Transurethral En Bloc Resection Versus Standard Resection of Bladder Tumour: A Randomised, Multicentre, Phase 3 Trial,European Urology

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Transurethral En Bloc Resection Versus Standard Resection of Bladder Tumour: A Randomised, Multicentre, Phase 3 Trial
European Urology ( IF 25.3 ) Pub Date : 2024-04-30 , DOI: 10.1016/j.eururo.2024.04.015
Jeremy Yuen-Chun Teoh ₁ , Cheung-Hing Cheng ₂ , Chiu-Fung Tsang ₃ , Joseph Kai-Man Li ₁ , Bryan Kwun-Chung Cheng ₄ , Wilson Hoi-Chak Chan ₄ , Wayne Kwun-Wai Chan ₅ , Trevor Churk-Fai Li ₆ , Yi Chiu ₇ , Man-Chung Law ₈ , Clarence Lok-Hei Leung ₅ , Brian Sze-Ho Ho ₃ , Chris Yue-Kit Lee ₂ , Ronald Cheong-Kin Chan ₉ , Eddie Shu-Yin Chan ₁₀ , Marco Tsz-Yeung Chan ₂ , James Hok-Leung Tsu ₃ , Ho-Man Tam ₁ , Kin-Man Lam ₄ , Hing-Shing So ₄ , Chak-Lam Cho ₅ , Chi-Man Ng ₆ , Chun-Ki Chan ₇ , Pak-Ling Liu ₈ , Ringo Wing-Hong Chu ₅ , Ada Tsui-Lin Ng ₃ , Sau-Kwan Chu ₂ , Chi-Hang Yee ₁ , Ming-Kwong Yiu ₃ , Ka-Lun Lo ₁ , Wing-Hang Au ₆ , Wai-Kit Ma ₇ , Peter Ka-Fung Chiu ₁ , Hilda Sze-Wan Kwok ₁ , Siu-Ying Yip ₁₀ , Chi-Ho Leung ₁₀ , Chi-Fai Ng ₁ ,

Affiliation

S.H. Ho Urology Centre, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Division of Urology, Department of Surgery, North District Hospital, Hong Kong.
Division of Urology, Department of Surgery, Pok Oi Hospital, Hong Kong; Division of Urology, Department of Surgery, Tuen Mun Hospital, Hong Kong.
Division of Urology, Department of Surgery, Tung Wah Hospital, Hong Kong; Division of Urology, Department of Surgery, Queen Mary Hospital, The University of Hong Kong, Hong Kong.
Division of Urology, Department of Surgery, Tseung Kwan O Hospital, Hong Kong; Division of Urology, Department of Surgery, United Christian Hospital, Hong Kong.
Division of Urology, Department of Surgery, Our Lady of Maryknoll Hospital, Hong Kong; Division of Urology, Department of Surgery, Kwong Wah Hospital, Hong Kong.
Division of Urology, Department of Surgery, Queen Elizabeth Hospital, Hong Kong.
Division of Urology, Department of Surgery, Princess Margaret Hospital, Hong Kong.
Division of Urology, Department of Surgery, Caritas Medical Centre, Hong Kong.
Department of Anatomical and Cellular Pathology, The Chinese University of Hong Kong, Hong Kong.
S.H. Ho Urology Centre, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.

Conventionally, standard resection (SR) is performed by resecting the bladder tumour in a piecemeal manner. En bloc resection of the bladder tumour (ERBT) has been proposed as an alternative technique in treating non–muscle-invasive bladder cancer (NMIBC). The objective of this study is to investigate whether ERBT could improve the 1-yr recurrence rate of NMIBC, as compared with SR. A multicentre, randomised, phase 3 trial was conducted in Hong Kong. Adults with bladder tumour(s) of ≤ 3cm were enrolled from April 2017 to December 2020, and followed up until 1 yr after surgery. Patients were randomly assigned to receive either ERBT or SR in a 1:1 ratio. The primary outcome was 1-yr recurrence rate. A modified intention-to-treat analysis on patients with histologically confirmed NMIBC was performed. The main secondary outcomes included detrusor muscle sampling rate, operative time, hospital stay, 30-d complications, any residual or upstaging of disease upon second-look transurethral resection, and 1-yr progression rate. A total of 350 patients underwent randomisation, and 276 patients were histologically confirmed to have NMIBC. At 1 yr, 31 patients in the ERBT group and 46 in the SR group developed recurrence; the Kaplan-Meier estimate of 1- yr recurrence rates were 29% (95% confidence interval, 18–37) in the ERBT group and 38% (95% confidence interval, 28–46) in the SR group ( = 0.007). Upon a subgroup analysis, patients with 1–3 cm tumour, single tumour, Ta disease, or intermediate-risk NMIBC had a significant benefit from ERBT. None of the patients in the ERBT group and three patients in the SR group developed progression to muscle-invasive bladder cancer; the Kaplan-Meier estimates of 1-yr progression rates were 0% in the ERBT group and 2.6% (95% confidence interval, 0–5.5) in the SR group ( = 0.065). The median operative time was 28 min (interquartile range, 20–45) in the ERBT group and 22 min (interquartile range, 15–30) in the SR group ( < 0.001). All other secondary outcomes were similar in the two groups. In patients with NMIBC of ≤ 3cm, ERBT resulted in a significant reduction in the 1-yr recurrence rate when compared with SR. The study results support ERBT as the first-line surgical treatment for patients with bladder tumours of≤ 3cm.

更新日期：2024-04-30

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