■子宫内膜癌是最广泛的妇科癌症,随着发病率和死亡率的增加。Pembrolizumab,一种靶向PD1受体肿瘤的单克隆抗体,已批准用于微卫星不稳定性高(MSI-H)实体瘤患者。已经进行了许多临床试验和观察性研究,以评估Lenvatinib和Pembrolizumab联合治疗子宫内膜癌的安全性和有效性。然而,结果不一致,目前的数据是基于异质群体。主要目的是评估Lenvatinib联合Pembrolizumab治疗子宫内膜癌的安全性和有效性。
■从一开始就从四个数据库进行搜索;PubMed,谷歌学者,Cochrane图书馆,和ClinicalTrials.gov.电子数据库搜索从开始到2023年8月20日进行。
■我们考虑了随机对照试验和单臂观察研究,即队列,病例对照和横断面研究。
■我们进行了单臂荟萃分析,涉及7项研究,最终纳入495例子宫内膜癌患者,其结果如下:完全缓解,部分响应,无进展生存,疾病稳定,进行性疾病,安全结果,不良事件,以及死亡总数。
■我们的结果显示,88.6%的患者为非MSI-H/pMMR肿瘤阳性(95%CI=0.825-0.927),而6.5%(95%CI=3.8-9.8%)的患者为MSI-H/dMMR肿瘤。使用Lenvatinib和Pembrolizumab治疗的子宫内膜癌患者的汇总客观反应为36.5%(95%CI=0.258-0.471),完全缓解和部分缓解的汇总估计值分别为47%(95%CI=0.024~0.070)和31.3%(95%CI=0.230~0.396).38.2%患者病情稳定(95%CI=0.329-0.435),24.0%患者病情进展(95%CI=0.103-0.378)。合并的中位无进展生存期为5.97(95%CI5.43-7.63)个月,而中位总生存期为17.19个月(95%CI15.34-19.31).在治疗期间,所有级别的不良事件发生率为85%,3级或更严重的不良事件发生率为39%,而在治疗期间死亡发生率为23.8%。
■这项荟萃分析的结果得出结论,尽管Lenvatinib和Pembrolizumab的联合治疗的PFS和OS低于用于治疗晚期和复发性子宫内膜癌的标准治疗,它仍然是一种新颖的治疗方法,并显示出具有更大样本量的进一步研究潜力。
UNASSIGNED: Endometrial carcinoma is the most widespread gynecological cancer, with increasing morbidity and mortality. Pembrolizumab, a monoclonal antibody that targets PD1 receptor tumors, is approved for patients with microsatellite instability-high (MSI-H) solid tumors. Many clinical trials and observational studies have been conducted to assess the safety and efficacy of Lenvatinib and Pembrolizumab combination therapy in the setting of endometrial cancer. However, results have been inconsistent, and current data is based on a heterogeneous population. The primary objective was to assess the safety and efficacy of Lenvatinib plus Pembrolizumab for endometrial cancer.
UNASSIGNED: The search was conducted from inception from four databases; PubMed, Google Scholar, the Cochrane Library, and ClinicalTrials.gov. The electronic database search was conducted from inception to August 20, 2023.
UNASSIGNED: We considered randomized controlled trials and single-arm observational studies, i.e. cohort, case-control and cross-sectional studies.
UNASSIGNED: We performed a single-arm meta-analysis, involving 7 studies having a total of 495 patients with endometrial cancer were eventually included which had the following outcomes: Complete response, Partial response, Progression-free survival, stable disease, progressive disease, safety outcomes, Adverse events, and the total number of deaths.
UNASSIGNED: Our results showed that 88.6 % of the patients were positive for non-MSI-H/pMMR tumors (95 % CI = 0.825-0.927) whereas 6.5 % (95 % CI = 3.8-9.8 %) of the patients for MSI-H/dMMR tumors. The pooled objective response of endometrial cancer patients treated with Lenvatinib and Pembrolizumab was 36.5 % (95 % CI = 0.258-0.471), the pooled estimate of complete and partial response was 47 % (95 % CI = 0.024-0.070) and 31.3 % (95 % CI = 0.230-0.396). 38.2 % patients had stable disease (95 % CI = 0.329-0.435) and 24.0 % patients had progressive disease (95 % CI = 0.103-0.378). The pooled median progression-free survival was 5.97 (95 % CI 5.43-7.63) months and, whereas the median overall survival was 17.19 months (95 % CI 15.34-19.31). All grade adverse events occurred in 85 % and Grade 3 or worse adverse events occurred in 39 % of patients during the therapy whereas death occurred in 23.8 % during the treatment.
UNASSIGNED: The results of this meta-analysis concludes that although the combined treatment of a Lenvatinib and Pembrolizumab had a PFS and OS that was inferior to the standard therapy used to treat advanced and recurrent endometrial cancer, it is still a novel treatment and shows potential for further research with a greater sample size.