Schwab Roxana, Schiestl Lina Judit, Cascant Ortolano Lorena, Klecker Philip Herbert, Schmidt Mona Wanda, Almstedt Katrin, Heimes Anne-Sophie, Brenner Walburgis, Stewen Kathrin, Schmidt Marcus, Hasenburg Annette
Department of Obstetrics and Gynecology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.
Departmental Library, University Medical Center Mainz, Johannes Gutenberg University Mainz, Mainz, Germany.
Front Oncol. 2024 Feb 19;14:1352975. doi: 10.3389/fonc.2024.1352975. eCollection 2024.
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.
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 and the Cochrane Q χ2 statistics.
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.
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.
https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888.
外阴癌早期预后良好。然而，尽管有多种治疗方式，如广泛手术切除、化疗和放疗，但晚期或复发病例的治疗选择仍然有限。最重要的新兴治疗方式是免疫检查点抑制剂。本系统评价和荟萃分析旨在评估免疫检查点抑制剂帕博利珠单抗治疗晚期外阴癌女性患者的疗效和安全性。
在进行全面检索、综述和评估后，纳入了两项相关的单臂研究。使用R4.3.0软件和RStudio 2023.03.0进行荟萃分析，以95%置信区间呈现总体效应量。使用I²和Cochrane Q χ²统计量评估异质性。
在筛选出的154项符合条件的研究中，纳入了两项单臂研究，共119例接受帕博利珠单抗治疗的晚期外阴癌患者。汇总的客观缓解率（ORR）总体为10%（95%CI：0.00 - 0.84），在PD-L1阳性亚组中为9%（95%CI：0.00 - 0.89）。在意向性分析（ITT）人群中，31%（95%CI：0.04 - 0.85）表现出任何临床获益（完全缓解、部分缓解或疾病稳定）。在ITT人群中，6个月时无进展生存期（PFS）为19%（95%CI：0.01 - 0.82），总生存期（OS）为48%（95%CI：0.08 - 0.90）。12个月时，PFS降至9%（95%CI：0.00 - 0.85），OS为33%（95%CI：0.04 - 0.85）。在PFS和OS分析中未观察到统计学上显著的异质性。
本研究表明，三分之一的晚期或复发性外阴癌女性患者可能不受PD-L1状态影响，从帕博利珠单抗治疗中获益，尽管12个月时PFS和OS均有所下降。这些发现为在这一特定癌症患者亚组的治疗模式中考虑使用帕博利珠单抗提供了支持。
