Table 1.
Studies and case reports exploring the role of Immune checkpoint inhibitors (ICIs) in recurrent/advanced vulvar cancers (VCs).
| Type of Study | Antibody | Clinical Setting | Number of Patients | Outcomes | Reference |
|---|---|---|---|---|---|
| KEYNOTE-028 Non-randomized, multicenter, multicohort phase Ib trial |
Pembrolizumab (PD-1 inhibitor) | Avanced tumors | 18 VSCC out of 474 tumors | PFS was 20% and 7% at 6 and 12 months; OS rate was 42% and 28% at 6 and 12 months |
Ott et al. [104] |
| CheckMate 358 trial Phase I-II study |
Nivolumab (PD-1 inhibitor) |
Metastatic/recurrent tumors | 19 cervical tumors, 5 vulvar/vaginal tumors | In vulvar/vaginal cohort: OS was 40% and 20% at 12-month and 18 month OS; PFS was 40% at 6 months |
Naumann et al. [105] |
| Case report | Pembrolizumab (PD-1 inhibitor) | Recurrent VC with PD-L1 and PD-1 mutation | 1 | Near CR at 6 months of treatrment | Shields et al. [106] |
| Single-arm phase II clinical study | Pembrolizumab (PD-1 inhibitor) | Unoperable locally advanced or metastatic tumors | Recruiting. Target enrollement: 24 patients. | Primary endpoint: 95% CI for ORR. Secondary endopint: RFS-6 |
Yeku et al. [107] |
| Retrospective series | Anti-CTLA-4 | Metastatic vulvar-vaginal melanomas | 6 | 33% survival rate at 1 year | Quéreux et al. [109] |
| Open-label, phase II basket trial | Pembrolizumab (PD-1 inhibitor) | Recurrent small cell NET | 6 cervical, 1 vulvar NETs | Median OS not achieved (18.8-not reached) OS 84.6% at 6 months |
Strosberg et al. [110] |
Abbreviations: CR: complete response; CTLA-4: cytotoxic T-lymphocyte-associated protein 4; ICIs: immune checkpoint inhibitors; NET: neuroendocrine tumors; OS: overall survival; PD-1 programmed death 1; PD-L1: programmed death ligand 1; PFS: progression-free survival; VC: vulvar cancer; VSCC: vulvar squamous cell carcinoma.