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

Ann W. Silk; Christopher A. Barker; Shailender Bhatia; Kathryn B. Bollin; Sunandana Chandra; Zeynep Eroglu; Brian R. Gastman; Kari L. Kendra; Harriet Kluger; Evan J. Lipson; Kathleen Madden; David M. Miller; Paul Nghiem; Anna C. Pavlick; Igor Puzanov; Guilherme Rabinowits; Emily S. Ruiz; Vernon K. Sondak; Edward A. Tavss; Michael T. Tetzlaff; Isaac Brownell

doi:10.1136/jitc-2021-004434

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

Ann W. Silk^*, Christopher A. Barker, Shailender Bhatia, Kathryn B. Bollin, Sunandana Chandra, Zeynep Eroglu, Brian R. Gastman, Kari L. Kendra, Harriet Kluger, Evan J. Lipson, Kathleen Madden, David M. Miller, Paul Nghiem, Anna C. Pavlick, Igor Puzanov, Guilherme Rabinowits, Emily S. Ruiz, Vernon K. Sondak, Edward A. Tavss, Michael T. TetzlaffIsaac Brownell^*

^*Corresponding author for this work

Medicine, Hematology Oncology Division

Research output: Contribution to journal › Article › peer-review

17 Scopus citations

Abstract

Nonmelanoma skin cancers (NMSCs) are some of the most commonly diagnosed malignancies. In general, early-stage NMSCs have favorable outcomes; however, a small subset of patients develop resistant, advanced, or metastatic disease, or aggressive subtypes that are more challenging to treat successfully. Recently, immune checkpoint inhibitors (ICIs) have been approved by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma (MCC), cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC). Although ICIs have demonstrated activity against NMSCs, the routine clinical use of these agents may be more challenging due to a number of factors including the lack of predictive biomarkers, the need to consider special patient populations, the management of toxicity, and the assessment of atypical responses. With the goal of improving patient care by providing expert guidance to the oncology community, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew on the published literature as well as their own clinical experience to develop recommendations for healthcare professionals on important aspects of immunotherapeutic treatment for NMSCs, including staging, biomarker testing, patient selection, therapy selection, post-treatment response evaluation and surveillance, and patient quality of life (QOL) considerations, among others. The evidence- and consensus-based recommendations in this CPG are intended to provide guidance to cancer care professionals treating patients with NMSCs.

Original language	English (US)
Article number	e004434
Journal	Journal for immunotherapy of cancer
Volume	10
Issue number	7
DOIs	https://doi.org/10.1136/jitc-2021-004434
State	Published - Jul 28 2022

