■经尿道膀胱肿瘤电切术是膀胱癌分期>60年的主要治疗手段。分期不准确是司空见惯的,导致肌肉浸润性膀胱癌的延迟治疗。多参数磁共振成像提供了快速,肌肉浸润性膀胱癌的准确和非侵入性分期,有可能减少激进治疗的延误。
■评估在可疑肌层浸润性膀胱癌分期中,在经尿道膀胱肿瘤电切术之前引入多参数磁共振成像的可行性和有效性。
■开放标签,多阶段随机对照研究,分为三个部分:可行性,中间和最后的临床阶段。COVID大流行阻止了最后阶段的完成。
■英国15家医院。
■新诊断的年龄≥18岁的膀胱癌患者。
在门诊膀胱镜检查时对非肌层浸润性膀胱癌或肌层浸润性膀胱癌的怀疑进行视觉评估后,参与者被随机分配到路径1或路径2,根据5点Likert量表:Likert1-2个肿瘤被认为可能是非肌肉浸润性膀胱癌;Likert3-5个可能的肌肉浸润性膀胱癌。在途径1中,所有参与者都接受了经尿道膀胱肿瘤切除术。在途径2中,可能的非肌肉浸润性膀胱癌参与者接受了经尿道膀胱肿瘤切除术,可能的肌层浸润性膀胱癌参与者接受了初始多参数磁共振成像.后续治疗由治疗团队决定,可能包括经尿道膀胱肿瘤切除术。
■可行性阶段:与可能的肌肉浸润性膀胱癌的比例随机分配到路径2正确遵循协议。中间阶段:正确治疗肌层浸润性膀胱癌的时间。
■在2018年5月31日至2021年12月31日期间,共接诊638名患者,143名参与者被随机分配;52.1%被认为是可能的肌肉浸润性膀胱癌,47.9%可能是非肌肉浸润性膀胱癌。可行性阶段:36/39[92%(95%置信区间79至98%)]肌肉浸润性膀胱癌参与者遵循正确的治疗途径。中间阶段:路径1纠正治疗的中位时间为98天(95%置信区间72至125),路径2纠正治疗的中位时间为53天(95%置信区间20至89)[风险比2.9(95%置信区间1.0至8.1)],p=0.040。所有参与者正确治疗的中位时间为途径1为37天,途径2为25天[风险比1.4(95%置信区间0.9至2.0)]。
■对于接受化疗的参与者,多参数磁共振成像诊断为T2或更高阶段疾病的放射治疗或姑息治疗,由于没有组织病理学证实的肌肉浸润,因此无法最终确定这些治疗是否是正确的治疗方法,这在这些病例的放射学上得到证实。所有患者都有其癌症的组织学确认。由于COVID-19大流行,我们无法实现最后阶段。
■多参数磁共振成像导向途径导致肌肉浸润性膀胱癌正确治疗时间大幅减少45天,不损害非肌肉浸润性膀胱癌参与者。对于所有疑似肌肉浸润性膀胱癌的患者,应考虑在经尿道膀胱肿瘤电切术之前将多参数磁共振成像纳入标准途径。改进后的决策加快了治疗时间,尽管许多患者随后需要经尿道膀胱肿瘤切除术。部分患者可以完全避免经尿道膀胱肿瘤切除术,降低成本和发病率,与经尿道膀胱肿瘤电切术相比,磁共振成像和活检的成本要低得多。
■与最近开发的Vesical成像报告和数据系统交叉相关的进一步工作将提高准确性并有助于传播。还需要进行更长时间的随访,以检查该途径对结果的影响。掺入基于液体脱氧核糖核酸的生物标志物可以进一步提高决策质量,也应进一步研究。
■本研究注册为ISRCTN35296862。
■该奖项由美国国立卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:NIHR135775)资助,并在《卫生技术评估》中全文发布。28号42.有关更多奖项信息,请参阅NIHR资助和奖励网站。
BladderPath试验探索了如何加速诊断并避免不必要的手术治疗已经长成膀胱肌壁的膀胱癌患者,被称为肌肉浸润性膀胱癌。在最初的门诊诊断之后,目前,膀胱癌患者使用望远镜(经尿道膀胱肿瘤切除术)进行住院或日间手术切除肿瘤。该手术是治疗早期膀胱癌(非肌肉浸润性)的基础。然而,肌肉侵入性疾病,经尿道膀胱肿瘤切除术的主要作用是确认肿瘤已经生长到膀胱肌肉,这通常是不准确的;肌肉浸润性膀胱癌患者的实际正确治疗应该包括化疗,放疗和/或膀胱切除。对于这些患者来说,经尿道膀胱肿瘤切除术可能会延迟这种正确的治疗并影响生存。此外,对于因晚期疾病而确定需要姑息治疗的患者,经尿道膀胱肿瘤切除术可能代表过度治疗。使用造影剂的磁共振成像扫描(称为多参数磁共振成像)可以比正常扫描更清晰地显示膀胱,允许区分侵入性和非侵入性肿瘤。BladderPath试验研究了对疑似肌层浸润性膀胱癌患者增加多参数磁共振成像以及对治疗时间的影响。如果治疗团队在临床上确定有必要,则后续治疗可包括经尿道切除膀胱肿瘤。试验参与者被随机分配到标准途径(途径1:全部接受经尿道膀胱肿瘤切除术)或新的途径(途径2)。在途径2中,泌尿科医师进行最初的门诊膀胱诊断检查使用量表来评估肿瘤是否可能是非肌肉侵入性或可能是肌肉侵入性的。肿瘤可能出现肌肉侵入性的参与者进行了初步的多参数磁共振成像作为他们的下一步研究,而不是经尿道膀胱肿瘤切除术。然后,我们比较了从初始诊断到每个途径参与者接受正确治疗的持续时间。在143名参与者中,75(52.1%)被诊断为可能的肌肉侵入性。在途径1中,该组中一半的参与者接受肌肉浸润性膀胱癌正确治疗的持续时间为98天,在途径2中减少到53天。此外,两组中有一半参与者接受正确治疗的持续时间,途径1为37天,途径2为31天.总之,在疑似肌肉浸润性膀胱癌参与者中使用初始多参数磁共振成像大大减少了正确治疗的时间(手术,放射治疗,化疗或姑息治疗)并避免不必要的手术。对患有非侵入性疾病的参与者没有负面影响。对于疑似肌层浸润性膀胱癌的患者,建议在经尿道膀胱肿瘤电切术之前采用多参数磁共振成像。
UNASSIGNED: Transurethral resection of bladder tumour has been the mainstay of bladder cancer staging for > 60 years. Staging inaccuracies are commonplace, leading to delayed treatment of muscle-invasive bladder cancer. Multiparametric magnetic resonance imaging offers rapid, accurate and non-invasive staging of muscle-invasive bladder cancer, potentially reducing delays to radical treatment.
