Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial

Itoh, Akihiro; Shintaku, Ichiro; Satoh, Makoto; Ioritani, Naomasa; Aizawa, Mamoru; Tochigi, Tatsuo; Kawamura, Sadafumi; Aoki, Hiroshi; Numata, Isao; Takeda, Atsushi; Namiki, Shunichi; Namima, Takashige; Ikeda, Yoshihiro; Kambe, Koichi; Kyan, Atsushi; Ueno, Seıjı; Orikasa, Kazuhiko; Katoh, Shinichiro; Adachi, Hisanobu; Tokuyama, Satoru; Ishidoya, Shigeto; Yamaguchi, Takuhiro; Arai, Yoichi

doi:10.1200/jco.2012.45.2128

Cited by 200 publications

(161 citation statements)

References 26 publications

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“…Previously, few available methods could prevent bladder tumour recurrence. Up to date, randomized controlled trial studies showed that a single dose of intravesical instillation following RNU appeared to reduce the risk of developing a bladder cancer, with a low risk of complications (6,7). However, at least one-half of the patients do not have recurrence of bladder tumours in the subsequent years, especially in primary UTUC, and so there may be over-treatment.…”

Section: Introductionmentioning

confidence: 99%

Low-level Ki-67 expression as an independent predictor of bladder tumour recurrence in patients with primary upper tract urothelial carcinoma after radical nephroureterectomy

Liu

Zhang

et al. 2015

Jpn. J. Clin. Oncol.

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Objective: To evaluate the association of molecular markers and conventional clinicopathological factors with bladder tumour recurrence in patients with primary upper tract urothelial carcinoma after radical nephroureterectomy. Methods: The expressions of Ki-67 and P53 were measured by immunohistochemical staining prospectively in 115 consecutive patients with primary upper tract urothelial carcinoma from March 2004 to February 2014. The Cox proportional hazards regression model was used to identify independent predictors. The association between Ki-67 expression and clinicopathological variables was assessed by the χ 2 test.Results: Intravesical recurrence occurred in 13 out of 115 (11.3%) patients with a mean follow-up of 54.2 months (range: 7-130). Low-level Ki-67 expression (P = 0.010), older age (>65, P = 0.040) and lower ureter tumour (P = 0.001) were independent predictors of bladder tumour recurrence in Cox regression analysis. Ki-67 expression was elevated with the progression of tumour grade (P = 0.004) but not with stage (P = 0.186). Ki-67 overexpression was also significantly higher in aggressive pathological types (P = 0.008), but only shows an inclination towards poor oncologic outcomes in the cancer-specific survival rate (P = 0.107) and the overall survival rate (P = 0.063).Conclusions: Low-level Ki-67 expression was an independent predictor for bladder tumour recurrence, while Ki-67 overexpression was associated with adverse clinicopathological parameters and poor prognosis in patients with primary upper tract urothelial carcinoma after radical nephroureterectomy.

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Section: Introductionmentioning

confidence: 99%

Low-level Ki-67 expression as an independent predictor of bladder tumour recurrence in patients with primary upper tract urothelial carcinoma after radical nephroureterectomy

Liu

Zhang

et al. 2015

Jpn. J. Clin. Oncol.

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“…[35][36][37] It is unknown how the use of postoperative intravesical chemotherapy will affect these results.…”

Section: Discussionmentioning

confidence: 99%

The impact of method of distal ureter management during radical nephroureterectomy on tumour recurrence

