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

Sep 24, 2026

Uploaded by James

Advanced gynecologic cancers have historically had limited effective treatment options. Immune checkpoint inhibitors (ICIs) have been approved for cervical and endometrial cancer, with durable responses for some patients, while additional immunotherapy approaches are being studied for earlier stages and other gynecologic malignancies. Improved outcomes with ICIs require careful biomarker testing, treatment selection, patient selection, response evaluation, surveillance, and attention to patient quality of life. To provide evidence- and consensus-based guidance, SITC convened a multidisciplinary expert panel to develop this clinical practice guideline.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages34

Reading Time1 h 26 min

AccessFree to download

ABSTRACT

INTRODUCTION

GUIDELINE DEVELOPMENT METHODS

Expert Panel composition

Open access Position article and guidelines Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gynecologic cancer Mary L Disis ,1 Sarah F Adams,2 Jyoti Bajpai ,3,4 Marcus O Butler,5 Tyler Curiel ,6 Shelley A Dodt,7 Laura Doherty,8 Leisha A Emens ,9 Claire F Friedman ,10,11 Margaret Gatti-Mays ,12 Melissa A Geller ,13 Amir Jazaeri ,14 Veena S John ,15 Katherine C Kurnit ,16 John B Liao ,17 Haider Mahdi,18 Anne Mills,19 Emese Zsiros ,20 Kunle Odunsi 21 To cite: Disis ML, Adams SF, Bajpai J, et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gynecologic cancer. Journal for ImmunoTherapy of Cancer 2023;11:e006624 . doi:10.1136/jitc-2022-006624 Accepted 28 April 2023 © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. For numbered affiliations see end of article. Correspondence to Dr Kunle Odunsi; [odunsia@bsd.uchicago.edu](odunsia@bsd.uchicago.edu) ABSTRACT Advanced gynecologic cancers have historically lacked effective treatment options. Recently, immune checkpoint inhibitors (ICIs) have been approved by the US Food and Drug Administration for the treatment of cervical cancer and endometrial cancer, offering durable responses for some patients. In addition, many immunotherapy strategies are under investigation for the treatment of earlier stages of disease or in other gynecologic cancers, such as ovarian cancer and rare gynecologic tumors. While the integration of ICIs into the standard of care has improved outcomes for patients, their use requires a nuanced understanding of biomarker testing, treatment selection, patient selection, response evaluation and surveillance, and patient quality of life considerations, among other topics. To address this need for guidance, the Society for Immunotherapy of Cancer (SITC) convened a multidisciplinary panel of experts to develop a clinical practice guideline. The Expert Panel drew on the published literature as well as their own clinical experience to develop evidence-and consensus-based recommendations to provide guidance to cancer care professionals treating patients with gynecologic cancer. INTRODUCTION Gynecologic cancer causes a significant global health burden for people assigned female at birth,1 even with advances in prevention such as vaccination against the human papillomavirus (HPV)—the main etiological agent of cervical, vaginal, and vulvar cancers.2 Recurrent or metastatic gynecologic cancer, especially of the cervix, endometrium, or ovary, has historically been associated with poor prognosis and limited treatment options that often elicit significant toxicities. In recent years, immune checkpoint inhibitors (ICIs) antagonizing programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) (collectively referred to in this clinical practice guideline [CPG] as PD-(L)1) have improved outcomes in numerous cancers either as monotherapies or in combination with chemotherapy, tumor-targeted therapies, or other ICIs. These regimens disrupt suppressive signaling in the tumor microenvironment such that tumor antigen-specific T cells may efficiently eradicate cancer cells and initiate subsequent cycles of antigen presentation, T cell priming, trafficking and infiltration, and recognition of tumor antigens by effector cells.3 Many features of gynecologic cancer—including elevated PD-L1 expression, pathogenic mutations in DNA polymerase epsilon (POLE) with accompanying ultra-mutated tumor mutational burden (TMB), intercurrent HPV infections, presence of tumor infiltrating lymphocytes (TILs), and high penetrance of mismatch repair (MMR) deficiency (dMMR)—suggest the presence of pre-existing anti-tumor immunity that may beamenable to re-invigoration through immunotherapy.4 As such, ICIs have demonstrated clinical benefi

FAQs

Why was this SITC clinical practice guideline developed for gynecologic cancer immunotherapy?

The guideline addresses the need for guidance on integrating ICIs, which requires nuanced understanding of biomarker testing, treatment and patient selection, response evaluation, surveillance, and quality-of-life considerations. SITC convened a multidisciplinary expert panel to produce evidence- and consensus-based recommendations for clinicians treating patients with gynecologic cancer.

Which immune checkpoint targets are referenced in the guideline introduction?

The introduction focuses on immune checkpoint inhibitors that antagonize programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1), collectively referred to as PD-(L)1 in the clinical practice guideline.

What factors are described as important for identifying patients who may benefit from ICIs?

Biomarkers are emphasized as crucial because not all gynecologic tumors respond. The text highlights features such as elevated PD-L1 expression, pathogenic POLE mutations with ultra-mutated tumor mutational burden (TMB), intercurrent HPV infections, tumor-infiltrating lymphocytes (TILs), and mismatch repair deficiency (dMMR).

How does the guideline position its recommendations regarding clinical decision-making?

The document states that the SITC provided CPGs are intended to assist providers and do not mandate a specific course of treatment or medical care. It also notes that recommendations are voluntary and that the physician makes the final determination based on each patient’s individual circumstances.

Sep 24, 2026

Uploaded by James