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硼中子俘获疗法治疗头颈部癌症的初步结果:日本公共医疗保险体系覆盖治疗的真实世界经验(2 年期间)。

Preliminary outcomes of boron neutron capture therapy for head and neck cancers as a treatment covered by public health insurance system in Japan: Real-world experiences over a 2-year period.

机构信息

Department of Radiation Oncology, Osaka Medical and Pharmaceutical University, Osaka, Japan.

Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University, Osaka, Japan.

出版信息

Cancer Med. 2024 Jun;13(11):e7250. doi: 10.1002/cam4.7250.

Abstract

PURPOSE

Since June 2020, boron neutron capture therapy (BNCT) has been a health care service covered by health insurance in Japan to treat locally advanced or recurrent unresectable head and neck cancers. Therefore, we aimed to assess the clinical outcomes of BNCT as a health insurance treatment and explore its role among the standard treatment modalities for head and neck cancers.

MATERIALS AND METHODS

We retrospectively analyzed data from patients who were treated using BNCT at Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University, between June 2020 and May 2022. We assessed objective response rates based on the Response Evaluation Criteria in Solid Tumors version 1.1, and adverse events based on the Common Terminology Criteria for Adverse Events, version 5.0. Additionally, we conducted a survival analysis and explored the factors that contributed to the treatment results.

RESULTS

Sixty-nine patients (72 treatments) were included in the study, with a median observation period of 15 months. The objective response rate was 80.5%, and the 1-year locoregional control, progression-free survival, and overall survival rates were 57.1% (95% confidence interval [CI]: 43.9%-68.3%), 42.2% (95% CI: 30.1%-53.8%), and 75.4% (95% CI: 62.5%-84.5%), respectively. Locoregional control was significantly longer in patients with earlier TNM staging and no history of chemotherapy.

CONCLUSIONS

BNCT may be an effective treatment option for locally advanced or recurrent unresectable head and neck cancers with no other definitive therapies. If definitive surgery or radiation therapy are not feasible, BNCT should be considered at early disease stages.

摘要

目的

自 2020 年 6 月起,硼中子俘获疗法(BNCT)已被纳入日本医保,用于治疗局部晚期或复发性不可切除的头颈部癌症。因此,我们旨在评估 BNCT 作为医保治疗的临床疗效,并探讨其在头颈部癌症标准治疗方案中的作用。

材料与方法

我们回顾性分析了 2020 年 6 月至 2022 年 5 月期间在大阪医科药科大学关西 BNCT 医疗中心接受 BNCT 治疗的患者数据。我们根据实体瘤反应评价标准 1.1 评估客观缓解率,并根据不良事件通用术语标准 5.0 评估不良事件。此外,我们还进行了生存分析,并探讨了影响治疗结果的因素。

结果

本研究共纳入 69 例患者(72 次治疗),中位观察期为 15 个月。客观缓解率为 80.5%,1 年局部区域控制率、无进展生存率和总生存率分别为 57.1%(95%置信区间:43.9%-68.3%)、42.2%(95%置信区间:30.1%-53.8%)和 75.4%(95%置信区间:62.5%-84.5%)。局部区域控制在 TNM 分期较早且无化疗史的患者中更长。

结论

对于无其他确定性治疗方法的局部晚期或复发性不可切除的头颈部癌症,BNCT 可能是一种有效的治疗选择。如果无法进行确定性手术或放疗,应在疾病早期考虑 BNCT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d94c/11145025/f0df94a3ae36/CAM4-13-e7250-g005.jpg

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