Durvalumab combined with chemotherapy and Stereotactic Ablative Body Radiotherapy (SABR) in patients with oligometastatic non-small cell lung cancer: a multi-center phase 2 study.

IF 6.5 1区医学 Q1 ONCOLOGY

International Journal of Radiation Oncology Biology Physics Pub Date : 2025-09-24 DOI:10.1016/j.ijrobp.2025.09.045

Qiwen Li, Honglian Ma, Rongliang Zheng, Ling Cai, Yuan Zhang, Yihong Ling, Fang Peng, Anwen Liu, Hualin Chen, Yong Bao, Yujin Xu, Ming Chen

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引用次数: 0

Abstract

Purpose: Immunotherapy plus chemotherapy is the standard of care for driver-gene negative metastatic non-small cell lung cancer (NSCLC). Synchronous oligometastatic disease has a better prognosis than extensive metastasis, and the addition of Stereotactic Ablative Radiotherapy (SABR) results in improved efficacy. However, whether the combination of SABR with immunotherapy and platinum-doublet chemotherapy will lead to long-term disease control or even cure for patients remains unclear.

Patients and methods: This was a multi-center, phase 2, single-arm study to evaluate the efficacy and safety of durvalumab in combination with chemotherapy and SABR for oligometastatic stage IV NSCLC without previous systemic therapy. The primary endpoint was investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1.

Results: Thirty-five patients were enrolled in the study. Twenty-eight (80%) patients received radiotherapy (RT), including 23 (65.7%) received SABR. The median follow-up time was 24.7 months (95% CI, 21.6-27.5). In the full analysis set (n=35), the median PFS (mPFS) was 10.4 months (95% CI, 4.4-26.1), and the two-year PFS rate and overall survival (OS) rate were 38.5% (95% CI, 21.9-54.8%) and 67.7% (95% CI, 49.0-80.7%), respectively. In the per protocol set (n=32), mPFS was 14.6 months (95% CI, 4.7-26.1), and the two-year PFS rate and OS rate were 42.4% (95% CI, 24.3-59.4%) and 70.8% (95% CI, 51.2-83.8%), respectively. The subgroup analysis showed that the mPFS was 24.3 months (95%CI, 7.6-NE) with SABR vs 3.1 months (95% CI, 1.4-4.7) without SABR (HR, 0.2; 95% CI, 0.09-0.5; P<0.001). Grade 3 or higher treatment related adverse events (TRAEs) and immune-mediated AEs (imAEs) were reported in 57.1% (20/35) and 25.7% (9/35) of patients, respectively.

Conclusions: In oligometastatic NSCLC, the combination of durvalumab, chemotherapy and SABR was effective and tolerable. Patients who did not experience disease progression after prior systemic therapy and received SABR might have optimal outcomes.

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Durvalumab联合化疗和立体定向消融体放疗（SABR）治疗低转移性非小细胞肺癌：一项多中心2期研究

目的：免疫治疗加化疗是驱动基因阴性转移性非小细胞肺癌（NSCLC）的标准治疗方案。同步少转移性疾病的预后优于广泛转移性疾病，而立体定向消融放疗（SABR）的加入可提高疗效。然而，SABR联合免疫治疗和铂双药化疗是否能使患者长期控制疾病甚至治愈尚不清楚。患者和方法：这是一项多中心、2期、单臂研究，旨在评估durvalumab联合化疗和SABR治疗未接受过全身治疗的寡转移性IV期NSCLC的疗效和安全性。主要终点是根据实体瘤1.1版反应评估标准，研究者评估的无进展生存期（PFS）。结果：35例患者入组研究。放疗28例（80%），其中SABR 23例（65.7%）。中位随访时间为24.7个月（95% CI, 21.6-27.5）。在整个分析集中（n=35），中位PFS （mPFS）为10.4个月（95% CI, 4.4-26.1），两年PFS率和总生存率（OS）分别为38.5% （95% CI, 21.9-54.8%）和67.7% （95% CI, 49.0-80.7%）。在每个方案集（n=32）中，mPFS为14.6个月（95% CI, 4.7-26.1），两年PFS率和OS率分别为42.4% （95% CI, 24.3-59.4%）和70.8% （95% CI, 51.2-83.8%）。亚组分析显示，有SABR的mPFS为24.3个月（95%CI, 7.6 ne），而没有SABR的mPFS为3.1个月（95%CI, 1.4-4.7）（HR, 0.2; 95%CI, 0.09-0.5）。结论：在低转移性NSCLC中，durvalumab、化疗和SABR联合治疗是有效且耐受的。在先前的全身治疗后没有经历疾病进展并接受SABR的患者可能有最佳的结果。

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来源期刊

International Journal of Radiation Oncology Biology Physics 医学-核医学

CiteScore

11.00

自引率

7.10%

发文量

2538

审稿时长

6.6 weeks

期刊介绍： International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.