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局部晚期高级别胸腺瘤新辅助同步放化疗的II期临床试验。

A Phase II Clinical Trial of Neoadjuvant Concurrent Chemoradiotherapy for Locally Advanced High-Grade Thymic Tumors.

作者信息

Xu Ning, Wang Changlu, Zhang Qin, Hao Xiuxiu, Mao Teng, Shi Jianxin, Gu Zhitao, Gao Lanting, Shen Yan, Zhu Lei, Zhang Xuefei, Liu Yuan, Fang Wentao

机构信息

Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.

Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.

出版信息

JTO Clin Res Rep. 2025 Mar 5;6(6):100821. doi: 10.1016/j.jtocrr.2025.100821. eCollection 2025 Jun.

DOI:10.1016/j.jtocrr.2025.100821
PMID:40458540
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12127638/
Abstract

INTRODUCTION

Optimal management of locally advanced thymic tumors remains controversial. We conducted a clinical trial (ChiCTR-TNC-10001204) to investigate the safety and efficacy of neoadjuvant concurrent chemoradiotherapy in patients with locally advanced thymic tumors.

METHODS

The trial was conducted at the Shanghai Chest Hospital in patients with potentially unresectable high-grade thymic tumors. Induction consisted of chemotherapy (docetaxel and cisplatin) and concurrent radiation (40 Gy). The primary end point was objective response rate (ORR).

RESULTS

A total of 33 patients were accrued, including 11 with thymomas, 20 with thymic carcinomas, and two with neuroendocrine thymic tumors. ORR was 48.5%, with 16 patients having partial response. The other 17 had stable disease (SD). Thymomas had higher ORR (63.6%) than carcinomas (40.9%). A total of 13 patients (39.4%) experienced grades 3 to 4 toxicity. Surgical resection was feasible after induction in 23 patients (69.7%), among which 19 (82.6%) had complete resection. A higher rate of surgery (87.5% versus 52.9%,  = 0.057) and a significantly higher rate of R0 resection rate (81.3% versus 35.3%,  = 0.024) were observed in patients with partial response than in those with SD. Five-year overall survival and progression-free survival for the whole group were 63.5% and 44.9%, respectively. Patients with thymomas had significantly higher 5-year progression-free survival than the others (81.8% versus 25.6%,  = 0.012). Cumulative incidence of progression was significantly lower in patients with surgery than in those without (5-y CIP: 38.2% versus 80.0%,  = 0.045).

CONCLUSIONS

Neoadjuvant concurrent chemoradiotherapy is well tolerated and effective for patients with potentially unresectable high-grade thymic tumors, especially for patients with thymomas. Effective induction chemoradiation may help increase the chance of surgical resection and prolonged disease control. Future studies are in need to find more effective treatment approaches for patients with thymic carcinomas.

摘要

引言

局部晚期胸腺肿瘤的最佳治疗方案仍存在争议。我们开展了一项临床试验(ChiCTR-TNC-10001204),以研究新辅助同步放化疗对局部晚期胸腺肿瘤患者的安全性和疗效。

方法

该试验在上海胸科医院对潜在不可切除的高级别胸腺肿瘤患者进行。诱导治疗包括化疗(多西他赛和顺铂)及同步放疗(40 Gy)。主要终点为客观缓解率(ORR)。

结果

共纳入33例患者,其中胸腺瘤11例,胸腺癌20例,神经内分泌胸腺肿瘤2例。ORR为48.5%,16例患者部分缓解。另外17例疾病稳定(SD)。胸腺瘤的ORR(63.6%)高于胸腺癌(40.9%)。共有13例患者(39.4%)出现3至4级毒性反应。诱导治疗后23例患者(69.7%)可行手术切除,其中19例(82.6%)实现完全切除。部分缓解患者的手术率(87.5%对52.9%,P = 0.057)和R0切除率(81.3%对35.3%,P = 0.024)显著高于疾病稳定患者。全组患者的5年总生存率和无进展生存率分别为63.5%和44.9%。胸腺瘤患者的5年无进展生存率显著高于其他患者(81.8%对25.6%,P = 0.012)。手术患者的疾病进展累积发生率显著低于未手术患者(5年累积发生率:38.2%对80.0%,P = 0.045)。

结论

新辅助同步放化疗对潜在不可切除的高级别胸腺肿瘤患者耐受性良好且有效,尤其是对胸腺瘤患者。有效的诱导放化疗可能有助于增加手术切除机会并延长疾病控制时间。未来需要开展更多研究,为胸腺癌患者寻找更有效的治疗方法。

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