NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Penile Cancer Version 2.2019 — May 13, 2019 NCCN.org Continue Version 2.2019, 05/13/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 2.2019 Table of Contents Penile Cancer Discussion *Thomas W. Flaig, MD †/Chair Harry W. Herr, MD ϖ Sumanta K. Pal, MD † University of Colorado Cancer Center Memorial Sloan Kettering Cancer Center City of Hope National Medical Center *Philippe E. Spiess, MD, MS ϖ/Vice Chair Christopher Hoimes, MD † Anthony Patterson, MD ϖ Moffitt Cancer Center Case Comprehensive Cancer Center/ St. Jude Children’s Research Hospital/ University Hospitals Seidman Cancer Center The University of Tennessee Neeraj Agarwal, MD ‡ † and Cleveland Clinic Taussig Cancer Institute Health Science Center Huntsman Cancer Institute at the University of Utah Brant A. Inman, MD, MSc ϖ Elizabeth R. Plimack, MD, MS † Duke Cancer Institute Fox Chase Cancer Center Rick Bangs, MBA Patient Advocate Masahito Jimbo, MD, PhD, MPH Þ Kamal S. Pohar, MD ϖ University of Michigan Rogel Cancer Center The Ohio State University Comprehensive Stephen A. Boorjian, MD ϖ Cancer Center - James Cancer Hospital Mayo Clinic Cancer Center A. Karim Kader, MD, PhD ϖ and Solove Research Institute UC San Diego Moores Cancer Center Mark K. Buyyounouski, MD, MS § Michael P. Porter, MD, MS ϖ Stanford Cancer Institute Subodh M. Lele, MD ≠ Fred Hutchinson Cancer Research Center/ Fred & Pamela Buffett Cancer Center Sam Chang, MD ¶ Seattle Cancer Care Alliance Vanderbilt-Ingram Cancer Center Joshua J. Meeks, MD, PhD ϖ Mark A. Preston, MD, MPH ϖ Robert H. Lurie Comprehensive Cancer Tracy M. Downs, MD ϖ Dana-Farber/Brigham and Women’s Center of Northwestern University University of Wisconsin Cancer Center Carbone Cancer Center Jeff Michalski, MD, MBA § Wade J. Sexton, MD ϖ Siteman Cancer Center at Barnes- Jason A. Efstathiou, MD, DPhil § Moffitt Cancer Center Jewish Hospital and Washington Massachusetts General Hospital University School of Medicine Arlene O. Siefker-Radtke, MD † Cancer Center The University of Texas Jeffrey S. Montgomery, MD, MHSA ϖ Terence Friedlander, MD † MD Anderson Cancer Center University of Michigan Rogel Cancer Center UCSF Helen Diller Family Jonathan Tward, MD, PhD § Comprehensive Cancer Center Lakshminarayanan Nandagopal, MD † Huntsman Cancer Institute O'Neal Comprehensive Cancer Center at UAB Richard E. Greenberg, MD ϖ at the University of Utah Fox Chase Cancer Center Lance C. Pagliaro, MD † NCCN Mayo Clinic Cancer Center Khurshid A. Guru, MD ϖ Lisa Gurski, PhD Roswell Park Comprehensive Cancer Center Alyse Johnson-Chilla, MS ‡ Hematology/Hematology § Radiotherapy/Radiation Continue oncology oncology NCCN Guidelines Panel Disclosures Þ Internal medicine ¶ Surgery/Surgical Oncology † Medical oncology ϖ Urology ≠ Pathology * Discussion writing committee member Version 2.2019, 05/13/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 2.2019 Table of Contents Penile Cancer Discussion NCCN Penile Cancer Panel Members Clinical Trials: NCCN believes that Summary of the Guidelines Updates the best management for any patient with cancer is in a clinical trial. Participation in clinical trials is Primary Evaluation, Clinical Diagnosis (PN-1) especially encouraged. Primary Treatment Tis, Ta (PN-1) To find clinical trials online at NCCN Primary Treatment T1, T2 or Greater (PN-2) Member Institutions, click here: Management of Non-Palpable Inguinal Lymph Nodes (PN-3) nccn.org/clinical_trials/clinicians.aspx. Management of Palpable Non-Bulky Inguinal Lymph Nodes (PN-4) NCCN Categories of Evidence and Consensus: All recommendations Management of Palpable Bulky Inguinal Lymph Nodes (PN-5) are category 2A unless otherwise Management of Enlarged Pelvic Lymph Nodes (PN-6) indicated. Surveillance Schedule (PN-7) See NCCN Categories of Evidence