurrence, but preserve sexual function and quality of life better. Laser and Moh's micrographic surgery could be used for smaller lesions., (© 2022 The Authors.)

Purpose: The increased number and expanded utilization of biosimilars raise important considerations for their safe and appropriate use in oncology practice. This report provides an update on currently approved oncology biosimilars and identifies current knowledge gaps in the management of patients with cancer., Methods: An Expert Panel was convened to review the medical literature and to provide a practical summary of currently approved biosimilar therapeutics for cancer treatment or supportive care in the United States., Results: A total of 17 cancer or cancer-related biosimilar products have been approved by the US Food and Drug Administration since 2015. Despite years of clinical experience with oncology biosimilars, variance in their use persists. ASCO supports that biosimilars and reference products are considered equally efficacious for the purpose of inclusion in ASCO clinical practice guideline recommendations., Conclusion: The use of biosimilars might provide competitive, lower-cost alternatives to biologics used in cancer care, and specific mention in ASCO guidelines and other evidence products is supported where appropriate., Competing Interests: Gary H. LymanConsulting or Advisory Role: G1 Therapeutics, Samsung Bioepis, BeyondSpring Pharmaceuticals, Sandoz, Jazz Pharmaceuticals, Partner Therapeutics, E.R. Squibb Sons, LLC, MSD, Seattle Genetics, Kallyope, TEVA, Spectrum Pharmaceuticals, Frensenius KabiResearch Funding: Amgen (Inst) Richard L. SchilskyLeadership: Clarified Precision MedicineConsulting or Advisory Role: Cellworks, Scandion Oncology, Bryologyx, Illumina, EQRxResearch Funding: AstraZeneca (Inst), Bayer (Inst), Bristol Myers Squibb (Inst), Genentech/Roche (Inst), Lilly (Inst), Merck (Inst), Pfizer (Inst), Boehringer Ingelheim (Inst), Seattle Genetics (Inst)Open Payments Link: https://openpaymentsdata.cms.gov/physician/1138818/summary Douglas E. PetersonStock and Other Ownership Interests: Allergan (I), Celgene (I), Gilead Sciences (I), Procter & Gamble (I), Roche (I), Bristol Myers Squibb (I), Johnson & Johnson (I)Honoraria: PierianDxConsulting or Advisory Role: Amgen, PSI Pharma Support America, Applied Glycan-Oral Health, AEC Partners, BrainCool, Medicxi Ventures (UK) LLP, Boston MedTech Advisors Scott T. TagawaConsulting or Advisory Role: Medivation, Astellas Pharma, Dendreon, Janssen, Genentech, Endocyte, Immunomedics, Karyopharm Therapeutics, AbbVie, Tolmar, QED Therapeutics, Amgen, Sanofi, Pfizer, Clovis Oncology, Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics, Seattle Genetics, AIkido Pharma, 4D Pharma, Clarity Pharmaceuticals, Gilead Sciences, Telix Pharmaceuticals, Bayer, Myovant Sciences, Convergent TherapeuticsResearch Funding: Lilly (Inst), Sanofi (Inst), Janssen (Inst), Astellas Pharma (Inst), Progenics (Inst), Millennium (Inst), Amgen (Inst), Bristol Myers Squibb (Inst), Dendreon (Inst), Rexahn Pharmaceuticals (Inst), Bayer (Inst), Genentech (Inst), Newlink Genetics (Inst), Inovio Pharmaceuticals (Inst), AstraZeneca (Inst), Immunomedics (Inst), Novartis (Inst), AVEO (Inst), Boehringer Ingelheim (Inst), Merck (Inst), Stem CentRx (Inst), Karyopharm Therapeutics (Inst), AbbVie (Inst), Medivation (Inst), Endocyte (Inst), Exelixis (Inst), Clovis Oncology (Inst), POINT Biopharma (Inst)Patents, Royalties, Other Intellectual Property: Patent Royalty from Immunomedics/GileadTravel, Accommodations, Expenses: Sanofi, Immunomedics, AmgenUncompensated Relationships: ATLAB Pharma, Phosplatin Therapeutics Mariana Chavez-MacGregorEmployment: MD Anderson Physicians NetworkHonoraria: Pfizer, EisaiConsulting or Advisory Role: Roche/Genentech, AstraZeneca, Novartis, Pfizer, asofar, Genomic Health, Exact Sciences, AstraZeneca/Daiichi SankyoResearch Funding: Novartis (Inst)Expert Testimony: Abbott Laboratories, PfizerTravel, Accommodations, Expenses: PfizerOther Relationship: RocheUncompensated Relationships: Legacy Healthcare Services, The Hope FoundationNo other potential conflicts of interest were reported.