Shamseddine Ali, Abbas Noura, Temraz Sally, Al Darazi Monita, Charafeddine Maya, Dagher Kristel, Youssef Bassem, Nasr Rami, Khauli Raja, El Hajj Albert, Bulbul Muhammad
Department of Internal Medicine, Division of Hematology/Oncology, Naef K. Basile Cancer Institute, American University of Beirut Medical Center, Beirut, Lebanon.
Department of Radiation Oncology, American University of Beirut Medical Center, Beirut, Lebanon.
Future Oncol. 2025 Aug 25:1-12. doi: 10.1080/14796694.2025.2549244.
BACKGROUND/AIMS: Muscle-invasive bladder cancer (MIBC) has a 5-year survival rate of 40-60% following traditional treatment with neoadjuvant chemotherapy (NAC) and radical cystectomy (RC), which significantly impacts quality of life. Bladder preservation strategies, including maximal transurethral resection of the bladder tumor (TURBT), NAC, and radiation therapy, offer similar survival rates with better quality of life. Immune checkpoint inhibitors like avelumab show potential benefits when combined with bladder preservation modalities. This phase II randomized, non-comparative, double-arm, open-label, multicenter trial evaluates the efficacy and safety of two tetra-modality bladder preservation strategies in MIBC patients (T2-T4N0M0). The primary endpoint is the 2-year proportion of bladder-preserved participants. Secondary endpoints include response rates post-induction, quality of life, and safety evaluations.
Eighty participants will be randomized 1:1 into Arm A or Arm B. All participants will first receive induction chemotherapy (DDMVAC or GC) combined with avelumab, followed by disease evaluation using imaging and TURBT. Those achieving a complete or near-complete response will proceed to hypofractionated radiation therapy (55 Grays in 20 fractions). After radiation, Arm A will receive maintenance avelumab for 1 year, while Arm B will follow a watch-and-wait approach. Non-responders in both arms will be referred for salvage RC.
NCT06686381 (ClinicalTrials.gov).
背景/目的：肌肉浸润性膀胱癌（MIBC）采用新辅助化疗（NAC）和根治性膀胱切除术（RC）的传统治疗后，5年生存率为40%-60%，这对生活质量有显著影响。膀胱保留策略，包括最大程度经尿道膀胱肿瘤切除术（TURBT）、NAC和放射治疗，生存率相似且生活质量更佳。免疫检查点抑制剂如阿维鲁单抗与膀胱保留方式联合使用时显示出潜在益处。这项II期随机、非对照、双臂、开放标签、多中心试验评估了两种四联膀胱保留策略对MIBC患者（T2-T4N0M0）的疗效和安全性。主要终点是保留膀胱的参与者的2年比例。次要终点包括诱导后缓解率、生活质量和安全性评估。
80名参与者将按1:1随机分为A组或B组。所有参与者首先接受诱导化疗（DDMVAC或GC）联合阿维鲁单抗，随后使用影像学和TURBT进行疾病评估。达到完全或接近完全缓解的患者将接受大分割放射治疗（20次分割，共55格雷）。放疗后，A组将接受1年的阿维鲁单抗维持治疗，而B组将采用观察等待方法。两组无反应者将被转诊进行挽救性RC。
NCT06686381（ClinicalTrials.gov）。
Zotero 插件