Gallego Alejandro, Madariaga Ainhoa, Estévez-García Purificación, Albertí Facundo, Carbó Anna, Palacio Isabel, Churruca Cristina, Gálvez Fernando, Ortega María Eugenia, Murata Paola, Manzano Aránzazu, Masvidal María, Martín-Lorente Cristina, Hernando Blanca, Lozano Inmaculada, Cueva Juan F, García-Illescas David, Gost Ester, Mendiola Marta, Redondo Andrés
Cancer Center Clínica Universidad de Navarra (CCUN), Department of Medical Oncology, Madrid, Spain; Cancer Center Clínica Universidad de Navarra (CCUN), Department of Medical Oncology, Pamplona, Spain.
Hospital Universitario 12 de Octubre, Department of Medical Oncology, Madrid, Spain.
Int J Gynecol Cancer. 2025 Jul;35(7):101903. doi: 10.1016/j.ijgc.2025.101903. Epub 2025 Apr 26.
Patients with advanced or recurrent endometrial cancer who experience progression following platinum-based chemotherapy have limited treatment options. The phase I GARNET trial showed the high efficacy of dostarlimab in treating mismatch repair deficient (dMMR) and/or microsatellite instability-high (MSI-H) endometrial cancer.
DORA is a multi-center, ambispective, observational real-world study evaluating the efficacy and safety of dostarlimab. The study included patients with dMMR/MSI-H endometrial cancer who had experienced tumor progression on or after a platinum-based treatment and had received at least 1 cycle of dostarlimab within the Spanish Expanded Access Program. The primary endpoints were objective response rate and duration of response.
A total of 129 patients from 57 of the Spanish Research Group for Gynaecological Cancer (GEICO) affiliated hospitals were enrolled, with 125 evaluable for radiological response. The median duration of dostarlimab administration was 8.8 months (interquartile range; 13.2), and 73 patients (57%) remained on therapy at the data cutoff. With a median follow-up of 11.6 months (range; 0.8-30.1), the objective response rate was 53.6% (95% CI 44.4 to 62.5). Complete response was observed in 27 patients (21.6%), and partial response in 40 (32%), with a median time to response of 2.9 months (95% CI 2.6 to 3.6). The median duration of response was not reached. The probability of maintaining the response at 12 and 24 months was 84.98% (95% CI 70.8 to 92.5) and 73.39% (95% CI 50.5 to 86.9), respectively. Treatment was discontinued due to toxicity in 4.7% of patients.
Dostarlimab monotherapy in dMMR/MSI-H endometrial cancer patients shows similar efficacy in real-world practice to that observed in the GARNET trial.
晚期或复发性子宫内膜癌患者在铂类化疗后出现病情进展，治疗选择有限。I期GARNET试验显示多斯塔利单抗在治疗错配修复缺陷（dMMR）和/或微卫星高度不稳定（MSI-H）子宫内膜癌方面具有高效性。
DORA是一项多中心、双向、观察性的真实世界研究，评估多斯塔利单抗的疗效和安全性。该研究纳入了dMMR/MSI-H子宫内膜癌患者，这些患者在铂类治疗期间或之后出现肿瘤进展，并在西班牙扩大使用计划内接受了至少1个周期的多斯塔利单抗治疗。主要终点是客观缓解率和缓解持续时间。
西班牙妇科癌症研究组（GEICO）下属57家医院共纳入129例患者，其中125例可评估放射学反应。多斯塔利单抗给药的中位持续时间为8.8个月（四分位间距；13.2），在数据截止时，73例患者（57%）仍在接受治疗。中位随访11.6个月（范围；0.8 - 30.1），客观缓解率为53.6%（95%CI 44.4至62.5）。27例患者（21.6%）观察到完全缓解，40例（32%）部分缓解，中位缓解时间为2.9个月（95%CI 2.6至3.6）。缓解持续时间未达到中位值。在12个月和24个月时维持缓解的概率分别为84.98%（95%CI 70.8至92.5）和73.39%（95%CI 50.5至86.9）。4.7%的患者因毒性反应而停药。
在真实世界实践中，多斯塔利单抗单药治疗dMMR/MSI-H子宫内膜癌患者的疗效与GARNET试验中观察到的相似。
