卡姆雷珠单抗联合或不联合转移导向立体定向体放疗治疗复发性或转移性鼻咽癌的随机、多中心、II 期试验。

IF 6.4 1区医学 Q1 ONCOLOGY

International Journal of Radiation Oncology Biology Physics Pub Date : 2024-10-23 DOI:10.1016/j.ijrobp.2024.10.019

Xin Zhang, Jin Yan, Qianqian Lei, Jialing Neo, Sze Huey Tan, Xiaolei Shu, Luo Huang, Bin Long, Yue Xie, Feng Wang, Yuwei Wang, Honglei Tu, Chengchen Wang, Lu Zhang, Jieying Yang, Jianwen Zhang, Huawen Liu, Darren W T Lim, Melvin L K Chua, Jiang Dong Sui, Ying Wang

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Patients randomized to the MDT group must have 1 lesion that is amendable to stereotactic body radiation therapy (SBRT) prescribed to 27 Gy in 3 fractions every other day. The primary endpoint was objective response rate (ORR) of unirradiated lesions using Response Evaluation Criteria in Solid Tumors v1.1.Results: Between April 2021 and August 2023, 39 patients were randomly assigned to receive either Cam (n = 20) or Cam+MDT (n = 19). In total, 17 out of 39 (43.6%) patients had oligometastatic disease (≤3 lesions), 18 out of 39 (46.2%) had liver involvement, and 3 out of 39 (7.7%) had locoregional recurrent disease. ORR of unirradiated lesions did not differ between the treatment groups (26.3% [Cam+MDT] vs 30.0% [Cam], P = 1.0). The disease control rate of unirradiated lesions was 73.7% in the Cam+MDT group compared with 60.0% in the Cam group (P = .571). 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引用次数: 0

摘要

目的：研究转移导向疗法（MDT）与康瑞珠单抗（Cam）联合治疗复发性或转移性鼻咽癌（R/M-NPC）患者的疗效：我们在中国的3个中心开展了一项随机对照多中心II期试验（NCT04830267）。既往未接受过免疫疗法、病灶≥2个且至少有1个可测量病灶的R/M-NPC患者按1:1随机分配到Cam单药组或Cam加MDT（Cam+MDT）组。被随机分配到MDT组的患者必须有一个病灶可接受立体定向体放射治疗（SBRT），治疗剂量为27Gy，每隔一天分3次进行。主要终点是未照射病灶的客观反应率（ORR）（RECIST v1.1）：2021年4月至2023年8月期间，39名患者被随机分配接受Cam治疗（20人）或Cam+MDT治疗（19人）。17/39（43.6%）名患者患有寡转移性疾病（病灶≤3个）；18/39（46.2%）名患者肝脏受累；3/39（7.7%）名患者局部复发。治疗组之间未照射病灶的 ORR 无差异（26.3% [Cam+MDT] vs 30.0% [Cam]，P=1.0）。Cam+MDT组未照射病灶的DCR为73.7%，而Cam组为60.0%（P=0.571）。中位随访25.8个月后，Cam+MDT组的中位无进展生存期为9.3个月（95% CI：6.2-NR），Cam组为8.8个月（95% CI：3.3-NR）（P=0.750）。探索性分析显示，Cam+MDT 组病灶数大于 3 个的患者总生存期（OS）更长（HR 0.23 [95% CI：0.07-0.77]，P=0.009）。治疗组之间G3及以上不良事件发生率相当（15.8% [Cam+MDT] vs 20.0% [Cam]）。试验中毛细血管增生的总发生率为17.9%（7/39）：我们的研究没有达到其主要终点，即在Cam基础上加用MDT治疗R/M-NPC患者，未照射病灶的ORR更优。

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A Randomized, Multicenter, Phase 2 Trial of Camrelizumab With or Without Metastasis-directed Stereotactic Body Radiation Therapy in Recurrent or Metastatic Nasopharyngeal Carcinoma.

Purpose: To investigate the efficacy of metastasis-directed therapy (MDT) when added to camrelizumab (Cam) in patients with recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC).

Methods and materials: We conducted a randomized, controlled, multicenter, phase 2 trial in 3 centers from China (NCT04830267). Patients with R/M-NPC, without prior exposure to immunotherapy, who presented with ≥2 lesions, and at least 1 measurable lesion were randomized 1:1 to either Cam alone or Cam plus MDT (Cam+MDT). Patients randomized to the MDT group must have 1 lesion that is amendable to stereotactic body radiation therapy (SBRT) prescribed to 27 Gy in 3 fractions every other day. The primary endpoint was objective response rate (ORR) of unirradiated lesions using Response Evaluation Criteria in Solid Tumors v1.1.

Results: Between April 2021 and August 2023, 39 patients were randomly assigned to receive either Cam (n = 20) or Cam+MDT (n = 19). In total, 17 out of 39 (43.6%) patients had oligometastatic disease (≤3 lesions), 18 out of 39 (46.2%) had liver involvement, and 3 out of 39 (7.7%) had locoregional recurrent disease. ORR of unirradiated lesions did not differ between the treatment groups (26.3% [Cam+MDT] vs 30.0% [Cam], P = 1.0). The disease control rate of unirradiated lesions was 73.7% in the Cam+MDT group compared with 60.0% in the Cam group (P = .571). After a median follow-up of 25.8 months, median progression-free survival was 9.3 (95% CI, 6.2-not reached [NR]) months in the Cam+MDT group and 8.8 (95% CI, 3.3-NR) months in the Cam group (P = .750). Exploratory analyses suggested a longer overall survival (OS) with Cam+MDT for patients with >3 lesions (HR, 0.23; 95% CI, 0.07-0.77; P = .009). G3 and above adverse events were comparable between the treatment groups (15.8% [Cam+MDT] vs 20.0% [Cam]). The overall rate of capillary proliferation was 17.9% (7/39) for the trial.

Conclusions: Our study did not meet its primary endpoint of superior ORR of unirradiated lesions with the addition of MDT to Cam in patients with R/M-NPC.

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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.