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

doi:10.1136/jitc-2021-002552

. 2021 Jul;9(7):e002552.

doi: 10.1136/jitc-2021-002552.

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

Matthew D Galsky¹, Arjun V Balar², Peter C Black³, Matthew T Campbell⁴, Gail S Dykstra^{5

6}, Petros Grivas^{7

8}, Shilpa Gupta⁹, Christoper J Hoimes¹⁰, Lidia P Lopez¹¹, Joshua J Meeks^{12

13}, Elizabeth R Plimack¹⁴, Jonathan E Rosenberg^{15

16}, Neal Shore¹⁷, Gary D Steinberg¹⁸, Ashish M Kamat¹⁹

Affiliations

¹ Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
² Perlmutter Cancer Center, New York University Langone Medical Center, New York, New York, USA.
³ Department of Urologic Sciences, The University of British Columbia, Vancouver, British Columbia, Canada.
⁴ Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
⁵ Bladder Cancer Advocacy Network (BCAN), Bethesda, Maryland, USA.
⁶ Dykstra Research, Seattle, Washington, USA.
⁷ Department of Medicine, Division of Oncology, University of Washington, Seattle, Washington, USA.
⁸ Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
⁹ Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.
¹⁰ Department of Medicine, Duke Cancer Institute, Duke University, Durham, North Carolina, USA.
¹¹ Division of Hematology-Oncology, Department of Medicine, University of California Los Angeles, Los Angeles, California, USA.
¹² Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹³ The Jesse Brown VA Medical Center, Chicago, Illinois, USA.
¹⁴ Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
¹⁵ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
¹⁶ Deparment of Medicine, Weill Cornell Medical College, New York, New York, USA.
¹⁷ Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA.
¹⁸ Department of Urology and Perlmutter Cancer Center, NYU Langone Medical Center, New York, New York, USA.
¹⁹ Department of Urology under Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA akamat@mdanderson.org.

PMID: 34266883
PMCID: PMC8286774
DOI: 10.1136/jitc-2021-002552

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

Matthew D Galsky et al. J Immunother Cancer. 2021 Jul.

. 2021 Jul;9(7):e002552.

doi: 10.1136/jitc-2021-002552.

Authors

Affiliations

¹ Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
² Perlmutter Cancer Center, New York University Langone Medical Center, New York, New York, USA.
³ Department of Urologic Sciences, The University of British Columbia, Vancouver, British Columbia, Canada.
⁴ Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
⁵ Bladder Cancer Advocacy Network (BCAN), Bethesda, Maryland, USA.
⁶ Dykstra Research, Seattle, Washington, USA.
⁷ Department of Medicine, Division of Oncology, University of Washington, Seattle, Washington, USA.
⁸ Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
⁹ Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.
¹⁰ Department of Medicine, Duke Cancer Institute, Duke University, Durham, North Carolina, USA.
¹¹ Division of Hematology-Oncology, Department of Medicine, University of California Los Angeles, Los Angeles, California, USA.
¹² Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹³ The Jesse Brown VA Medical Center, Chicago, Illinois, USA.
¹⁴ Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.
¹⁵ Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
¹⁶ Deparment of Medicine, Weill Cornell Medical College, New York, New York, USA.
¹⁷ Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA.
¹⁸ Department of Urology and Perlmutter Cancer Center, NYU Langone Medical Center, New York, New York, USA.
¹⁹ Department of Urology under Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA akamat@mdanderson.org.

PMID: 34266883
PMCID: PMC8286774
DOI: 10.1136/jitc-2021-002552

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.

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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.

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[1] Siegel RL, Miller KD, Fuchs HE, et al. . Cancer statistics, 2021. CA Cancer J Clin 2021;71:7–33. 10.3322/caac.21654 - DOI - PubMed

[2] Siegel RL, Miller KD, Fuchs HE, et al. . Cancer statistics, 2021. CA Cancer J Clin 2021;71:7–33. 10.3322/caac.21654 - DOI - PubMed

[3] Wołącewicz M, Hrynkiewicz R, Grywalska E, et al. . Immunotherapy in bladder cancer: current methods and future perspectives. Cancers 2020;12:1181. 10.3390/cancers12051181 - DOI - PMC - PubMed

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[8] Food and Drug Administration, EMD Serono . BAVENCIO prescribing information. Available: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview...

[9] Food and Drug Administration, Genentech Inc . TECENTRIQ prescribing information. Available: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview...

[10] Food and Drug Administration, Genentech Inc . TECENTRIQ prescribing information. Available: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview...

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

Affiliations

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

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