{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["14"],"submitter":["Schwab R"],"pubmed_abstract":["<h4>Introduction</h4>Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic modalities, such as extensive surgical resection, chemotherapy, and radiotherapy. The most important emerging treatment modalities are immune checkpoint inhibitors. This systematic review and meta-analysis aims to assess the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, in women with advanced vulvar cancer.<h4>Materials and methods</h4>Following a comprehensive search, review, and appraisal, two relevant single-arm studies were included. Meta-analysis was conducted using R4.3.0 software and RStudio 2023.03.0, presenting the overall effect size with a 95% confidence interval. Heterogeneity was assessed using I<sup>2</sup> and the Cochrane Q χ2 statistics.<h4>Results</h4>Out of 154 studies screened for eligibility, two single-arm studies involving 119 patients receiving pembrolizumab for advanced vulvar cancer were included. The pooled objective response rate (ORR) was overall 10% (95% CI: 0.00-0.84) and 9% (95% CI: 0.00-0.89) in the PD-L1 positive subgroup. In the intention-to-treat (ITT) population, 31% (95% CI: 0.04-0.85) exhibited any clinical benefit (complete response, partial response, or stable disease). In the ITT population at six months, progression-free survival (PFS) was 19% (95% CI: 0.01-0.82), and overall survival (OS) was 48% (95% CI: 0.08-0.90). At 12 months, PFS decreased to 9% (95% CI: 0.00-0.85), and OS was 33% (95% CI: 0.04-0.85). No statistically significant heterogeneity was observed in PFS and OS analyses.<h4>Discussion and conclusion</h4>This study suggests that one-third of women with advanced or recurrent vulvar cancer may, without the influence of PD-L1 status, benefit from pembrolizumab treatment despite a decline in both PFS and OS at 12 months. These findings provide support for considering pembrolizumab in the treatment paradigm for this specific subset of cancer patients.<h4>Systematic review registration</h4>https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888."],"journal":["Frontiers in oncology"],"pagination":["1352975"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10910062"],"repository":["biostudies-literature"],"pubmed_title":["Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis."],"pmcid":["PMC10910062"],"pubmed_authors":["Schmidt M","Klecker PH","Hasenburg A","Schiestl LJ","Cascant Ortolano L","Heimes AS","Brenner W","Almstedt K","Schmidt MW","Stewen K","Schwab R"],"additional_accession":[]},"is_claimable":false,"name":"Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis.","description":"<h4>Introduction</h4>Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic modalities, such as extensive surgical resection, chemotherapy, and radiotherapy. The most important emerging treatment modalities are immune checkpoint inhibitors. This systematic review and meta-analysis aims to assess the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, in women with advanced vulvar cancer.<h4>Materials and methods</h4>Following a comprehensive search, review, and appraisal, two relevant single-arm studies were included. Meta-analysis was conducted using R4.3.0 software and RStudio 2023.03.0, presenting the overall effect size with a 95% confidence interval. Heterogeneity was assessed using I<sup>2</sup> and the Cochrane Q χ2 statistics.<h4>Results</h4>Out of 154 studies screened for eligibility, two single-arm studies involving 119 patients receiving pembrolizumab for advanced vulvar cancer were included. The pooled objective response rate (ORR) was overall 10% (95% CI: 0.00-0.84) and 9% (95% CI: 0.00-0.89) in the PD-L1 positive subgroup. In the intention-to-treat (ITT) population, 31% (95% CI: 0.04-0.85) exhibited any clinical benefit (complete response, partial response, or stable disease). In the ITT population at six months, progression-free survival (PFS) was 19% (95% CI: 0.01-0.82), and overall survival (OS) was 48% (95% CI: 0.08-0.90). At 12 months, PFS decreased to 9% (95% CI: 0.00-0.85), and OS was 33% (95% CI: 0.04-0.85). No statistically significant heterogeneity was observed in PFS and OS analyses.<h4>Discussion and conclusion</h4>This study suggests that one-third of women with advanced or recurrent vulvar cancer may, without the influence of PD-L1 status, benefit from pembrolizumab treatment despite a decline in both PFS and OS at 12 months. These findings provide support for considering pembrolizumab in the treatment paradigm for this specific subset of cancer patients.<h4>Systematic review registration</h4>https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024","modification":"2026-06-16T04:50:41.577Z","creation":"2025-04-19T22:02:21.935Z"},"accession":"S-EPMC10910062","cross_references":{"pubmed":["38440225"],"doi":["10.3389/fonc.2024.1352975"]}}