UNASSIGNED: To assess the feasibility and efficacy of the introducing multiparametric magnetic resonance imaging ahead of transurethral resection of bladder tumour in the staging of suspected muscle-invasive bladder cancer.
UNASSIGNED: Open-label, multistage randomised controlled study in three parts: feasibility, intermediate and final clinical stages. The COVID pandemic prevented completion of the final stage.
UNASSIGNED: Fifteen UK hospitals.
UNASSIGNED: Newly diagnosed bladder cancer patients of age ≥ 18 years.
UNASSIGNED: Participants were randomised to Pathway 1 or 2 following visual assessment of the suspicion of non-muscle-invasive bladder cancer or muscle-invasive bladder cancer at the time of outpatient cystoscopy, based upon a 5-point Likert scale: Likert 1-2 tumours considered probable non-muscle-invasive bladder cancer; Likert 3-5 possible muscle-invasive bladder cancer. In Pathway 1, all participants underwent transurethral resection of bladder tumour. In Pathway 2, probable non-muscle-invasive bladder cancer participants underwent transurethral resection of bladder tumour, and possible muscle-invasive bladder cancer participants underwent initial multiparametric magnetic resonance imaging. Subsequent therapy was determined by the treating team and could include transurethral resection of bladder tumour.
UNASSIGNED: Feasibility stage: proportion with possible muscle-invasive bladder cancer randomised to Pathway 2 which correctly followed the protocol. Intermediate stage: time to correct treatment for muscle-invasive bladder cancer.
UNASSIGNED: Between 31 May 2018 and 31 December 2021, of 638 patients approached, 143 participants were randomised; 52.1% were deemed as possible muscle-invasive bladder cancer and 47.9% probable non-muscle-invasive bladder cancer. Feasibility stage: 36/39 [92% (95% confidence interval 79 to 98%)] muscle-invasive bladder cancer participants followed the correct treatment by pathway. Intermediate stage: median time to correct treatment was 98 (95% confidence interval 72 to 125) days for Pathway 1 versus 53 (95% confidence interval 20 to 89) days for Pathway 2 [hazard ratio 2.9 (95% confidence interval 1.0 to 8.1)], p = 0.040. Median time to correct treatment for all participants was 37 days for Pathway 1 and 25 days for Pathway 2 [hazard ratio 1.4 (95% confidence interval 0.9 to 2.0)].
