UZ Leuven

European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Bolla M, Van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M. Lancet 2005;366(9485):572-8. Abstract: BACKGROUND: Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomised controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. METHODS: After undergoing radical retropubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pN0M0 tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat. FINDINGS: The median age was 65 years (IQR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5; p <0.0001). Clinical progression-free survival was also significantly improved (p=0.0009). The cumulative rate of locoregional failure was significantly lower in the irradiated group (p<0.0001). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (p=0.0005), but severe toxic toxicity (grade 3 or higher) were rare, with a 5- year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (p=0.0726). INTERPRETATION: Immediate external irradiation after radical prostatectomy improves biochemical progression-free survival and local control in patients with positive surgical margins or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the effect on overall survival.

Radical prostatectomy for locally advanced prostate cancer: Results of a feasibility study (EORTC 30001). Van Poppel H, Vekemans K, Da Pozzo L, Bono A, Kliment J, Montironi R, Debois M, Collette L. Eur J Cancer 2006;42(8):1062-7. Epub 2006 Apr 18. Abstract: The aim of this open, non-randomised, 2-stage feasibility study was to determine whether radical prostatectomy (RP) was safe and could provide cure for good prognosis patients with clinical T3 prostate cancer, in a multicentre setting. Cure was defined as a 3 months post-operative of undetectable serum PSA in combination with the presence of pathologically negative margins in the surgical specimen. Forty patients were enrolled of whom 38 were eligible. Six patients (5 pN+ and 1 pNx) did not meet the inclusion criteria and were excluded leaving 32 evaluable pN0 patients of whom 19 (59.4%, SE=4.26) achieved a complete response (CR) and in whom only two serious toxic events (STEs) were observed. The results of the first phase of the study passed the toxicity criteria (<3 STE’s) but failed on the cure rate (/>20 CRs). This resulted in discontinuation of the study after the first stage. The main reason for failure was the incidence of positive margins in the resected specimen. Although the study was stopped after the first phase, 28 of the 32 pN0 patients (87.5%) had undetectable serum PSA at 3 months. We continue to believe that RP with extensive resection can be beneficial as monotherapy for T3aN0M0 prostate cancer.  

Microscopic vascular invasion is the most relevant prognosticator after radical nephrectomy for clinically nonmetastatic renal cell carcinoma. Van Poppel H, Vandendriessche H, Boel K, Mertens V, Goethuys H, Haustermans K, Van Damme B, Baert L. J Urol 1997;158(1):45-9. Abstract: PURPOSE: Although many factors have been considered to predict the outcome after radical nephrectomy, renal cell carcinoma continues to behave unpredictably. In a retrospective study the correlation between microvascular tumor invasion and diseasefree survival after surgery for renal cell carcinoma was analyzed. MATERIALS AND METHODS: Between 1980 and 1993, 180 patients (mean age 60 years) were followed for a mean of 52 months after radical or partial nephrectomy for clinically localized renal cell carcinoma. The relevance of microscopic vascular invasion was compared to classical tumor staging, grade and tumor diameter. RESULTS: Microscopic vascular invasion was found in 51 patients (28.3%), including 20 (39.2%) with progression (mean interval to progression 72 months). Of 129 patients with no pathological evidence of microscopic vascular invasion only 8 (6.2%) showed progression at a mean interval of more than 160 months. The difference in disease-free survival as a function of microvascular invasion was statistically highly significant (log rank p < 0.00001) and on multivariate analysis this parameter was by far the most relevant predictor of progression. CONCLUSIONS: In patients who underwent radical nephrectomy for clinically nonmetastatic renal cell carcinoma with microvascular invasion but without lymph node involvement or macroscopic vascular invasion the chance of disease progression is estimated at 45% within 1 year. Microvascular invasion is the single most relevant prognosticator after presumed curative radical nephrectomy for renal cell carcinoma.

