Could We Safely Avoid a Second Resection in Selected Patients With T1 Non-Muscle-Invasive Bladder Cancer? Preliminary Results of Cost-Effectiveness Study From HUmanitas New Indications for ReTUR (HuNIRe) Multicenter Prospective Trial

Abstract

ObjectivesThe aim of this study is to assess whether restaging transurethral resection (ReTUR) could be safely replaced with urine cytology (UC) and in-office fiexible cystoscopy in selected T1 non-muscle-invasive bladder cancer (NMIBC).Materials and MethodsThis is an ongoing prospective multicenter trial enrolling patients diagnosed with T1 BC from 5 Italian centers. Patients with a macroscopically incomplete initial resection or absence of detrusor muscle were subjected to ReTUR according to European Association of Urology (EAU) guidelines. Conversely, those with a complete tumor resection at initial TUR underwent UC at 3–4 weeks and in-office fiexible white-light and narrow-band cystoscopy at 4–6 weeks. In case of positive UC, or evidence of recurrence at cystoscopy, ReTUR was performed within 2 weeks. Otherwise, patients started Bacillus Calmette–Guérin (BCG) induction course without ReTUR. The primary endpoint was to determine the feasibility and the clinical utility of not performing ReTUR in selected T1 NMIBC patients. The secondary endpoint was to perform a cost–benefit analysis of this alternative approach.ResultsSince May 2020, among 87 patients presenting with T1, 76 patients were enrolled. Nineteen (25%) patients underwent standard ReTUR after initial resection, 10 (13.2%) due to the absence of the detrusor muscle and 9 (11.8%) due to a macroscopically incomplete initial TUR. Overall, 57 (75%) patients initially avoided immediate ReTUR and underwent UC plus in-office flexible cystoscopy. Among them, 38 (66.7%) had no evidence of residual disease and immediately started the BCG induction course. Nineteen patients (33.3%) underwent “salvage” ReTUR due to either positive UC (7; 12.3%) or suspicious cystoscopy (12; 21%). Considering only the patients who initially avoided the ReTUR, disease recurrence was observed in 10/57. The saving of resource for each safely avoided ReTUR was estimated to be 1,759 €. Considering the entire sample, we estimated a saving of 855 € per patient if compared with the EAU guideline approach.ConclusionThe preliminary results of our trial suggested that ReTUR might be safely avoided in highly selected T1 BC patients with a complete resection at first TUR. Longer follow-up and larger sample size are needed to investigate the long-term oncological outcomes of this alternative approach.

Clinical and pathological predictors of persistent T1 HG at second resection

“…They found that among those not undergoing the early second resection, only 17.5% experienced recurrence of the disease during the follow-up without evidence of upstaging. 6 These findings support that ReTUR indication should be tailored to the patient risk factors for T1 HG persistence because it is the only solid prognostic indicator. In this scenario, ReTUR might be avoided not only in Ta HG patients that underwent complete first resection with the presence of detrusor muscle in the pathological specimen as prescribed by EAU guidelines, but also in selected small solitary T1 tumors.…”

“…They found that among those not undergoing the early second resection, only 17.5% experienced recurrence of the disease during the follow-up without evidence of upstaging. 6 …”

“… 1 , 5 However, several studies raise doubts about the role of ReTUR in improving long-term oncological outcomes, especially in patients where the first resection is considered complete. 1 , 6 – 8 Considering the evidence suggesting the opportunity to safely avoid the ReTUR in selected cases where the tumor is macroscopically completely removed, we need more clinical and pathological reliable predictors of worse oncological outcomes to stratify T1 HG bladder cancer patients better and consequently differentiate those who might benefit the most from an early ReTUR. 6 Therefore, we sought to assess clinical and pathological predictors associated with the persistence of T1 disease at ReTUR in our retrospective multicentric cohort of T1 HG bladder cancer patients.…”

Differences in oncological benefits from second transurethral resection between white‐light initial surgery and photodynamic diagnosis‐guided initial surgery for primary high‐risk non‐muscle invasive bladder cancer

“…Contieri et al in a multicenter prospective trial investigated whether second TUR could be avoided in patients with T1 NMIBC. 20 In that study, second TUR was initially avoided in 75% of the patients (n = 57) because of the complete resection and presence of detrusor muscle in the resected samples, in 67% of patients (n = 38) who had no evidence of residual tumor in urine cytology and cystoscopy leading to immediate induction of intravesical BCG therapy, and 33% of patients (n = 19) underwent second TUR because they demonstrated positive urine cytology or suspicious lesions under cystoscopy. Of the 57 patients, 10 patients had recurrence after a median followup of 11 months.…”

Healthcare Resource Utilization and Cost Burden of BCG-Treated Non-Muscle Invasive Bladder Cancer Patients in Germany: A Retrospective Claims Analysis

“…overall economic burden of NMIBC treatment and follow-up, in addition to its critical impact on the psychological health and quality of life of patients. 24 Drug costs for the MIBC group were also roughly twice the costs for the NMIBC subgroups. Similar findings have been reported in two studies of cost in NMIBC.…”