Kapoor

Dason

Allard

et al. 2014

CUAJ

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Introduction: Radical nephroureterectomy for upper tract urothelial carcinoma (UTUC) must include some form of distal ureter management to avoid high rates of tumour recurrence. It is uncertain which distal ureter management technique has the best oncologic outcomes. To determine which distal ureter management technique resulted in the lowest tumour recurrence rate, we analyzed a multiinstitutional Canadian radical nephroureterectomy database. Methods: We retrospectively analyzed patients who underwent radical nephroureterectomy with distal ureter management for UTUC between January 1990 and June 2010 at 10 Canadian tertiary hospitals. Distal ureter management approaches were divided into 3 categories: (1) extravesical tenting for ureteric excision without cystotomy (EXTRAVESICAL); (2) open cystotomy with intravesical bladder cuff excision (INTRAVESICAL); and (3) extravesical excision with endoscopic management of ureteric orifice (ENDOSCOPIC). Data available for each patient included demographic details, distal ureter management approach, pathology and operative details, as well as the presence and location of local or distant recurrence. Clinical outcomes included overall recurrence-free survival and intravesical recurrence-free survival. Survival analysis was performed with the Kaplan-Meier method. Multivariable Cox regression analysis was also performed. Results: A total of 820 patients underwent radical nephroureterectomy with a specified distal ureter management approach at 10 Canadian academic institutions. The mean patient age was 69.6 years and the median follow-up was 24.6 months. Of the 820 patients, 406 (49.5%) underwent INTRAVESICAL, 316 (38.5%) underwent EXTRAVESICAL, and 98 (11.9%) underwent ENDOSOPIC distal ureter management. Groups differed significantly in their proportion of females, proportion of laparoscopic cases, presence of carcinoma in situ and pathological tumour stage (p < 0.05). Recurrence-free survival at 5 years was 46.3%, 35.6%, and 30.1% for INTRAVESICAL, EXTRAVESICAL and ENDOSCOPIC, respectively (p < 0.05). Multivariable Cox regression analysis confirmed that INTRAVESICAL resulted in a lower hazard of recurrence compared to EXTRAVESICAL and ENDOSCOPIC. When looking only at intravesical recurrence-free survival (iRFS), a similar trend held up with INTRAVESICAL having the highest iRFS, followed by ENDOSCOPIC and then EXTRAVESICAL management (p < 0.05). At last follow-up, 406 (49.5%) patients were alive and free of disease. Conclusion: Open intravesical excision of the distal ureter (INTRAVESICAL) during radical nephroureterectomy was associated with improved overall and intravesical recurrence-free survival compared with extravesical and endoscopic approaches. These findings suggest that INTRAVESICAL should be considered the gold standard oncologic approach to distal ureter management during radical nephroureterectomy. Limitations of this study include its retrospective design, heterogeneous cohort, and limited follow-up.

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“…As with non-muscle-invasive Bca, prophylactic intravesical chemotherapy was also shown to be effective in preventing bladder recurrence after RNU in several prospective randomized studies [19][20][21] . However, there is no consensus on the optimal chemotherapy regimen or on the initial To evaluate the efficacies of different chemotherapy regimens in different risk sub-groups for the prevention of bladder recurrence after RNU, we stratified patients based on 4 risk factors for bladder recurrence after RNU.…”

Section: Discussionmentioning

confidence: 99%

Prevention of Recurrent Bladder Tumors after Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinoma: An Individualized Selection Strategy Based on Patient Risk Stratification Is Needed

Long

et al. 2016

Urol Int

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Objective: To evaluate the efficacies of different chemotherapy regimens in different risk sub-groups for the prevention of bladder recurrence after radical nephroureterectomy (RNU). Materials and Methods: Between 2004 and 2012, we recruited 685 patients who underwent RNU for upper tract urothelial carcinoma at 4 Chinese institutions. We assessed whether the type of intravesical chemotherapy regimen affected the bladder recurrence rate in patients with different risk levels after RNU. Results: For all patients, the bladder recurrence rate was lower with intravesical chemotherapy than without, but no significant differences were found between the 2 intravesical chemotherapy regimens (single dose or relatively long-term therapy). We used multivariate analysis to define the risk factors for bladder recurrence and stratified patients into low-, intermediate-, and high-risk sub-groups accordingly. The bladder recurrence rate in the low-risk patients was not significantly different between patients with or without intravesical chemotherapy. However, in the intermediate-risk and high-risk patients, the rate was greater in patients without intravesical chemotherapy than in patients with. Furthermore, the rate was not significantly different between the 2 intravesical chemotherapy regimens in the intermediate-risk patients, while the efficacy of the relatively long-term regimen in high-risk patients remains unclear. Conclusions: Our study showed that an individualized strategy based on patient risk stratification is needed.

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Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial

Abstract: In this prospective randomized phase II study, a single intravesical instillation of THP seemed to reduce bladder recurrence after nephroureterectomy. A phase III, large-scale, multicenter study is needed to confirm these observations.

Cited by 200 publications

References 26 publications

Low-level Ki-67 expression as an independent predictor of bladder tumour recurrence in patients with primary upper tract urothelial carcinoma after radical nephroureterectomy

Low-level Ki-67 expression as an independent predictor of bladder tumour recurrence in patients with primary upper tract urothelial carcinoma after radical nephroureterectomy

The impact of method of distal ureter management during radical nephroureterectomy on tumour recurrence

Prevention of Recurrent Bladder Tumors after Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinoma: An Individualized Selection Strategy Based on Patient Risk Stratification Is Needed

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