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European Urology
Volume 58, issue 2, pages e19-e28, August 2010Bladder Cancer
Reply from Authors re: Marko Babjuk. Second Resection for Non-Muscle-Invasive Bladder Carcinoma: Current Role and Future Perspectives. Eur Urol 2010;58:191–2 and Giacomo Novara, Vincenzo Ficarra. Does Routine Second Transurethral Resection Affect the Long-Term Outcome of Patients with T1 Bladder Cancer? Why a Flawed Randomized Controlled Trial Cannot Address the Issue. Eur Urol 2010;58:193–4
Rauf Taner Divrik a 
, Ali F. Şahin a, Gül Ergör b.
Published online 8 May 2010, pages 195 - 196
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Refers to article:
Does Routine Second Transurethral Resection Affect the Long-Term Outcome of Patients with T1 Bladder Cancer? Why a Flawed Randomized Controlled Trial Cannot Address the Issue
August 2010 (Vol. 58, Issue 2, pages 193 - 194)
Refers to article:
Impact of Routine Second Transurethral Resection on the Long-Term Outcome of Patients with Newly Diagnosed pT1 Urothelial Carcinoma with Respect to Recurrence, Progression Rate, and Disease-Specific Survival: A Prospective Randomised Clinical Trial
Accepted 3 March 2010
August 2010 (Vol. 58, Issue 2, pages 185 - 190)
Refers to article:
Second Resection for Non-Muscle-Invasive Bladder Carcinoma: Current Role and Future Perspectives
August 2010 (Vol. 58, Issue 2, pages 191 - 192)
Article Outline
1. Introduction
The effect and quality of transurethral resection (TUR) is usually underappreciated, although it is the initial and critical step in the management of bladder tumours. We would like to thank Babjuk [1], and Novara and Ficarra [2] for their emphasis on our recent published study that underscores this issue [3]. Their views have inspired some additional comments and given us another opportunity to discuss our study and its methodology.
2. Design and methodology of the study
We recently updated the paper that published our preliminary outcomes in May 2006 [4]. We would have liked to describe the methodology and study design in detail in the manuscript without addressing previous papers; however, because of length restrictions, we were not able to present the design of the study in detail. The method of randomisation and sample size calculation were not described, which often happens with trials published in the urologic literature owing to word-count limitations.
2.1. Method of randomisation
All consecutive primary pT1 patients suitable for the inclusion criteria and accepted to participate in the study were included. Patients were randomised into two groups by a computer-generated, randomly numbered list.
2.2. Sample size calculation
At the beginning of the study, we calculated sample size as 114 (57 for each group; α = 0.05; power: 90%) by accepting the recurrence rates of 60% for no second TUR and 30% for second TUR. There were no previous data related to the impact of second TUR on recurrence and progression of T1 disease at the time of the study design. Furthermore, it was unclear how many new T1 tumours would be detected and how many patients would agree to participate in the study, so we considered the time interval for including patients. To date, there is no data related to the impact of second TUR on the progression of T1 disease. By using our results (7% for second TUR and 21% for no second TUR; α = 0.05; sample size: 93 vs 98), the power of the study was calculated to be 80.25%.
2.3. Primary and secondary end points
It was mentioned in our previous paper [4] that “The end points used to assess the efficacy of the treatment of groups were the time to histologically confirmed bladder cancer recurrence (RFS) and to progression to muscle-invasive disease and/or presence of CIS [carcinoma in situ].” The primary end points were RFS and progression-free survival. Secondary end points were the number of cystectomies, disease-specific and overall survival, presence of residual tumour at second TUR, and tumour upstaging.
3. Results
After the second TUR, eight patients upstaged to T2 were treated with cystectomy, and four patients with CIS were treated with bacillus Calmette-Guérin instillation. These 12 patients were excluded according to the study design. For the T2 tumours at the time of diagnosis, we decided not to mention recurrence and progression during the follow-up. We believed that we should not compare the different stages of the disease (T2 vs T1) according to recurrence and progression. We took into account the eight upstaged patients when comparing the number of patients between groups who underwent cystectomy.