UNASSIGNED: For participants who underwent chemotherapy, radiotherapy or palliation for multiparametric magnetic resonance imaging-diagnosed stage T2 or higher disease, it was impossible to conclusively know whether these were correct treatments due to the absence of histopathologically confirmed muscle invasion, this being confirmed radiologically in these cases. All patients had histological confirmation of their cancers. Due to the COVID-19 pandemic, we were unable to realise the final stage.
UNASSIGNED: The multiparametric magnetic resonance imaging-directed pathway led to a substantial 45-day reduction in time to correct treatment for muscle-invasive bladder cancer, without detriment to non-muscle-invasive bladder cancer participants. Consideration should be given to the incorporation of multiparametric magnetic resonance imaging ahead of transurethral resection of bladder tumour into the standard pathway for all patients with suspected muscle-invasive bladder cancer. The improved decision-making accelerated time to treatment, even though many patients subsequently needed transurethral resection of bladder tumour. A proportion of patients can avoid transurethral resection of bladder tumour completely, reducing costs and morbidity, given the much lower cost of magnetic resonance imaging and biopsy compared to transurethral resection of bladder tumour.
UNASSIGNED: Further work to cross-correlate with the recently developed Vesical Imaging-Reporting and Data System will improve accuracy and aid dissemination. Longer follow-up to examine the effect of the pathway on outcomes is also required. Incorporation of liquid deoxyribonucleic acid-based biomarkers may further improve the quality of decision-making and should also be investigated further.
UNASSIGNED: This study is registered as ISRCTN 35296862.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR135775) and is published in full in Health Technology Assessment; Vol. 28, No. 42. See the NIHR Funding and Awards website for further award information.
The BladderPath trial explored how to accelerate diagnosis and avoid unnecessary surgery for patients with bladder cancer which had grown into the muscle wall of the bladder, referred to as muscle-invasive bladder cancer. Following initial outpatient diagnosis, bladder cancer patients currently undergo inpatient or day-case surgical tumour removal using a telescope (transurethral resection of bladder tumour). This surgery is fundamental to the treatment of early bladder cancer (non-muscle-invasive). However, for muscle-invasive disease, the main role of transurethral resection of bladder tumour is to confirm that the tumour has grown into the bladder muscle, and this is often inaccurate; the actual correct treatment for muscle-invasive bladder cancer patients should include chemotherapy, radiotherapy and/or bladder removal. For these patients, having transurethral resection of bladder tumour may delay this correct treatment and impact survival. Additionally, for patients determined to need palliative care due to advanced disease, the transurethral resection of bladder tumour may represent over-treatment. A magnetic resonance imaging scan with contrast agent (called multiparametric magnetic resonance imaging) gives a clearer picture of the bladder than normal scans, allowing distinction between invasive and non-invasive tumours. The BladderPath trial investigated adding multiparametric magnetic resonance imaging for patients with suspected muscle-invasive bladder cancer and the effect on treatment times. Subsequent therapy could include transurethral resection of bladder tumour if clinically determined as necessary by the treating team. Trial participants were randomly allocated either to the standard pathway (Pathway 1: all underwent transurethral resection of bladder tumour) or to a new pathway (Pathway 2). In Pathway 2, urologists conducting the initial outpatient diagnostic bladder inspections used a scale to assess whether tumours appeared to be either probably non-muscle-invasive or possibly muscle-invasive. Participants whose tumours appeared possibly muscle-invasive had initial multiparametric magnetic resonance imaging as their next investigation instead of transurethral resection of bladder tumour. We then compared the duration of time from initial diagnosis to receiving the correct treatment for participants in each pathway. Of the 143 participants, 75 (52.1%) were diagnosed as possibly muscle invasive. In Pathway 1, the duration for half of the participants in the group to have received their correct treatment for muscle-invasive bladder cancer was 98 days, which reduced to 53 days in Pathway 2. Furthermore, the duration for half of all the participants in the two groups to have received their correct treatment was 37 days for Pathway 1 and 31 days for Pathway 2. In summary, use of initial multiparametric magnetic resonance imaging in suspected muscle-invasive bladder cancer participants substantially reduced the time to correct treatment (surgery, radiotherapy, chemotherapy or instigation of palliative care) and avoided unnecessary surgery. There was no negative impact on participants with non-invasive disease. Adopting multiparametric magnetic resonance imaging into the pathway ahead of transurethral resection of bladder tumour for patients with suspected muscle-invasive bladder cancer is recommended.