Bristol Myers Squibb, Lawrence Township, NJ, USA.
Adelphi Real World, Bollington, UK.
BMC Urol. 2022 Feb 26;22(1):27. doi: 10.1186/s12894-022-00959-z.
Intravesical bacillus Calmette-Guérin (BCG) fails in a considerable proportion of non-muscle invasive bladder cancer (NMIBC) patients despite treatment per recommended protocol. This real-world study aimed to understand the current patterns of treatment and disease management for the broad BCG-unresponsive NMIBC patient population, alongside collecting sufficient data on patients who do not undergo cystectomy.
This was a multicenter, retrospective survey of physicians treating BCG-unresponsive NMIBC patients. Data were collected in eight countries - France, Germany, Spain, Italy, United Kingdom, United States, China, and Japan - between January and May 2019. The study consisted of a short online physician survey and a retrospective chart review of eligible BCG-unresponsive NMIBC patients. Physicians abstracted chart data for the last 10 (five patients in Japan) eligible BCG-unresponsive NMIBC patients meeting the inclusion criteria, and the data were analysed for all countries combined using descriptive statistics. Country-specific analyses were also carried out, as appropriate.
Overall, 508 physicians participated in the study. Almost one-quarter (22.9%) of physicians' current NMIBC patient caseload was BCG-unresponsive, whereby BCG therapy was no longer considered an option. Half of physicians (49.4%) did not regularly use biomarker tests in their practice, with particularly few physicians undertaking biomarker testing in Spain and Japan. Biomarker testing varied considerably, with the proportions of physicians selecting 'none' ranging from 11.4% in China to 70.3% in Japan. Physicians reported transurethral resection of the bladder tumor (TURBT) and BCG as the most common current treatments received by their patients. Chemotherapy and anti-PD-L1 treatment options were considered impactful new therapies by 94.7% and 90.0% of physicians surveyed in this study, respectively.
The most common treatments received by patients in this study were TURBT and BCG. Emerging new treatments are driven by exploring biomarkers, but in real-world clinical practice only half of physicians or fewer regularly tested their NMIBC patients for biomarkers; PD-1/PD-L1 was the most common biomarker test used. Most physicians reported that, in addition to chemotherapy, anti-PD-L1 was an impactful new therapy.
尽管按照推荐方案进行了治疗,卡介苗(BCG)在相当一部分非肌肉浸润性膀胱癌(NMIBC)患者中仍然失败。本项真实世界研究旨在了解广泛的对卡介苗无反应的 NMIBC 患者人群的当前治疗和疾病管理模式,同时收集未接受膀胱切除术的患者的足够数据。
这是一项多中心、回顾性调查研究,涉及治疗对卡介苗无反应的 NMIBC 患者的医生。数据于 2019 年 1 月至 5 月在八个国家(法国、德国、西班牙、意大利、英国、美国、中国和日本)收集。该研究由简短的在线医生调查和对符合纳入标准的对卡介苗无反应的 NMIBC 患者的回顾性图表审查组成。医生为符合纳入标准的最后 10 名(日本 5 名)对卡介苗无反应的 NMIBC 患者的合格病历数据进行了摘录,并使用描述性统计对所有国家的数据进行了分析。还酌情进行了国家特定分析。
总体而言,共有 508 名医生参与了该研究。近四分之一(22.9%)的医生当前的 NMIBC 患者中卡介苗无反应,因此不再考虑卡介苗治疗。一半的医生(49.4%)在实践中没有定期使用生物标志物检测,西班牙和日本的医生尤其很少进行生物标志物检测。生物标志物检测差异很大,选择“无”的医生比例在中国为 11.4%,在日本为 70.3%。医生报告说,经尿道膀胱肿瘤切除术(TURBT)和卡介苗是他们的患者最常接受的当前治疗方法。化疗和抗 PD-L1 治疗选择被调查的医生分别认为是 94.7%和 90.0%的有影响力的新疗法。
本研究中患者最常接受的治疗方法是 TURBT 和卡介苗。新兴的新疗法是通过探索生物标志物驱动的,但在真实世界的临床实践中,只有一半或更少的医生定期为他们的 NMIBC 患者检测生物标志物;PD-1/PD-L1 是最常用的生物标志物检测。大多数医生报告说,除了化疗外,抗 PD-L1 也是一种有影响力的新疗法。