Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, Milan, Italy.
(DIPO), University of MilanDepartment of Oncology and Hemato-Oncology, Milan, Italy.
Expert Opin Biol Ther. 2022 Jun;22(6):717-734. doi: 10.1080/14712598.2022.2082869. Epub 2022 May 31.
Non-muscle invasive bladder cancer (NMIBC) accounts for 70-75% of all bladder cancers and is a heterogeneous disease characterized by a wide spectrum of recurrences and progression. Adjuvant treatment for intermediate- and high-risk NMIBC is mainly represented by Bacillus Calmette Guerin (BCG). However, 20%-40% of patients develop disease recurrences or persistence following BCG treatment and are classified as "BCG unresponsive' (BCGu), thus representing a therapeutic challenge due to their worse prognosis and unavailability of effective intravesical treatments.
We provide an overview of completed and ongoing clinical trials assessing the role of innovative immunological and target agents in patients with BCGu and BCG naive (BCGn) NMIBCs. New treatment options are emerging, demonstrating promising clinical activity, namely, pembrolizumab, atezolizumab, oportuzumab monatox, nadofaragene firadenovec, and N-803.
The increasing number of newer therapeutic agents for patients with NMIBC poses challenges regarding the choice of the most suited treatment option for each patient and the best treatment sequence, given their diverse mechanisms of action and varying degrees of activity. Tailored treatment approaches are advocated, based on a deeper comprehension of disease features, available therapies, patient's characteristics, and consequently, on the identification and validation of prognostic and predictive biomarkers.
非肌肉浸润性膀胱癌(NMIBC)占所有膀胱癌的 70-75%,是一种异质性疾病,具有广泛的复发和进展谱。中高危 NMIBC 的辅助治疗主要以卡介苗(BCG)为代表。然而,20%-40%的患者在 BCG 治疗后出现疾病复发或持续存在,并被归类为“BCG 无应答”(BCGu),因此由于其预后较差且缺乏有效的膀胱内治疗,成为治疗挑战。
我们提供了已完成和正在进行的临床试验的概述,这些试验评估了创新的免疫和靶向药物在 BCGu 和 BCG 初治(BCGn)NMIBC 患者中的作用。新的治疗选择正在出现,显示出有希望的临床活性,即 pembrolizumab、atezolizumab、oportuzumab monatox、nadofaragene firadenovec 和 N-803。
对于 NMIBC 患者,越来越多的新型治疗药物带来了挑战,需要根据每位患者的具体情况选择最合适的治疗方案,以及最佳的治疗顺序,因为它们具有不同的作用机制和不同程度的活性。提倡基于对疾病特征、可用疗法、患者特征的更深入理解,采取个体化治疗方法,并确定和验证预后和预测生物标志物。