Cho Sung Wook, Lim Sung Hee, Kwon Ghee Young, Kim Chan Kyo, Park Won, Pyo Hongryull, Chung Jae Hoon, Song Wan, Sung Hyun Hwan, Jeong Byong Chang, Park Se Hoon
Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Cancer Res Treat. 2024 Jul;56(3):893-897. doi: 10.4143/crt.2024.015. Epub 2024 Feb 15.
Bladder preservation chemoradiotherapy (CRT) in patients with a clinical complete response (cCR) following cisplatin-based neoadjuvant chemotherapy (NAC) is a promising treatment strategy for muscle-invasive bladder urothelial carcinoma (MIBC). A combined analysis of raw data from two prospective phase II studies was performed to better evaluate the feasibility of selective bladder preservation CRT.
The analysis was based on primary efficacy data from two independent studies, including 76 MIBC patients receiving NAC followed by bladder preservation CRT. The efficacy data included metastasis-free survival (MFS) and disease-free survival (DFS). For the present analysis, starting point of survival was defined as the date of commencing CRT.
Among 76 patients, 66 had a cCR following NAC. Sixty-four patients received gemcitabine and cisplatin (GC) combination chemotherapy in neoadjuvant setting, and 12 received nivolumab plus GC. Bladder preservation CRT following NAC was generally well-tolerated, with low urinary tract symptoms being the most common late complication. With a median follow-up of 64 months, recurrence was recorded in 43 patients (57%): intravesical only (n=20), metastatic only (n=16), and both (n=7). In 27 patients with intravesical recurrence, transurethral resection, and Bacillus Calmette-Guerin treatment was given to 17 patients. Salvage cystectomy was performed in 10 patients. Median DFS was 46.3 (95% confidence interval [CI], 25.1 to 67.5) months, and the median MFS was not reached. Neither DFS nor MFS appeared to be affected by any of the baseline characteristics. However, DFS was significantly longer in patients with a cCR than in those without (hazard ratio, 0.465; 95% CI, 0.222 to 0.976).
The strategy of NAC followed by selective bladder preservation CRT based on the cCR is feasible in the treatment of MIBC. A standardized definition of cCR is needed to better assess disease status post-NAC.
对于接受基于顺铂的新辅助化疗（NAC）后达到临床完全缓解（cCR）的肌肉浸润性膀胱尿路上皮癌（MIBC）患者，膀胱保留放化疗（CRT）是一种很有前景的治疗策略。对两项前瞻性II期研究的原始数据进行联合分析，以更好地评估选择性膀胱保留CRT的可行性。
该分析基于两项独立研究的主要疗效数据，包括76例接受NAC后行膀胱保留CRT的MIBC患者。疗效数据包括无转移生存期（MFS）和无病生存期（DFS）。在本次分析中，生存起点定义为开始CRT的日期。
76例患者中，66例在NAC后达到cCR。64例患者在新辅助治疗中接受了吉西他滨和顺铂（GC）联合化疗，12例接受了纳武单抗加GC。NAC后的膀胱保留CRT一般耐受性良好，下尿路症状是最常见的晚期并发症。中位随访64个月，43例患者（57%）出现复发：仅膀胱内复发（n = 20）、仅转移（n = 16）和两者皆有（n = 7）。在27例膀胱内复发患者中，17例接受了经尿道切除术和卡介苗治疗。10例患者接受了挽救性膀胱切除术。中位DFS为46.3（95%置信区间[CI]，25.1至67.5）个月，中位MFS未达到。DFS和MFS似乎均未受任何基线特征的影响。然而，cCR患者的DFS明显长于无cCR患者（风险比，0.465；95%CI，0.222至0.976）。
基于cCR的NAC后选择性膀胱保留CRT策略在MIBC治疗中是可行的。需要对cCR进行标准化定义，以更好地评估NAC后的疾病状态。
