同步放化療合併局部溫熱療法對局部侵襲性膀胱癌的治療潛力-第三期臨床試驗初步結果報告

王大齊¹、溫玉清^1,2*、賴宗豪¹、許軒豪¹、林克勳¹、林雍偉¹、蕭志豪¹、鍾卓興¹、游佩琪³、李良明¹

臺北市立萬芳醫院 泌尿科¹ 臺北醫學大學 醫學院 泌尿學科² 臺北市立萬芳醫院 護理部³

The Therapeutic Potential of Chemoradiotherapy Combine with Regional Hyperthermia Therapy for Locally Advanced Bladder Cancer- Phase III Clinical Trial Preliminary Data Report

Ta-Chyi Wang¹, Yu-Ching Wen ^1,2*, Syuan-Hao Syu¹, Benjamin Chung Howe Lai¹, Ke-Hsun Lin¹, Yung-Wei Lin¹, Chi-Hao Hsiao¹, Chung Cho Hsing¹, Pei Chi Yu³, Liang-Ming Lee¹

¹ Department of Urology, Wan Fang Hospital, Taipei Medical University

² Department of Urology, School of Medicine, College of Medicine, Taipei Medical University

³ Department of Nursing, Wan Fang Hospital, Taipei Medical University

Purpose: To evaluate the efficiency of chemotherapy concurrent radiotherapy (CCRT) combined with locoregional hyperthermia for locally advanced bladder urothelial carcinoma.

Materials and Methods: Between Aug 2019 and Mar 2022, 10 locally advanced bladder cancer patients were enrolled in this study. Patients were treated with CCRT combined with external deep pelvic hyperthermia (using a BSD-2000 device). Deep pelvic region including bladder was heated to 41^oC for 1 hour during CCRT treatment. The side effects, tumor response rate, progression-free survival, and overall survival were assessed.

Results: Ten patients were enrolled in this study. Median age was 65 years and 70% were male. The follow-up time was among 5-36 months. Complete remission (CR) in 6 patients, stable disease (SD) in one and progress disease (PD) in 3 patients. 6 patients with stage II bladder cancer were all CR. Two patients with stage III bladder cancer were SD in one and another were PD. Two patients with stage IV bladder cancer were all PD at follow-up time. One patient was dead due to disease progression. Adverse events were all minor (grade 2 or less) and all patients tolerated the whole treatment.

Conclusions: Chemotherapy concurrent radiotherapy (CCRT) combined with locoregional hyperthermia for locally advanced bladder cancer is a safe and effective treatment option. The prognosis of patients with stage II bladder cancer were CR until now.