Early radical cystectomy in NMIBC Marko Babjuk Dept. of Urology, 2nd Faculty of Medicine, Hospital Motol, Praha, Czech Republic
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Prognosis of NMIBC? T1G3 (HG) tumors? High risk of progression Risk of progression of T1G3 : 5 17% at 1 year and 17-45% at 5 years
If we decide for cystectomy, what can we achieve?
Cystectomy Long-term follow-up in large number of patients!! OS and DFS Low risk of late recurrences Good local control - local recurrence in 10-12% Improvement in techniques of urinary diversion with better QOL
Our data: Patients characteristics N 550 (394 + 156) Age Mean 61.86 (21-83) Period 1.1.1993 31.8.2012 (1.1.2008-31.8.2012) Gender 403 M, 147 F Follow-up Median 1.88 Y (0.0 18.46) Survival correlated with deaths registry of Czech Republic
Cystectomy oncological results 5-year disease-free survival (DFS) = 48.1 68 % Strongly dependent from the local extent of the disease and from lymph node involvement Stein, J Clin Oncol, 2001, 19, 666 No chemo, Hautmann, 2012, Eur Urol Shariat, 2006, J Urol
DSS according to T,N T0-2N0 x T3,4N0 x TxN1,2 P<0.0001
Cystectomy outcome in pt1 tumors
Treatment of T1G3 When indicate cystectomy? 2 concepts: Immediate radical cystectomy (immediatelly after detection) BCG and early (deferred) radical cystectomy at the time of BCG failure Which approach is better???
Can BCG reduce the risk of progression?
but
Prognosis in BCG treated T1G3
Prognosis of BCG treated T1G3 1062 pts. from 3 CUETO trials
PFS in BCG treated T1 PFS: Grade 1+2 vs. 3 p=0,0282 Significant No. of patients will progress in spite of BCG
Prognosis of high risk NMIBC? Cancer, 2012, 118, 5525 712 pts. with primary HR NMIBC between 1994 and 2010 1 in 4 pts. progress, it is difficult to predict progression Progression dramatically worsens survival
2820 pts. (only 16% G3), follow-up 4.4 Yr In BCG maintenance, 32% reduction in the risk of recurrence No significant difference in progression and survival Based on available data we cannot conclude that BCG prevents long-term progression
5-year DSS 55% in primary and 28% in invasive group Poor prognosis in patients with invasive BC and history of NMIBC We should not wait with cystectomy untill tumor became muscle invasive
Prognosis of patients with recurrence after Cx BJU I, 2012, 111, 1545 pts. after Cx for UC Over 2/3 die during 12 Mo Prognosis of patients with recurrence after Cx is fatal
Can we select patients with the worst prognosis of T1G3? High quality TURB High quality of pathological evaluation Discussion with the patient
Recommendation Careful TURB as an initial and crucial step: Stratified resection including muscle PDD if available or consider R biopsies Prostatic urethra biopsy retur in 2-6 weeks in T1, G3 and in the absence of muscle Pathology: Stage, grade T1 substaging Lymphovascular invasion Unusual pathologies
Additional risk factors in T1G3 when (immediate) cystectomy should be considered CIS Multifocality Hydronephrosis >3 cm Deeply invasive T1 Positive prostatic urethra LVI Unusual pathologies T1 on restaging TURB
If you decide for cystectomy, how you should do that? (to achieve optimal oncological and functional results?)
How can we achieve optimal oncological results with cystectomy? Timely indication Adequate extent of surgery (negative margins, lymph node dissection, urethrectomy?) Concentration in experienced hands and high-volume centers
How can we define the extent of LND? Anatomic landmarks Limited LND (obturator fossa) Standard LND (below common iliac artery bifurcation) Extended LND (up to inferior mesenteric artery) Superextended LND Is LND necessary in cystectomy for NMIBC?
Must be LND performed in all stages? In the same template? Correlation of pt and pn+ in our data pt % pts with N+ pta, pt1, ptis 2.6 pt2a 7.8 pt2b 17.0 pt3a 25.9 pt3b 40.0 pt4 48.5
LND according to stage? BJU International, 2011 11183 pts from SEER database LND more often ommited in Ta-T2 tumors Benefitial effect of PLND in all stages!!!
Primary lymphatic landing sites Supports the theory of meticulous pelvic LND only
LND template: up to the mid-upper third of common iliac vessels
How can we achieve optimal oncological results? Timely indication Adequate extent of surgery Concentration in experienced hands and high-volume centers
Concentration in experienced hands and high-volume centers Criteria of success: Oncological results Morbidity and mortality QOL (diversion etc.)
Postoperative mortality and morbidity Period N (%) 30d 17 (3,15%) 60d 23 (4,28%) 90d 31 (5,85%) Analysis of 171 cases operated between 1/2008 and 2/2013: Period Mortality Morbidity 30d 3 (1,75%) 50.3 % 90d 4 (2,34%) 55.6 % Experience with increasing number of pts. Program of preoperative and postoparetive care (no bowel prep, early oral nutrition, early mobilisation Early bowel recovery New technologies Shorter operation time Less blood loss
Urinary diversion X
Functional results 113 pts, not regular nerve sparing Fully incontinent 15%, fully continent 18% Day-time fully continent 68%, regular pads only 9% Night-time fully continent 23%, 15% fully incontinent Erection in 24% Careful communication and selection of patients What can we do better?
Nerve-sparing radical cystectomy and orthotopic diversion in men Negative surgical margin Better early continence Better erection (40-60%) Oncologically safe Kessler, J Urol, 2004, 172, 1323 Hekal, Eur Urol, 2009, 55, 275
Seminal vesicle preservation
Urethra sparing cystectomy and orthotopic diversion Attempt to preserve the autonomic nerves to urethra Resection of 0.5-1 cm of proximal urethra
Conclusions Cystectomy should be performed before muscle invasive progression Crucial role of endoscopy in high risk NMIBC In highest risk patients immediate cystectomy should be considered Early cystectomy in BCG failure High quality of performed cystectomy!!! New technologies in the future? Robotics?