3.1. Intention-to-treat analysis
Novara and Ficarra [2] mentioned that the reduced risk of recurrence and progression could be explained by exclusion of the patients in both arms. Owing to the intention-to-treat analysis suggested by the authors, it is clear that in either the best or worst scenario, a significant difference is maintained (Table 1). We believe that exclusion of patients with pT2/CIS should not be considered as a bias favouring the second TUR group [3]. In this paper, the quality of TUR is questioned. The superiority of second TUR to no second TUR on recurrence and progression is investigated. It is expected that patients with T2 and/or CIS will be misdiagnosed in the no second TUR group.
Table 1
Intention-to-treat analyses
| Recent study | Best scenario | Worst scenario | |||||
|---|---|---|---|---|---|---|---|
| 2nd TUR | TUR | 2nd TUR | TUR | 2nd TUR | TUR | ||
| Recurrence | n | 37/93 | 70/98 | 37/105 | 70/105 | 49/105 | 77/105 |
| % | 39.8 | 71.4 | 35.2 | 66.7 | 46.7 | 73.3 | |
| p values | 0.0001 | 0.0001 | 0.0001 | ||||
| Progression | n | 6/93 | 23/98 | 6/105 | 23/105 | 18/105 | 30/105 |
| % | 6.5 | 23.5 | 5.7 | 21.9 | 17.1 | 28.6 | |
| p values | 0.001 | 0.001 | 0.049 | ||||
| Cystectomy | n | 14/101 | 23/98 | 6/105 | 23/105 | 18/105 | 30/105 |
| % | 13.3 | 23.5 | 5.7 | 21.9 | 17.1 | 28.6 | |
| p values | 0.031 | 0.001 | 0.049 | ||||
4. Conclusions
Two important messages should be taken from this study [3]. First, because of the complexities of definitions, both the rate of the residual tumour and understaging after the second TUR were reported with a range of 28–74% and 1.7–64%, respectively, in different studies [3]. The TUR after incomplete resection resulting from factors such as multiplicity, size, and location has to be called repeat resection. If a second intervention is done to provide additional pathologic information for the muscularis propria, it has to be called restaging TUR. The term second TUR should be used only if the procedure were done after complete and correct TUR.
Second, we have clearly shown that the second TUR, which is performed only after complete first TUR, has significantly decreased the recurrence and progression rates in patients with newly diagnosed T1 disease compared with patients with T1 disease who have not undergone second TUR.
Conflicts of interest
The authors have nothing to disclose.
References
- [1] M. Babjuk. Second resection for non-muscle-invasive bladder carcinoma: current role and future perspectives. Eur Urol 58 (2010) (191 - 192) Abstract, Full-text, PDF, Crossref.
- [2] G. Novara, V. Ficarra. Does routine second transurethral resection affect the long-term outcome of patients with T1 bladder cancer? Why a flawed randomized controlled trial cannot address the issue. Eur Urol 58 (2010) (193 - 194) Abstract, Full-text, PDF, Crossref.
- [3] R.T. Divrik, A.F. Şahin, Ü. Yildirim, M. Altok, F. Zorlu. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol 58 (2010) (185 - 190) Abstract, Full-text, PDF, Crossref.
- [4] R.T. Divrik, U. Yildirim, F. Zorlu, H. Ozen. The effect of repeat transurethral resection on recurrence and progression rates in patients with T1 tumors of the bladder who received intravesical mitomycin: a prospective, randomized clinical trial. J Urol 175 (2006) (1641 - 1644) Crossref.
Footnotes
a Department of Urology, SB Tepecik Research and Training Hospital, Izmir, Turkey
b Department of Public Health, Dokuz Eylül University School of Medicine, Izmir, Turkey
Corresponding author. SB Tepecik Research and Training Hospital, Department of Urology, Gaziler cad, Yenisehir, Izmir, 35100 Turkey. Tel. +905323248000; Fax: +902324330756.
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