Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events

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.

Section: Toxicity Considerations: Patient Selection and Managementmentioning

confidence: 99%

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

Emens

Adams

Cimino‐Mathews

et al. 2021

“…For instance, the first line of treatment for irAEs is often corticosteroids. 14 While the impact of low-dose corticosteroids is still debated, glucocorticosteroids present at the time of treatment initiation and high-dose corticosteroids may mitigate ICB therapy 38 even though they may be mandatory for management of life-threatening severe toxicities. 14 Open access understanding of patient responses to ICB therapy and biomarkers of the potential for irAE development, will be essential for developing targeted immunotherapy that maximizes the anticancer response while minimizing immunotoxicity.…”

Section: Critical Questions For Understanding and Treating Immunotoxicitiesmentioning

confidence: 99%

“…13 Not surprisingly, irAEs are treated with many of the same therapeutic interventions as primary autoimmune diseases, including glucocorticosteroids and biological agents that are immunosuppressive or anti-inflammatory. 14 Immuno-oncology remains a rapidly developing field and it is estimated that there are many more coinhibitory pathways beyond CTLA-4 and PD-1 that could be valuable therapeutic targets. In fact, the future of cancer immunotherapy likely lies in combination therapy to increase antitumor responses, 15 16 which will likely also drive the development of novel irAEs and the need for new strategies to identify and mitigate these immune toxicities while maintaining effective antitumor immunity.…”

mentioning

confidence: 99%

Development of preclinical and clinical models for immune-related adverse events following checkpoint immunotherapy: a perspective from SITC and AACR

Bayless

Bluestone

Bucktrout

et al. 2021

Recent advances in cancer immunotherapy have completely revolutionized cancer treatment strategies. Nonetheless, the increasing incidence of immune-related adverse events (irAEs) is now limiting the overall benefits of these treatments. irAEs are well-recognized side effects of some of the most effective cancer immunotherapy agents, including antibody blockade of the cytotoxic T-lymphocyte-associated protein 4 and programmed death protein 1/programmed-death ligand 1 pathways. To develop an action plan on the key elements needed to unravel and understand the key mechanisms driving irAEs, the Society for Immunotherapy for Cancer and the American Association for Cancer Research partnered to bring together research and clinical experts in cancer immunotherapy, autoimmunity, immune regulation, genetics and informatics who are investigating irAEs using animal models, clinical data and patient specimens to discuss current strategies and identify the critical next steps needed to create breakthroughs in our understanding of these toxicities. The genetic and environmental risk factors, immune cell subsets and other key immunological mediators and the unique clinical presentations of irAEs across the different organ systems were the foundation for identifying key opportunities and future directions described in this report. These include the pressing need for significantly improved preclinical model systems, broader collection of biospecimens with standardized collection and clinical annotation made available for research and integration of electronic health record and multiomic data with harmonized and standardized methods, definitions and terminologies to further our understanding of irAE pathogenesis. Based on these needs, this report makes a set of recommendations to advance our understanding of irAE mechanisms, which will be crucial to prevent their occurrence and improve their treatment.

“…Given the potential risks associated with ICI treatment, several groups have developed suggested guidelines for the work up and management of suspected irAEs, including the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO), and SITC. [124][125][126][127][128] While the incidence and severity of irAEs may vary depending on the specific ICI used 129 or on the tumor type being treated, the treatment of urothelial cancer with ICIs has not been shown to carry any risks above baseline for the incidence or severity of irAEs. 130 Panel recommendation ► SITC's guidelines for the management of ICIrelated AEs should be consulted for the treatment of irAEs in patients with bladder cancer.…”

Section: Recognition and Management Of Iraesmentioning

confidence: 99%

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

Galsky

Balar

Black

et al. 2021

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.