{"title":"Efficacy and safety of diffusing alpha-emitter radiation therapy (DaRT) for head and neck cancer recurrence after radiotherapy.","authors":"Ryo-Ichi Yoshimura, Kazuma Toda, Hiroshi Watanabe, Masahiko Miura, Ryoichi Notake, Naoya Murakami, Hiroshi Igaki, Satoshi Nakamura, Rei Umezawa, Noriyuki Kadoya, Keiichi Jingu, Jun Itami","doi":"10.1007/s10147-025-02720-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>To evaluate the efficacy and safety of diffusing alpha-emitter radiation therapy (DaRT) for recurrent head and neck cancer (rHNC) after radiotherapy.</p><p><strong>Methods: </strong>This study was a multicenter prospective clinical trial. Eligibility criteria included all patients with biopsy-proven rHNC and history of radiotherapy. The efficacy of DaRT was evaluated in terms of tumor shrinkage after 10 weeks of DaRT seed implantation. To assess safety of DaRT, radioactivity levels in blood and urine were measured, and incidence and grade of adverse events (AEs) were evaluated.</p><p><strong>Results: </strong>Between 2019 and 2021, DaRT was performed in 11 patients and completed in 10 patients with 11 tumors. The tumor sites included the tongue (n = 3), buccal mucosa (2), lips (2), floor of the mouth (1), soft palate (1), nose (1), and subcutaneous layer (1). Nine tumors were confirmed to be squamous cell carcinoma, and the remaining two tumors were basal cell carcinoma and neuroblastoma. Complete response (CR) and partial response (PR) were observed in three and six patients, respectively. The response rate was 81.8%. The maximum average radioactivity levels in blood and urine were 42.5 Bq/cm<sup>3</sup> and 8.4 Bq/cm<sup>3</sup>, respectively, on the second day after implantation. Forty AEs were observed in all 11 patients, including 22 Grade 1 AEs, 16 Grade 2, and 2 Grade 3 (hypertension and seed remnants).</p><p><strong>Conclusion: </strong>The initial response of rHNC after radiotherapy to DaRT was favorable, and the incidence and grade of AEs were acceptable, as compared to existing therapies.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":""},"PeriodicalIF":2.4000,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10147-025-02720-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: To evaluate the efficacy and safety of diffusing alpha-emitter radiation therapy (DaRT) for recurrent head and neck cancer (rHNC) after radiotherapy.
Methods: This study was a multicenter prospective clinical trial. Eligibility criteria included all patients with biopsy-proven rHNC and history of radiotherapy. The efficacy of DaRT was evaluated in terms of tumor shrinkage after 10 weeks of DaRT seed implantation. To assess safety of DaRT, radioactivity levels in blood and urine were measured, and incidence and grade of adverse events (AEs) were evaluated.
Results: Between 2019 and 2021, DaRT was performed in 11 patients and completed in 10 patients with 11 tumors. The tumor sites included the tongue (n = 3), buccal mucosa (2), lips (2), floor of the mouth (1), soft palate (1), nose (1), and subcutaneous layer (1). Nine tumors were confirmed to be squamous cell carcinoma, and the remaining two tumors were basal cell carcinoma and neuroblastoma. Complete response (CR) and partial response (PR) were observed in three and six patients, respectively. The response rate was 81.8%. The maximum average radioactivity levels in blood and urine were 42.5 Bq/cm3 and 8.4 Bq/cm3, respectively, on the second day after implantation. Forty AEs were observed in all 11 patients, including 22 Grade 1 AEs, 16 Grade 2, and 2 Grade 3 (hypertension and seed remnants).
Conclusion: The initial response of rHNC after radiotherapy to DaRT was favorable, and the incidence and grade of AEs were acceptable, as compared to existing therapies.
期刊介绍:
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.