Funding

The financial support for the development of this guideline was provided solely by SITC. No commercial funding was received. CAB: consulting fees: Regeneron; contracted research: Alpha Tau Medical, Merck, Amgen, Elekta, and EMD Serono. SB: consulting fees: Genentech, Bristol Myers Squibb, EMD Serono, Sanofi Genzyme, and Exicure; contracted research: Bristol Myers Squibb, EMD Serono, Immune Design, Merck, Novartis, Oncosec, Nantkwest, Exicure, and Nektar. KBB: consulting fees: Iovance Biotherapeutics and Nektar Therapeutics. SC: consulting fees: Bristol Myers Squibb, Regeneron, Sanofi Genzyme, Novartis, EMD Serono, Exicure, and Pfizer; contracted research: Bristol Myers Squibb, Merck, Regeneron, Sanofi Genzyme, Novartis, EMD Serono, Exicure, and Pfizer. ZE: consulting fees: Regeneron, Genentech, Novartis, Natera, Pfizer, and OncoSec (advisory boards); research funding (to institution): Pfizer and Novartis. BRG: consulting fees: Quest Imaging (consultant/advisor) and Castle Biosciences (speaker); contracted research: NIT and Alkermes (research grant). KLK: contracted research: Merck, Bristol Myers Squibb, Karyopharm, Novartis, GlaxoSmithKline, Immunocore, and Iovance. HK: consulting fees: Nektar, Roche-Genentech, Pfizer, Iovance, Immunocore, Celldex, Array Biopharma, Merck, Elevate Bio, Instil Bio, and Bristol Myers Squibb; contracted research: Merck, Bristol Myers Squibb, and Apexigen (institutional research grants (to institution)). EJL: consulting fees: Array BioPharma, Bristol Myers Squibb, Eisai, EMD Serono, Genentech, MacroGenics, Novartis, Merck, Odonate Therapeutics, OncoSec, Regeneron, and Sanofi Genzyme; contracted research: Bristol Myers Squibb, Merck, and Regeneron. KM: consulting fees: Pfizer (advisory board). DMM: consulting fees: Sanofi, Regeneron, Intellisphere LLC, OncLive, and Checkpoint Therapeutics; ownership interest: Checkpoint Therapeutics. PN: consulting fees: EMD Serono, Pfizer, 4SC, Wolters Kluwer Health, Merck, Sanofi Genzyme, and Regeneron; contracted research: EMD Serono and Bristol Myers Squibb; other: secretary–treasurer for Society of Investigative Dermatology; partner consulting fees: Pfizer and Kadmon; partner contracted research: Millenium Pharmaceuticals, Amgen, Novartis, Kadmon, Pfizer, Syndax Pharmaceuticals, and Incyte; partner other: President of American Society of Hematology. ACP: consulting fees: Regeneron, Bristol Myers Squibb, and Merck; fees for non-CE services: Bristol Myers Squibb; contracted research: Merck, Bristol Myers Squibb, Iovance, Regeneron, Takeda, Ideaya, and Replimune (all payments to institution). IP: consulting fees: Merck, Amgen, Nouscom, Nektar, and Iovance; other: Bristol Myers Squibb (medical writing/article processing charges); ownership interest: Celldex. GR: consulting fees: Sanofi Genzyme, Regeneron, EMD Serono, Pfizer, Castle, and Merck; ownership interest: Regeneron and Syros Pharmaceuticals. ESR: consulting fees: Sanofi, Leo Pharma, Checkpoint Therapeutics, Pellepharm, and Jounce. AWS: consulting fees: Bristol Myers Squibb, Merck, and EMD Serono. VKS: consulting fees: Merck, Regeneron, and Eisai; other: Bristol Myers Squibb and Polynoma (data safety monitoring boards). MTT: consulting fees: Nanostring LLC, Bristol Myers Squibb, Merck, Myriad Genetics, and Seattle Genetics. EAT: nothing to disclose. IB: Nothing to disclose. Society for Immunotherapy of Cancer (SITC) staff: SMW - shares owned: Pacific Biosciences of California Inc and Editas Medicine Inc; ME, CG, EG, and AK - nothing to disclose.

Keywords

clinical trials as topic
guidelines as topic
immunotherapy
skin neoplasms

ASJC Scopus subject areas

Immunology and Allergy
Immunology
Molecular Medicine
Oncology
Pharmacology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/jitc-2021-004434

Cite this

Silk, A. W., Barker, C. A., Bhatia, S., Bollin, K. B., Chandra, S., Eroglu, Z., Gastman, B. R., Kendra, K. L., Kluger, H., Lipson, E. J., Madden, K., Miller, D. M., Nghiem, P., Pavlick, A. C., Puzanov, I., Rabinowits, G., Ruiz, E. S., Sondak, V. K., Tavss, E. A., ... Brownell, I. (2022). Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer. Journal for immunotherapy of cancer, 10(7), Article e004434. https://doi.org/10.1136/jitc-2021-004434

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title = "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer",

abstract = "Nonmelanoma skin cancers (NMSCs) are some of the most commonly diagnosed malignancies. In general, early-stage NMSCs have favorable outcomes; however, a small subset of patients develop resistant, advanced, or metastatic disease, or aggressive subtypes that are more challenging to treat successfully. Recently, immune checkpoint inhibitors (ICIs) have been approved by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma (MCC), cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC). Although ICIs have demonstrated activity against NMSCs, the routine clinical use of these agents may be more challenging due to a number of factors including the lack of predictive biomarkers, the need to consider special patient populations, the management of toxicity, and the assessment of atypical responses. With the goal of improving patient care by providing expert guidance to the oncology community, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew on the published literature as well as their own clinical experience to develop recommendations for healthcare professionals on important aspects of immunotherapeutic treatment for NMSCs, including staging, biomarker testing, patient selection, therapy selection, post-treatment response evaluation and surveillance, and patient quality of life (QOL) considerations, among others. The evidence- and consensus-based recommendations in this CPG are intended to provide guidance to cancer care professionals treating patients with NMSCs.",

keywords = "clinical trials as topic, guidelines as topic, immunotherapy, skin neoplasms",