Management of Recurrent Disease (PN-8) and Consensus. Management of Metastatic Disease (PN-9) NCCN Categories of Preference: All recommendations are considered appropriate. Principles of Penile Organ-Sparing Approaches (PN-A) See NCCN Categories of Preference Principles of Surgery (PN-B) Principles of Radiotherapy (PN-C) Principles of Systemic Therapy (PN-D) Staging (ST-1) The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2019. Version 2.2019, 05/13/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 2.2019 Table of Contents Penile Cancer Discussion Updates in Version 2.2019 of the NCCN Guidelines for Penile Cancer from Version 1.2019 include: MS-1 • The discussion section has been updated to reflect the changes in the algorithm. Updates in Version 1.2019 of the NCCN Guidelines for Penile Cancer from Version 2.2018 include: Global Changes • The NCCN Categories of Preference have been applied to all systemic therapy treatment recommendations. INTRO • This is a new page. PN-2 • T1, Grade 1-2 Primary Treatment: "Partial penectomy" added as an option. PN-5 • Top pathway, percutaneous lymph node biopsy positive treatment recommendations updated: " Consider Cisplatin-based neoadjuvant chemotherapy followed by ILND or ILND (in patients not eligible for cisplatin-based chemotherapy)" PN-8 • Top pathway: Invasion of corpora cavernosa absent or present removed and changed to "Noninvasive" or "Invasive" Principles of Penile Organ-Sparing Approaches PN-A (1 of 2) • Laser therapy 3rd bullet updated: "A plume (smoke) evacuator is recommended required during penile laser treatments..." • Spot size in commonly used settings row of the table updated: CO2: "Spot size: 3 mm 1–5 mm" Nd:YAG: "Spot size: 5 mm 1–5 mm" Principles of Systemic Therapy (PN-D) • Name of page was changed from "Principles of Chemotherapy" to "Principles of Systemic Therapy" • These pages were extensively revised to apply the NCCN Categories of Preference. Version 2.2019, 05/13/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. UPDATES NCCN Guidelines Index NCCN Guidelines Version 2.2019 Table of Contents Penile Cancer Discussion INTRODUCTION NCCN and the NCCN Penile Cancer Panel believes that the best management for any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged. Version 2.2019, 05/13/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. INTRO NCCN Guidelines Index NCCN Guidelines Version 2.2019 Table of Contents Penile Cancer Discussion PRIMARY EVALUATION CLINICAL PRIMARY TREATMENT DIAGNOSIS See a Management of Topical therapy Non-Palpable or a Inguinal Lymph Wide local excision Nodes (PN-3) or Laser therapya (category 2B) Tis or Ta or H&P Complete glansectomya (category 2B) • Risk factors or See Balanitis, chronic inflammation, Mohs surgery in select casesa Management of penile trauma, lack of neonatal (category 2B) Palpable Inguinal circumcision, tobacco use, Lymph Nodes lichen sclerosus, poor hygiene, (PN-4) sexually transmitted disease • Lesion characteristics Suspicious Diameter, location, number of penile lesion lesions, morphology (papillary, nodular, ulcerous, or flat), relationship to other structures (submucosal, corpora spongiosa, cavernosa, and/or urethra) Cytology or histologic diagnosis • Punch, excisional, or incisional biopsy ≥T1 See Primary Treatment (PN-2) If recurrent disease, see PN-8 or if metastatic disease, see PN-9 a See Principles of Penile Organ-Sparing Approaches (PN-A). Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any patient with cancer is in a clinical trial. Participation in clinical trials is especially encouraged. Version 2.2019, 05/13/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. PN-1 NCCN Guidelines Index NCCN Guidelines Version 2.2019 Table of Contents Penile Cancer Discussion PATHOLOGIC DIAGNOSIS PRIMARY TREATMENT Wide local excisiona or