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

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.

Keywords: Clinical Trials as Topic; Genital Neoplasms, Female; Guidelines as Topic.

Figure 1

Immune biomarker testing for gynecologic cancer. The VENTANA MMR IHC assay is the FDA-approved companion diagnostic for determining MMR status for treatment with dostarlimab or pembrolizumab. The FoundationOne CDx is approved as a companion diagnostic for assaying MSI-H and TMB-H status for pembrolizumab treatment. The PD-L1 IHC 22C3 pharmDx assay is approved for measuring PD-L1 expression for the pembrolizumab indication in cervical cancer. dMMR, mismatch repair deficient; IHC, immunohistochemistry; MSI-H, high microsatellite instability; NGS, next-generation sequencing; PD-L1, programmed death-ligand 1; TMB-H, high tumor mutational burden.

Figure 2

Advanced cervical cancer diagnostic workup and treatment algorithm. For all patients with cervical cancer, clinical trial enrolment should be encouraged, as feasible. CPS, combined positive score; PD-L1, programmed death-ligand 1; SOC, standard of care

Figure 3

Advanced endometrial cancer diagnostic workup and treatment algorithm. For all patients with endometrial cancer, clinical trial enrolment should be encouraged, as feasible. For patients with HER2+ serous endometrial cancer, carboplatin plus paclitaxel and trastuzumab is also a treatment option. *Excluding prior chemotherapy given in the neoadjuvant or adjuvant setting; †Following prior systemic therapy in any setting including the neoadjuvant or adjuvant setting. dMMR, mismatch repair deficient; HER2, human epidermal growth factor receptor 2; MMR, mismatch repair; MSI-H, high microsatellite instability; MSS, microsatellite stable; pMMR, mismatch repair proficient.