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卡瑞利珠单抗联合或不联合转移灶定向立体定向体部放射治疗复发性或转移性鼻咽癌的随机、多中心、2期试验

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

作者信息

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

机构信息

Radiation Oncology Centre, Chongqing University Cancer Hospital, Chongqing, China.

Division of Medical Sciences, National Cancer Centre Singapore, Singapore.

出版信息

Int J Radiat Oncol Biol Phys. 2025 Mar 15;121(4):980-990. doi: 10.1016/j.ijrobp.2024.10.019. Epub 2024 Oct 23.

DOI:10.1016/j.ijrobp.2024.10.019

PMID:39454735

Abstract

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.

摘要

目的

探讨在复发或转移性鼻咽癌（R/M-NPC）患者中，将转移灶导向治疗（MDT）与卡瑞利珠单抗（Cam）联合使用的疗效。

方法和材料

我们在中国的3个中心进行了一项随机、对照、多中心的2期试验（NCT04830267）。既往未接受过免疫治疗、有≥2个病灶且至少有1个可测量病灶的R/M-NPC患者按1:1随机分为单纯Cam组或Cam联合MDT组（Cam+MDT）。随机分配到MDT组的患者必须有1个适合立体定向体部放疗（SBRT）的病灶，处方剂量为27 Gy，分3次，隔日照射。主要终点是使用实体瘤疗效评价标准v1.1评估未照射病灶的客观缓解率（ORR）。

结果

2021年4月至2023年8月期间，39例患者被随机分配接受Cam（n = 20）或Cam+MDT（n = 19）治疗。39例患者中共有17例（43.6%）为寡转移疾病（≤3个病灶），18例（46.2%）有肝脏受累，3例（7.7%）有局部区域复发疾病。治疗组间未照射病灶的ORR无差异（26.3% [Cam+MDT] vs 30.0% [Cam]，P = 1.0）。Cam+MDT组未照射病灶的疾病控制率为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（95% CI，6.2-未达到[NR]）个月，Cam组为8.8（�5% CI，3.3-NR）个月（P = 0.750）。探索性分析表明，对于病灶>3个的患者，Cam+MDT组的总生存期（OS）更长（HR，0.23；95% CI，0.07-0.77；P = 0.009）。治疗组间3级及以上不良事件相当（15.8% [Cam+MDT] vs 20.0% [Cam]）。试验中毛细血管增生的总体发生率为17.9%（7/39）。