Professional Standards

SITC holds the unique privilege of serving as an honest broker for the immunotherapy field. In addition to a growing portfolio of immunotherapy-specific clinical practice guidelines and the only-of-its-kind immunotherapy certificate program, the SITC Board of Directors annually selects areas in the field in need of consensus or standardization. In 2023, SITC published numerous manuscripts focused on consensus definitions for resistance, bladder cancer clinical trial design, and irAE terminology. The SITC Board of Directors welcomes consensus topic proposals from the SITC membership biannually.

Cancer Immunotherapy Guidelines Program

The SITC Cancer Immunotherapy Guidelines (CIG) 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 on when and how to use immunotherapy to help improve outcomes for patients
with cancer.

LIVING GUIDELINES

Through a collaboration with the society’s journal, JITC, the SITC CIG Program launched the “living guidelines” as a means to provide rapid updates to the original guideline publication. This is made possible through a new overlay technology that provides timely and transparent information related to the new and updated expert panel recommendations.

The SITC CPGs distill the published literature and the best clinical judgment of the expert panel into practical, actionable recommendations to help cancer care providers develop immunotherapy treatment plans for their patients. SITC has published CPGs covering a variety of hematologic malignancies, solid tumors, and toxicity management.


Clinical Practice Guidelines

In 2023, SITC published four new or updated guidelines on the following disease areas:

Gastrointestinal Cancer v1.0

Ronan J. Kelly, MB BCh, MBA
Baylor University Medical Center
Co-Chair

Dung Le, MD
Johns Hopkins University School of Medicine
Co-Chair

Gynecologic Cancer v1.0

Mary L. Disis, MD, FACP
University of Washington
Co-Chair

Adekunle Odunsi, MD, PhD
University of Chicago Medicine
Co-Chair

Hepatocellular Carcinoma v1.1 Addenda

Tim F. Greten, MD
National Institutes of Health
Co-Chair

Ignacio Melero, MD, PhD
FIMA
Co-Chair

Melanoma v3.0

Anna C. Pavlick, DO, MBA
New York University Cancer Institute
Co-Chair

Ryan J. Sullivan, MD
Massachusetts General Hospital
Co-Chair


CPG Companion Education

SITC offers free live and on-demand companion educational resources in support of the published CPGs. These activities are designed to provide a deeper understanding of the recommendations in the SITC guidelines and how to apply them in various clinical scenarios. In 2023, SITC produced:

  • Six CPG webinars
  • Three CPG mini modules

Certificate in Cancer Immunotherapy

SITC offers physicians and qualified healthcare providers the only opportunity to earn a Certificate in Cancer Immunotherapy, supporting their knowledge and skills to provide effective and safe cancer immunotherapy treatment for patients. Learners can develop a comprehensive understanding of cancer immunotherapies, including checkpoint inhibitors, cell therapies and many others, as well as the management of side effects, allowing them to successfully implement immunotherapy in clinical practice.

Resistance Manuscripts

With a view toward accelerating drug development, SITC convened the "Combination Immunotherapy Resistance Workshop" to build on past efforts to reach consensus on definitions of IO resistance in the monotherapy setting. Broadening the effort to cover combinatory approaches further advanced SITC’s vision for uptake of the proposed standards. Consensus resistance definitions from the workshop were published in the Journal for ImmunoTherapy of Cancer (JITC) via three manuscripts, with one focusing on resistance to immunotherapy combinations, another on immunotherapy in combination with chemotherapy, and the third highlighting immunotherapy in combination with targeted therapies.

Consensus Definitions for Immune Checkpoint Inhibitor-Related Adverse Events Terminology

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of several solid tumors, providing deep and durable responses for many patients. However, the anti-tumor mechanism of action of ICIs can also cause aberrantly active self-damaging immune responses, leading to immune-related adverse events (irAEs). The natural history, response to treatment, and patterns of irAEs vary widely, ranging from short-term inflammatory conditions to prolonged inflammation and damage to organs leading to permanent dysfunction. These diverse patterns of irAEs have been inconsistently described in the literature, making existing data difficult to interpret.

Recognizing a need for a generally accepted and shared vocabulary for irAEs, SITC convened an international consensus panel comprised of leading experts from academic medicine, industry, and regulatory agencies to develop definitions and uniform terminology for irAE natural history (i.e., re-emergent, chronic-active, chronic-inactive, delayed/late-onset), response to treatment (i.e., steroid-unresponsive, steroid-dependent), and patterns (i.e., multisystem irAEs).

The result of this effort was a manuscript, “Society for Immunotherapy of Cancer (SITC) consensus definitions for immune checkpoint inhibitor-associated immune-related adverse events (irAEs) terminology,” available in the Journal for ImmunoTherapy of Cancer (JITC), the society’s open-access, peer-reviewed online journal.

Bladder Cancer Clinical Trial Design

SITC and the International Bladder Cancer Group (IBCG) published, “Definitions, End Points, and Clinical Trial Designs for Bladder Cancer: Recommendations From the Society for Immunotherapy of Cancer and the International Bladder Cancer Group,” in the Journal of Clinical Oncology. These recommendations provide a detailed clinical trial design guide to maximize the chance of capturing the benefit of medical therapies for each unique stage of bladder cancer, from low-risk non-muscle invasive bladder cancer to metastatic disease.

SITC and IBCG formed a partnership to develop Expert Panel recommendations in response to a significant unmet need that still exists for standardized trials designed for new urothelial carcinoma treatments specific to stage and treatment approach. In the manuscript, the Expert Panel discusses standardization of key clinical design elements to identify optimal treatment options and improve outcomes for patients. By providing standardized criteria, the paper also aims to benefit the field by allowing cancer researchers to develop more comparable and robust data sets for meta-analyses.