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胸膜播散或复发的胸腺上皮肿瘤的减瘤手术及胸腔内热化疗:一项前瞻性、单臂、II期研究。

Cytoreductive surgery and hyperthermic intrathoracic chemotherapy in thymic epithelial tumors with pleural spread or recurrence: a prospective, single-arm, phase II study.

作者信息

Wang Shuai, Yang Xinyu, Jiang Jiahao, Liang Fei, Zheng Yuansheng, Ao Yongqiang, Gao Jian, Wang Hao, Tan Lijie, Ding Jianyong

机构信息

Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.

Cancer Center, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.

出版信息

Nat Commun. 2025 Jun 4;16(1):5175. doi: 10.1038/s41467-025-60386-0.

DOI:10.1038/s41467-025-60386-0
PMID:40467556
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12137697/
Abstract

Pleural spread or recurrence of thymic epithelial tumors (TETs) is a tricky puzzle in the clinic and there is currently no recognized effective treatment. This trial evaluated the safety and efficacy of cytoreductive surgery and hyperthermic intrathoracic chemotherapy (S-HITOC) for TETs with pleural spread or recurrence. Here, we reported short-term outcomes of enrolled 45 patients receiving S-HITOC with 25 mg/m doxorubicin and 50 mg/m cisplatin. The pleural tumor index (PTI) has been proposed for evaluating pleural tumor burden. Treatment-related adverse events of grade ≥3 occurred in eight (17.8%) patients. The pain Visual analog scale (VAS) score was 5.4 ± 1.9 on the 1st day after treatment and was similar to that at baseline level on the 7th day after treatment (p = 0.218). There was no significant difference in the quality of life score (p = 0.676) between baseline and the 60th day after treatment. The estimated 2-year PFS and OS rates were 82.8% and 100.0%, respectively. Subgroup analyses revealed that patients with PTI scores >10 had worse PFS than those with PTI scores ≤10 (p < 0.001). S-HITOC had a manageable complication rate. Early clinical outcomes confirmed that S-HITOC offers encouraging oncological benefits for TETs and satisfactory control of myasthenia gravis. Trial number: NCT05446935.

摘要

胸腺上皮肿瘤(TETs)的胸膜播散或复发在临床上是一个棘手的难题,目前尚无公认的有效治疗方法。本试验评估了减瘤手术和胸腔内热化疗(S-HITOC)治疗胸膜播散或复发的TETs的安全性和有效性。在此,我们报告了45例接受含25mg/m多柔比星和50mg/m顺铂的S-HITOC治疗患者的短期结果。已提出胸膜肿瘤指数(PTI)用于评估胸膜肿瘤负荷。8例(17.8%)患者发生≥3级治疗相关不良事件。治疗后第1天疼痛视觉模拟量表(VAS)评分为5.4±1.9,与治疗后第7天的基线水平相似(p=0.218)。治疗后第60天与基线时的生活质量评分无显著差异(p=0.676)。估计2年无进展生存期(PFS)和总生存期(OS)率分别为82.8%和100.0%。亚组分析显示,PTI评分>10的患者的PFS比PTI评分≤10的患者差(p<0.001)。S-HITOC的并发症发生率可控。早期临床结果证实,S-HITOC为TETs带来了令人鼓舞的肿瘤学益处,并能令人满意地控制重症肌无力。试验编号:NCT05446935。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/6d37d260e990/41467_2025_60386_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/3f244d4d0fff/41467_2025_60386_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/cddcef97c810/41467_2025_60386_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/6d37d260e990/41467_2025_60386_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/3f244d4d0fff/41467_2025_60386_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/cddcef97c810/41467_2025_60386_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab41/12137697/6d37d260e990/41467_2025_60386_Fig3_HTML.jpg

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本文引用的文献

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J Thorac Dis. 2024 Jan 30;16(1):760-767. doi: 10.21037/jtd-23-759. Epub 2023 Dec 25.
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The International Association for the Study of Lung Cancer Thymic Epithelial Tumors Staging Project: Proposals for the N and the M Components for the Forthcoming (Ninth) Edition of the TNM Classification of Malignant Tumors.国际肺癌研究协会胸腺上皮肿瘤分期项目:即将发布的(第九版)《恶性肿瘤 TNM 分类》中 N 和 M 成分的建议。
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Subtotal Pleurectomy with Intrathoracic Chemo Hyperthermia (HITHOC) for IVa Thymomas: De Novo Versus Recurrent Pleural Disease.胸腺瘤IVa期行胸膜部分切除术联合胸腔内热化疗(HITHOC):初发性与复发性胸膜疾病
Cancers (Basel). 2022 Oct 14;14(20):5035. doi: 10.3390/cancers14205035.
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