SITC Breast Cancer Immunotherapy Guideline

SITC's Cancer Immunotherapy Guidelines program is a collection of clinical practice guidelines (CPGs) developed by multi-disciplinary panels of experts who draw from their own practical experience as well as evidence in the published literature and clinical trial data to develop evidence- and consensus-based recommendations. SITC uses as a model the Institute of Medicine's 2011 "Standards for Developing Trustworthy Clinical Practice Guidelines" to ensure recommendations are unbiased, transparent, and balanced. 

The breast cancer guideline provides a valuable clinical decision-making tool to help guide oncologists and other advanced practice providers on topics including biomarkers, the selection of appropriate immunotherapeutic regimens, treatment response and monitoring, toxicity management, and patient quality of life considerations. 

Published Guideline

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Updated Content (last reviewed 3/15/24)
In accordance with the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines, SITC CPGs undergo periodic evaluation to assess if new evidence necessitates modifications to recommendations, treatment algorithms, or other guideline content. This is done through our “SITC Living Guidelines” rapid update protocols designed to ensure SITC CPGs are up-to-date with cutting-edge thinking and incorporate the leading expert guidance in cancer immunotherapy care – a vital service to treating clinicians and those along the whole cancer care continuum. 

The information below provides an overview of the updates made to the "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of breast cancer" since its publication in Journal for ImmunoTherapy of Cancer (JITC).  

Rapid Update v1.2 Summary

• The FDA granted accelerated approval for dostarlimab for the treatment of dMMR recurrent or advanced solid tumors (along with the VENTANA MMR RxDx Panel companion diagnostic to detect dMMR) that have progressed on or following prior treatment and who have no satisfactory alternative treatment options on August 17, 2021. Based on these approvals, the Breast Cancer CPG has been updated in the following locations: "Immunotherapy with PD-(L)1 Inhibitors for the Treatment of Advanced/Metastatic Breast Cancer" and "Diagnostics and Biomarker Testing in Patients with Advanced/Metastatic Breast Cancer." Additionally, Table 2 was updated from the original publication to include the GARNET trial data that led to the tissue-agnostic dostarlimab approval.
  
• The FoundationOne CDx assay was approved as the companion diagnostic for identifying patients with MSI-H tumors for treatment with pembrolizumab in February 2022. Based on this approval, the Breast Cancer CPG has been updated in the following location: "Diagnostics and Biomarker Testing in Patients with Advanced/Metastatic Breast Cancer." 

Addendum v1.1 Summary 

• On August 27, 2021, the indication for atezolizumab in combination with nab-paclitaxel as treatment for patients with triple-negative breast cancer (TNBC) whose tumors express PD-L1 was voluntarily withdrawn by the manufacturer. According to the press release announcing the withdrawal, the decision was not related to any changes in either the efficacy or safety associated with atezolizumab but rather to recent changes in the treatment landscape for TNBC. In light of this withdrawal, updates were made to narrative text and recommendations within the Breast Cancer CPG. 

Download the app for quick access to the breast cancer CPG with interactive tools and companion education resources.

Guideline Education

SITC is pleased to offer companion education resources in support of the breast cancer CPG. These activities feature faculty comprised of the guideline Expert Panel and are designed to provide a deeper understanding of the recommendations in the SITC guidelines and how to apply them in various clinical scenarios.  The education available features both webinars that take a deeper look at the guideline recommendations and mini-module videos on a specific topic within the guideline content. Below is a list of the available educational resources for this CPG, available free and on-demand.

Webinars:

• Immunotherapy for the Treatment of Breast Cancer CPG Overview
  • Leading experts in cancer immunotherapy present an overview of the "Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of breast cancer."
    

• Practical Management Pearls for Immunotherapy for the Treatment of Breast Cancer
  • This one hour on-demand webinar features members of the guideline Expert Panel. These faculty members discuss how to appraise and classify organ-specific considerations for immunotherapy agents and toxicities, identify and manage clinically significant uncommon toxicities, and determine optimal sequencing of immunotherapies in relapsed and/or refractory disease.

• Case Studies in Immunotherapy for the Treatment of Breast Cancer
  • This one hour on-demand webinar features members of the guideline Expert Panel. These faculty members discuss case studies that illustrate execution of SITC guideline recommendations, as well as discussion on difficult topics related to case management.

Mini-Modules:

• First-Line Treatment of Metastatic TNBC
  • Expert Panel member Heather McArthur, MD, MPH, provides a thorough description of studies supporting current recommendations for treatment of metastatic, triple negative breast cancer.  Details of PD-L1 testing in advanced/metastatic breast cancer are also discussed.

• Neoadjuvant and Adjuvant Treatment
  • Expert Panel member Kevin Kalinsky, MD, MS, discusses data supporting the use of neoadjuvant chemotherapy with immune checkpoint inhibitors for treatment of triple negative breast cancer.  Ongoing investigations on the efficacy of adjuvant chemotherapy in combination with immune checkpoint inhibitors are also addressed. 

• Toxicities and Adverse Events
  • Expert Panel members provide an overview of immune-related adverse events and toxicities. Case presentations underscore the importance of vigilance, early intervention, and a multi-disciplinary approach when managing toxicities and adverse events in patients receiving immunotherapy for triple negative breast cancer. 

For questions regarding SITC CPGs, please contact a member of the Scientific Publications Department at scientificresources@sitcancer.org.