An ambispective, real-world multi-center study of DOstarlimab in patients with Recurrent or Advanced DNA mismatch repair deficient/microsatellite instability-high endometrial cancer (GEICO 120-R/DORA study).

IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Alejandro Gallego, Ainhoa Madariaga, Purificación Estévez-García, Facundo Albertí, Anna Carbó, Isabel Palacio, Cristina Churruca, Fernando Gálvez, María Eugenia Ortega, Paola Murata, Aránzazu Manzano, María Masvidal, Cristina Martín-Lorente, Blanca Hernando, Inmaculada Lozano, Juan F Cueva, David García-Illescas, Ester Gost, Marta Mendiola, Andrés Redondo
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引用次数: 0

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: Dostarlimab monotherapy in dMMR/MSI-H endometrial cancer patients shows similar efficacy in real-world practice to that observed in the GARNET trial.

DOstarlimab治疗复发性或晚期DNA错配修复缺陷/微卫星不稳定性高的子宫内膜癌(GEICO 120-R/DORA研究)的双视角、现实世界多中心研究
目的:晚期或复发子宫内膜癌患者在铂类化疗后进展有限的治疗选择。I期GARNET试验显示,多司达单抗治疗错配修复缺陷(dMMR)和/或微卫星不稳定性高(MSI-H)子宫内膜癌的疗效很高。方法:DORA是一项多中心、双视角、观察性的真实世界研究,评估dostarlimumab的有效性和安全性。该研究纳入了dMMR/MSI-H子宫内膜癌患者,这些患者在接受铂类治疗时或治疗后出现肿瘤进展,并在西班牙扩展获取计划中接受了至少1个周期的dostarlimab。主要终点为客观缓解率和缓解持续时间。结果:来自57家西班牙妇科癌症研究小组(GEICO)附属医院的129名患者被纳入研究,其中125名可评估放射反应。dostarlimumab给药的中位持续时间为8.8个月(四分位数间距;13.2), 73名患者(57%)在数据截止时仍在接受治疗。中位随访11.6个月(范围;0.8 ~ 30.1),客观有效率为53.6% (95% CI为44.4 ~ 62.5)。27例患者(21.6%)完全缓解,40例患者(32%)部分缓解,中位缓解时间为2.9个月(95% CI 2.6 - 3.6)。中位反应持续时间未达到。12个月和24个月维持疗效的概率分别为84.98% (95% CI 70.8 ~ 92.5)和73.39% (95% CI 50.5 ~ 86.9)。4.7%的患者因毒性而停止治疗。结论:dostarlimumab单药治疗dMMR/MSI-H子宫内膜癌患者在实际实践中显示出与GARNET试验相似的疗效。
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来源期刊
CiteScore
6.60
自引率
10.40%
发文量
280
审稿时长
3-6 weeks
期刊介绍: The International Journal of Gynecological Cancer, the official journal of the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology, is the primary educational and informational publication for topics relevant to detection, prevention, diagnosis, and treatment of gynecologic malignancies. IJGC emphasizes a multidisciplinary approach, and includes original research, reviews, and video articles. The audience consists of gynecologists, medical oncologists, radiation oncologists, radiologists, pathologists, and research scientists with a special interest in gynecological oncology.
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