author = "Silk, {Ann W.} and Barker, {Christopher A.} and Shailender Bhatia and Bollin, {Kathryn B.} and Sunandana Chandra and Zeynep Eroglu and Gastman, {Brian R.} and Kendra, {Kari L.} and Harriet Kluger and Lipson, {Evan J.} and Kathleen Madden and Miller, {David M.} and Paul Nghiem and Pavlick, {Anna C.} and Igor Puzanov and Guilherme Rabinowits and Ruiz, {Emily S.} and Sondak, {Vernon K.} and Tavss, {Edward A.} and Tetzlaff, {Michael T.} and Isaac Brownell",

note = "Publisher Copyright: {\textcopyright} ",

year = "2022",

month = jul,

day = "28",

doi = "10.1136/jitc-2021-004434",

language = "English (US)",

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Silk, AW, Barker, CA, Bhatia, S, Bollin, KB, Chandra, S, Eroglu, Z, Gastman, BR, Kendra, KL, Kluger, H, Lipson, EJ, Madden, K, Miller, DM, Nghiem, P, Pavlick, AC, Puzanov, I, Rabinowits, G, Ruiz, ES, Sondak, VK, Tavss, EA, Tetzlaff, MT & Brownell, I 2022, 'Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer', Journal for immunotherapy of cancer, vol. 10, no. 7, e004434. https://doi.org/10.1136/jitc-2021-004434

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T1 - Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of nonmelanoma skin cancer

AU - Silk, Ann W.

AU - Barker, Christopher A.

AU - Bhatia, Shailender

AU - Bollin, Kathryn B.

AU - Chandra, Sunandana

AU - Eroglu, Zeynep

AU - Gastman, Brian R.

AU - Kendra, Kari L.

AU - Kluger, Harriet

AU - Lipson, Evan J.

AU - Madden, Kathleen

AU - Miller, David M.

AU - Nghiem, Paul

AU - Pavlick, Anna C.

AU - Puzanov, Igor

AU - Rabinowits, Guilherme

AU - Ruiz, Emily S.

AU - Sondak, Vernon K.

AU - Tavss, Edward A.

AU - Tetzlaff, Michael T.

AU - Brownell, Isaac

PY - 2022/7/28

Y1 - 2022/7/28

N2 - Nonmelanoma skin cancers (NMSCs) are some of the most commonly diagnosed malignancies. In general, early-stage NMSCs have favorable outcomes; however, a small subset of patients develop resistant, advanced, or metastatic disease, or aggressive subtypes that are more challenging to treat successfully. Recently, immune checkpoint inhibitors (ICIs) have been approved by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma (MCC), cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC). Although ICIs have demonstrated activity against NMSCs, the routine clinical use of these agents may be more challenging due to a number of factors including the lack of predictive biomarkers, the need to consider special patient populations, the management of toxicity, and the assessment of atypical responses. With the goal of improving patient care by providing expert guidance to the oncology community, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew on the published literature as well as their own clinical experience to develop recommendations for healthcare professionals on important aspects of immunotherapeutic treatment for NMSCs, including staging, biomarker testing, patient selection, therapy selection, post-treatment response evaluation and surveillance, and patient quality of life (QOL) considerations, among others. The evidence- and consensus-based recommendations in this CPG are intended to provide guidance to cancer care professionals treating patients with NMSCs.

AB - Nonmelanoma skin cancers (NMSCs) are some of the most commonly diagnosed malignancies. In general, early-stage NMSCs have favorable outcomes; however, a small subset of patients develop resistant, advanced, or metastatic disease, or aggressive subtypes that are more challenging to treat successfully. Recently, immune checkpoint inhibitors (ICIs) have been approved by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma (MCC), cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC). Although ICIs have demonstrated activity against NMSCs, the routine clinical use of these agents may be more challenging due to a number of factors including the lack of predictive biomarkers, the need to consider special patient populations, the management of toxicity, and the assessment of atypical responses. With the goal of improving patient care by providing expert guidance to the oncology community, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew on the published literature as well as their own clinical experience to develop recommendations for healthcare professionals on important aspects of immunotherapeutic treatment for NMSCs, including staging, biomarker testing, patient selection, therapy selection, post-treatment response evaluation and surveillance, and patient quality of life (QOL) considerations, among others. The evidence- and consensus-based recommendations in this CPG are intended to provide guidance to cancer care professionals treating patients with NMSCs.

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

Abstract

Funding

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ASJC Scopus subject areas

UN SDGs

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