Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis
IntroductionVulvar 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...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2024-02-01
|
| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2024.1352975/full |
| _version_ | 1797303309768327168 |
|---|---|
| author | Roxana Schwab Lina Judit Schiestl Lorena Cascant Ortolano Philip Herbert Klecker Mona Wanda Schmidt Katrin Almstedt Anne-Sophie Heimes Walburgis Brenner Kathrin Stewen Marcus Schmidt Annette Hasenburg |
| author_facet | Roxana Schwab Lina Judit Schiestl Lorena Cascant Ortolano Philip Herbert Klecker Mona Wanda Schmidt Katrin Almstedt Anne-Sophie Heimes Walburgis Brenner Kathrin Stewen Marcus Schmidt Annette Hasenburg |
| author_sort | Roxana Schwab |
| collection | DOAJ |
| description | IntroductionVulvar 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.Materials and methodsFollowing 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 I2 and the Cochrane Q χ2 statistics.ResultsOut 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.Discussion and conclusionThis 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.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023391888 |
| first_indexed | 2024-03-07T23:51:00Z |
| format | Article |
| id | doaj.art-54a202f43ba5407589087b76f8360978 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-03-07T23:51:00Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-54a202f43ba5407589087b76f83609782024-02-19T04:56:09ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2024-02-011410.3389/fonc.2024.13529751352975Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysisRoxana Schwab0Lina Judit Schiestl1Lorena Cascant Ortolano2Philip Herbert Klecker3Mona Wanda Schmidt4Katrin Almstedt5Anne-Sophie Heimes6Walburgis Brenner7Kathrin Stewen8Marcus Schmidt9Annette Hasenburg10Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartmental Library, University Medical Center Mainz, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, GermanyIntroductionVulvar 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.Materials and methodsFollowing 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 I2 and the Cochrane Q χ2 statistics.ResultsOut 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.Discussion and conclusionThis 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.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023391888https://www.frontiersin.org/articles/10.3389/fonc.2024.1352975/fullvulvar cancerPD-L1PD-1pembrolizumabimmune checkpoint inhibitormeta-analysis |
| spellingShingle | Roxana Schwab Lina Judit Schiestl Lorena Cascant Ortolano Philip Herbert Klecker Mona Wanda Schmidt Katrin Almstedt Anne-Sophie Heimes Walburgis Brenner Kathrin Stewen Marcus Schmidt Annette Hasenburg Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis Frontiers in Oncology vulvar cancer PD-L1 PD-1 pembrolizumab immune checkpoint inhibitor meta-analysis |
| title | Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis |
| title_full | Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis |
| title_fullStr | Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis |
| title_full_unstemmed | Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis |
| title_short | Efficacy of pembrolizumab in advanced cancer of the vulva: a systematic review and single-arm meta-analysis |
| title_sort | efficacy of pembrolizumab in advanced cancer of the vulva a systematic review and single arm meta analysis |
| topic | vulvar cancer PD-L1 PD-1 pembrolizumab immune checkpoint inhibitor meta-analysis |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2024.1352975/full |
| work_keys_str_mv | AT roxanaschwab efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT linajuditschiestl efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT lorenacascantortolano efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT philipherbertklecker efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT monawandaschmidt efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT katrinalmstedt efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT annesophieheimes efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT walburgisbrenner efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT kathrinstewen efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT marcusschmidt efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis AT annettehasenburg efficacyofpembrolizumabinadvancedcancerofthevulvaasystematicreviewandsinglearmmetaanalysis |