Clinical experience with the N-shaped ileal neobladder: assessment of complications, voiding patterns, and quality of life in our series of 58 patients. Joniau S, Benijts J, Van Kampen M, De Waele M, Ooms J, Van Cleynenbreugel B, Van Poppel H. Eur Urol 2005;47(5):666-72; discussion 672-3. Epub 2005 Jan 20. Abstract: PURPOSE: The purpose of this retrospective study was to assess complications, voiding patterns, and quality of life in patients with an orthotopic bladder substitution, using an N-shaped ileal neobladder. MATERIALS AND METHODS: Between May 1996 and December 2002, 58 patients (52 men and 6 women) underwent an orthotopic ileal neobladder reconstruction after radical cystectomy. The mean age was 47 for the female and 60 for the male patients. In all patients an N-shaped ileal pouch was constructed. This pouch has not yet been described in the literature before. All procedures were performed by the same surgeon (HVP) and the mean follow-up was 38 months. Complications were registered as early (occurring within 3 months) or late (occurring after 3 months), and as pouch-related and non-pouch-related. The patients took part in a pelvic floor re-education programme for as long as they were incontinent. All patients completed a retrospective Quality of Life questionnaire, based on the QLQ-C30 questionnaire, which was validated by the EORTC’s Study Group on Quality of Life. RESULTS: In 38% of the patients, early complications occurred, whereas 48% had late complications. The most frequent early complications were diarrhea (24%) and pyelonephritis (9%). Diarrhea was again the most frequently mentioned non-pouchrelated complication (19%). The most frequently observed pouch-related late complication was ileourethral stenosis. This occurred in five patients. All of these 5 patients were re-operated using a minimally invasive approach. Daytime continence was achieved in 95% of patients and nighttime continence in 66%. Hyper-continence with subsequent need for CISC was observed in 5 out of 6 women (83%) and 0 out of 52 men (0%). The retrospective QoL questionnaire learned that the impact of bladder removal and orthotopic bladder substitution has acceptable impact on patient’s everyday life. Diarrhea was mentioned as being the most discomforting complication by most of the patients. CONCLUSIONS: We describe a modified orthotopic ileal neobladder: the ileal N-pouch. The functional results with this pouch are good. Complication rates and QoL are comparable with the larger series published by other authors, using different ileal neobladder reconstructions

The indications for partial nephrectomy in the treatment of renal cell carcinoma. Nat Clin Pract Urol 2006;3(4):198- 205. Joniau S, Vander Eeckt K, Van Poppel H. Abstract: Partial nephrectomy is performed more frequently for small, incidentally discovered, low-stage renal tumors. Importantly, one should distinguish the imperative indications for such surgery from the relative and elective indications, while taking contraindications to nephron-sparing surgery into account. The main advantage of partial nephrectomy over radical nephrectomy is the avoidance of renal insufficiency; the major disadvantages include the possibility of local recurrence and perioperative complications. In this article, the literature on nephron-sparing surgery was reviewed in order to put the management of renal cancer into a modern perspective.

Effect of pelvic-floor reeducation on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Lancet. 2000 Jan 8;355(9198):98-102. Abstract: BACKGROUND: Urinary incontinence is a common long-term complication after radical prostatectomy. Spontaneous recovery of normal urinary control after surgery can take 1-2 years. We aimed to investigate whether there was any beneficial effect of pelvic-floor re-education for patients with urinary incontinence as a result of radical prostatectomy. METHODS: 102 consecutive incontinent patients who had had radical retropubic prostatectomy for clinically localised prostate cancer and who could comply with the ambulatory treatment schedule in our hospital were randomised, after catheter removal, into a treatment group (n=50) and a control group (n=52). Patients in the treatment group took part in a pelvic-floor re-education programme for as long as they were incontinent, and for a maximum of 1 year. The control group received placebo therapy. The primary endpoint was continence rate at 3 months. Incontinence was assessed objectively with the 1 h and 24 h pad tests and subjectively by the visual analogue scale. The groups were analysed on an intention-to-treat basis by ANOVA and chi2-test. FINDINGS: In the treatment group continence was achieved after 3 months in 43 (88%) of 48 patients. In the control group, continence returned after 3 months in 29 (56%) of 52 patients. At 1 year, the difference in proportion between treatment and control group was 14% (95% CI 2-27). In the treatment group improvement in both duration (log-rank test, p=0.0001) and degree of incontinence (Wald test, p=0.0010) was significantly better than in the control group. INTERPRETATION: Pelvic-floor reeducation should be considered as a first-line option in curing incontinence after radical prostatectomy.

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