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度伐利尤单抗联合放疗用于不可切除的 III 期 NSCLC 患者,这些患者由于不适合化疗而无法接受化疗。

DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy.

机构信息

Department of Radiation Oncology, Fondazione IRCCS Policlinico San Matteo & University of Pavia, Pavia 27100, Italy.

Department of Oncology & Radiotherapy, Medical University of Gdansk, Gdansk 80-210, Poland.

出版信息

Future Oncol. 2021 Dec;17(34):4657-4663. doi: 10.2217/fon-2021-0952. Epub 2021 Nov 15.

Abstract

Consolidation durvalumab is standard of care in patients with unresectable, stage III non-small-cell lung cancer (NSCLC) without disease progression following chemoradiotherapy (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. These patients typically receive radiotherapy alone, with poor survival outcomes. Based on the PACIFIC trial data, and the strong biological rationale for combining radiotherapy with anti-programmed cell death ligand-1 therapy, durvalumab following radiotherapy could provide additional survival benefit versus radiotherapy alone. Here, we describe the DUART trial, a Phase II, open-label, single-arm study assessing the safety and tolerability of durvalumab following radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy (ClinicalTrials.gov Identifier: NCT04249362).

摘要

巩固性 durvalumab 是不可切除的 III 期非小细胞肺癌(NSCLC)患者的标准治疗方法,这些患者在放化疗后没有疾病进展(“PACIFIC 方案”)。然而,由于预期毒性较高,许多身体状况较差、年龄较大或合并症较多的患者不符合化疗条件。这些患者通常单独接受放疗,生存结局较差。基于 PACIFIC 试验数据,以及将放疗与抗程序性细胞死亡配体-1 治疗联合应用的强有力的生物学原理,放疗后使用 durvalumab 可能会比单独放疗提供额外的生存获益。在这里,我们描述了 DUART 试验,这是一项 II 期、开放标签、单臂研究,评估了 durvalumab 在不适合化疗的不可切除的 III 期 NSCLC 患者中的安全性和耐受性(ClinicalTrials.gov 标识符:NCT04249362)。

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