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. 2021 Aug;9(8):e002597.
doi: 10.1136/jitc-2021-002597.

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

Leisha A Emens  1 , Sylvia Adams  2 , Ashley Cimino-Mathews  3 , Mary L Disis  4 , Margaret E Gatti-Mays  5 , Alice Y Ho  6 , Kevin Kalinsky  7 , Heather L McArthur  8 , Elizabeth A Mittendorf  9   10 , Rita Nanda  11 , David B Page  12 , Hope S Rugo  13 , Krista M Rubin  14 , Hatem Soliman  15 , Patricia A Spears  16 , Sara M Tolaney  17 , Jennifer K Litton  18
Affiliations

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

Leisha A Emens et al. J Immunother Cancer. 2021 Aug.

Erratum in

Abstract

Breast cancer has historically been a disease for which immunotherapy was largely unavailable. Recently, the use of immune checkpoint inhibitors (ICIs) in combination with chemotherapy for the treatment of advanced/metastatic triple-negative breast cancer (TNBC) has demonstrated efficacy, including longer progression-free survival and increased overall survival in subsets of patients. Based on clinical benefit in randomized trials, ICIs in combination with chemotherapy for the treatment of some patients with advanced/metastatic TNBC have been approved by the United States (US) Food and Drug Administration (FDA), expanding options for patients. Ongoing questions remain, however, about the optimal chemotherapy backbone for immunotherapy, appropriate biomarker-based selection of patients for treatment, the optimal strategy for immunotherapy treatment in earlier stage disease, and potential use in histological subtypes other than TNBC. To provide guidance to the oncology community on these and other important concerns, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline (CPG). The expert panel drew upon the published literature as well as their clinical experience to develop recommendations for healthcare professionals on these important aspects of immunotherapeutic treatment for breast cancer, including diagnostic testing, treatment planning, immune-related adverse events (irAEs), and patient quality of life (QOL) considerations. The evidence-based and consensus-based recommendations in this CPG are intended to give guidance to cancer care providers treating patients with breast cancer.

Keywords: breast neoplasms; clinical trials as topic; guidelines as topic; immunotherapy.

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Conflict of interest statement

Competing interests: SA–Contracted research: Funding to institution from Amgen, Bristol Myers Squibb, Merck, Celgene, Roche. AC-M–Consulting fees: Bristol Myers Squibb, Roche Diagnostics; Contracted research: Bristol Myers Squibb; Partner Salary: Vivante Health; Royalty: Springer/Demos Publishing-Textbooks. MLD–Contracted research: Pfizer, EMD Serono, Bavarian Nordisk, Precigen, Epithany, Silverback Therapeutics, Celgene; IP Rights: University of Washington; Non-CME Services: SITC; Ownership interest: Epithany; Partner ownership interest: Epithany; Partner salary: Cox Cable; Royalty: University of Washington; Salary: University of Washington. LAE–Contracted research: Aduro Biotech, AstraZeneca, Bristol Myers Squibb, Corvus, EMD Serono, Genentech, F Hoffman La Roche, Maxcyte, Merck, Tempest, Silverback, Bolt, Compugen, Takeda, CytomX; Consulting fees: Genentech, F Hoffman La Roche, Syndax, Lilly, AbbVie, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Celgene, Chugai, F Hoffman La Roche, GCPR, Genentech, Gilead, Gritstone, Medimmune, Macrogenics, Novartis, Peregrine, Replimune, Shionogi, Silverback, Vaccinex; IP Rights: Aduro Biotech; Royalty: Elsevier; Salary: University of Pittsburgh, UPMC UPP; Grants from non-industry entities: HeritX Incorporated, NSABP Foundation, Translational Breast Cancer Research Consortium, Breast Cancer Research Foundation, National Cancer Institute, Department of Defense, Johns Hopkins University, University of California San Francisco, Cornell University; Ownership interest: Molecuvax-potential for royalties in the future. MG-M–Trial funding to institution: EMD Serono (OSU Site PI). AYH–Consulting fees: Seattle Genetics; La Roche-Posay; Contracted research: Merck and GSK. KK–Consulting fees: Eli Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Merck, Seattle Genetics; Contracted research: Incyte, Genentech, Eli Lilly, Pfizer, Calithera Biosciences, Acetylon, Seattle Genetics, Amgen, ZenoPharmaceuticals, CytomX Therapeutics; Partner Salary: Pfizer, Array Biopharma - no longer employee at either; Speaker Bureau: Eli Lilly. JKL–Contracted research: Novartis, Medivation/Pfizer, Genentech, GSK, EMD Serono, AstraZeneca, Medimmune, Zenith, Jounce (All were payments to my Institution of for writing support for manuscripts of multicenter trials. No payments directly to Dr Litton); Consulting fees: Pfizer/Medivation, AstraZeneca, Ayala (All honorariums were refused); Salary: The University of Texas MD Anderson Cancer Center. HLM–Consulting fees: Bristol Myers Squibb, Eli Lilly, Genentech/Roche, Merck, Pfizer, Puma, Daiichi Sankyo, Seattle Genetics, AstraZeneca; Contracted Research: Bristol Myers Squibb, MedImmune, LLC/AstraZeneca, BTG, Merck. EAM–Consulting fees: Merck, Genomic Health, Roche/Genentech; Contracted research: GlaxoSmithKline; NPI: 1831388596. RN–Consulting fees: Clovis, Immunomedics, Macrogenics, Merck, Pfizer, Seattle Genetics; Contracted research: AstraZeneca, Celgene, Corcept Therapeutics, Genentech/Roche, Immunomedics, Merck, OBI Pharma, Odonate Therapeutics, Pfizer, Seattle Genetics; DSMB: G1 Therapeutics. DBP–Consulting fees: Genentech, Merck, Brooklyn Immunotherapeutics; Contracted research: Merck, Brooklyn Immunotherapeutics, Bristol Myers Squibb; Speaker bureau: Genentech, Novartis. HSR–Consulting fees: Puma, Samsung - Limited consulting; Contracted research: Pfizer, Merck, Novartis, Lilly, Genentech, OBI, Odonate, Daiichi, Seattle Genetics, Eisai, Macrogenics, Immunomedics; Travel support for educational programs: Daiichi, Mylan, Pfizer, Merck, AstraZeneca, Novartis, Macrogenics. KMR–Consulting fees: Merck, Bristol Myers Squibb, Eisai. HS–Consulting fees: AstraZeneca, Eisai, Novartis, Celgene, PUMA, Seattle Genetics. PAS–Consulting fees: Pfizer. SMT–Consulting fees: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech, Immunomedics, Bristol Myers Squibb, Eisai, Nanostring, Puma, Sanofi, Celldex, Paxman, Odonate, Seattle Genetics, Silverback Therapeutics, G1 Therapeutics, AbbVie, Anthenex, Oncopep; Contracted research: AstraZeneca, Eli Lilly, Merck, Nektar, Novartis, Pfizer, Genentech, Immunomedics, Bristol Myers Squibb, Eisai, Nanostring, Sanofi, Exelisis, Seattle Genetics, Cyclacel, Odonate. SITC Staff: SMW—Shares owned: Pacific Biosciences of California, Editas Medicine. EG, AK, LL—Nothing to disclose.

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