Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer

Matthew D Galsky, Arjun V Balar, Peter C Black, Matthew T Campbell, Gail S Dykstra, Petros Grivas, Shilpa Gupta, Christoper J Hoimes, Lidia P Lopez, Joshua J Meeks, Elizabeth R Plimack, Jonathan E Rosenberg, Neal Shore, Gary D Steinberg, Ashish M Kamat, Matthew D Galsky, Arjun V Balar, Peter C Black, Matthew T Campbell, Gail S Dykstra, Petros Grivas, Shilpa Gupta, Christoper J Hoimes, Lidia P Lopez, Joshua J Meeks, Elizabeth R Plimack, Jonathan E Rosenberg, Neal Shore, Gary D Steinberg, Ashish M Kamat

Abstract

A number of immunotherapies have been developed and adopted for the treatment of urothelial cancer (encompassing cancers arising from the bladder, urethra, or renal pelvis). For these immunotherapies to positively impact patient outcomes, optimal selection of agents and treatment scheduling, especially in conjunction with existing treatment paradigms, is paramount. Immunotherapies also warrant specific and unique considerations regarding patient management, emphasizing both the prompt identification and treatment of potential toxicities. In order to address these issues, the Society for Immunotherapy of Cancer (SITC) convened a panel of experts in the field of immunotherapy for urothelial cancer. The expert panel developed this clinical practice guideline (CPG) to inform healthcare professionals on important aspects of immunotherapeutic treatment for urothelial cancer, including diagnostic testing, treatment planning, immune-related adverse events (irAEs), and patient quality of life (QOL) considerations. The evidence- and consensus-based recommendations in this CPG are intended to give guidance to cancer care providers treating patients with urothelial cancer.

Keywords: antineoplastic protocols; guidelines as topic; immunotherapy; urinary bladder neoplasms; urologic neoplasms.

Conflict of interest statement

Competing interests: AVB─Consulting fees: Genentech, Incyte, Janssen, Merck, Pfizer, AstraZeneca, Nektar, Seattle Genetics, DragonFly Therapeutics; Non-CME services: Genentech, AstraZeneca, Merck, Seattle Genetics; Contracted research: Genentech, Merck, AstraZeneca, Nektar, Seattle Genetics, Immunomedics. PCB─Consulting fees: AbbVie, Asieris Pharmaceuticals, Astellas, AstraZeneca, Bayer, Biosyent, Bristol-Myers Squibb, EMD Serono, Ferring, Fergene, H3 Biomedicine, Janssen, Merck, Roche, Sanofi, TerSera, Urogen; Contracted research: iProgen. MTC─Consulting fees: Pfizer, EMD Serono, AstraZeneca, Exelixis, Eisai, Seattle Genetics, Astellas; Contracted research: Exelixis, Pfizer/EMD Serono, Janssen, Apricity Health. GSD─Participant/unpaid volunteer: HealthVibe focus group 2020. MDG─Consulting fees: Inovio, NuMab, Janssen, Merck, GlaxoSmithKline, Genentech, Bristol-Myers Squibb, Seattle Genetics, Dracen, Dragonfly, Astellas, Novartis, Pfizer, AstraZeneca, Incyte, Dendreon, Eli Lilly, EMD Serono, Aileron Therapeutics; Ownership interest: Rappta Therapeutics; NPI: 1639140668. PG─Consulting fees: AstraZeneca, Dyania Health, EMD Serono, Immunomedics, Janssen, Merck, Mirati Therapeutics, Genentech, Pfizer, Seattle Genetics; Contracted Research: Bavarian Nordic, Bristol-Myers Squibb, Clovis Oncology, Debiopharm, Immunomedics, Pfizer, Merck, QED Therapeutics, GlaxoSmithKline, Kure It Cancer Research, Mirati Therapeutics. SG─Consulting fees: Merck, Bristol-Myers Squibb, Janssen, Seattle Genetics, AstraZeneca; Contracted research: Bristol-Myers Squibb, Pfizer; Non-CME services: Exelixis. CJH─Consulting fees: Astellas, Bristol-Myers Squibb, Genentech, Merck, Eisai, Seattle Genetics, 2bPrecise; Non-CME services: Astellas, Bristol-Myers Squibb, Genentech, Eisai, Seattle Genetics. AMK─Consulting fees: Abbott Molecular, Arquer, ArTara, Asieris, AstraZeneca, BioClin Therapeutics, Bristol-Myers Squibb, Cepheid, Cold Genesys, Eisai, Engene, Inc., Ferring, FerGene, Imagin, Janssen, MDxHealth, Medac, Merck, Pfizer, Photocure, ProTara, Roviant, Seattle Genetics, Sessen Bio, Theralase, TMC Innovation, US Biotest; Contracted research: Adolor, Bristol-Myers Squibb, FKD Industries, Heat Biologics, Merck, Photocure, SWOG/NIH, SPORE, AIBCCR; Clinical trials: FKD, Merck, Bristol-Myers Squibb, Photocure, SWOG, Adolor, Heat Biologics; Laboratory research: NIH, SPORE, AIBCCR; Educational grant: CEC Oncology; Editorial board: European Urology Oncology; Journal of Urology, UroToday; President of organization: International Bladder Cancer Network (IBCN), International Bladder Cancer Group (IBCG); IP Rights: CyPRIT (Cytokine Predictors of Response to Intravesical Therapy) Joint with UT MD Anderson Cancer Center. LPL─Consulting fees: Pfizer Advisory Nursing board, 2018; Lecture/Speaker/Expert Panel: ASCO Bladder Program 2019, Pfizer learning day 2019, ASCO Bladder Program Panel Member and Faculty 2019, Pfizer Learning Day Speaker 2019, BCAN Webinar Faculty 11/2020. JJM─Consulting fees: AstraZeneca, Ferring, Janssen, Nucleix, Foundation Medicine; Contracted research: Epizyme, Tesaro, Abbvie; Teaching an endoscopy course: Olympus. ERP─Consulting fees: AstraZeneca, Infinity Pharma, Pfizer, Flatiron, Genentech, Merck, Seattle Genetics; Contracted research: Astellas, Bristol-Myers Squibb, Genentech, Merck. JER─Consulting fees: Merck, Bristol-Myers Squibb, AstraZeneca, Astellas, Seattle Genetics, Boehringer Ingelheim, Bayer, Pfizer, Roche/Genentech, Mirati, QED Therapeutics, Janssen, Pharmacyclics, GlaxoSmithKline; Contracted research/Clinical trial funding: Seattle Genetics, Astellas, Roche/Genentech, Bayer, AstraZeneca, QED Therapeutics. NS─Consulting fees: Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Dendreon, Fergene, Ferring, Janssen, Merck, Myovant, Nymox, Pfizer, Sanofi/Genzyme, Sesen Bio, Sun Pharma, Tolmar. GDS─Consulting fees: Merck, Janssen, Ferring, Bristol-Myers Squibb, Pfizer, Genentech, Epivax Oncology, AstraZeneca, Fidia, Cold Genesys, EnGene Bio, Aduro Biotech, Dendreon, FKD Therapies, CiClomed, Seattle Genetics, Urogen, PhotoCure. SITC staff: SMW—Shares owned: Pacific Biosciences, Editas Medicine; EG, AK, BL, LL─Nothing to disclose.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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