GUIDELINES ON NON-MUSCLE INVASIVE (Ta, T1, CIS) BLADDER CANCER

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1 GUIDELINES ON NON-MUSCLE INVSIVE (Ta, T1, CIS) BLDDER CNCER (Text update March 2013) M. Babjuk, M. Burger, R. Zigeuner, S. Shariat, B.W.G. van Rhijn, E. Compérat, R. Sylvester, E. Kaasinen,. Böhle, J. Palou, M. Rouprêt Eur Urol 2011 pr;59(4): Introduction The EU Working Group on Non-muscle-invasive Bladder Cancer has published a short and long version of guidelines on non-muscle-invasive bladder cancer which contains information on its background, classification, risk factors, diagnosis, prognostic factors, and treatment. The current recommendations for non-muscle-invasive bladder cancer are ultra-short and are based on the current literature (until the end of 2012), with emphasis being placed on (evidence based) results from randomised clinical trials and meta-analyses. These guidelines can be used as a quick reference on the management of patients with non-muscleinvasive bladder cancer. The recommendations of this working panel apply to patients with papillary stage Ta and T1 tumours as well as to carcinoma in situ (CIS), a flat neoplasm. The classification of non-muscle-invasive tumours (Ta, T1, and CIS) is given in the TNM Classification of Malignant Tumours, 7th Edition, 2009 (Table 1). Non-muscle invasive (T, T1, CIS) Bladder Cancer 7

2 Table 1: TNM Classification 2009 Urinary Bladder T - Primary Tumour Ta Non-invasive papillary carcinoma CIS (Tis) Carcinoma in situ: flat tumour T1 Tumour invades subepithelial connective tissue T2 Tumour invades muscularis T2a Superficial muscle (inner half) T2b Deep muscle (outer half) T3 Tumour invades perivesical tissue (beyond muscularis) T3a Microscopically T3b Macroscopically (extravesical mass) T4 Tumour invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall T4a Prostate, uterus, or vagina T4b Pelvic wall or abdominal wall N - Lymph Nodes NX Regional lymph nodes cannot be assessed N0 No regional lymph node metatstasis N1 Metastasis in a single lymph node in the true pelvis (hypogastric, obturator, external iliac, or presacral) N2 Mestastasis in multiple lymph nodes in the true pelvis (hypogastric, obturator, external iliac, or presacral) N3 Metastasis in a common iliac lymph node(s) M - Distant Metastasis MX Metastasis not assessed M0 No distant metastasis M1 Distant metastasis 8 Non-muscle invasive (T, T1, CIS) Bladder Cancer

3 Characteristics of Stages Ta, T1, and CIS Stage Ta tumours are confined to the urothelium, have a papillary configuration of their exophytic part, and do not penetrate from the urothelium into the lamina propria or detrusor muscle. Stage T1 tumours originate from the urothelium but penetrate the basement membrane which separates the urothelium from the deeper layers. T1 tumours invade into the lamina propria, but not into the detrusor muscle. Carcinoma in situ (CIS) is a high-grade (anaplastic) carcinoma confined to the urothelium, but with a flat non-papillary configuration. CIS appears as reddened and velvety mucosa, but is sometimes not visible. CIS can be local or diffuse. Four types of CIS are distinguishable: primary CIS (no previous or concurrent papillary tumours, no previous CIS); secondary CIS (with a history of papillary tumours, but not CIS); concurrent CIS (in the presence of papillary tumours in the bladder); recurrent CIS (repeat occurrence of isolated CIS). Characteristics of Grade 1973 WHO Classification part from their architecture, the individual cells show different degrees of anaplasia: Grade 1: well differentiated tumour Grade 2: moderately differentiated tumour Grade 3: poorly differentiated tumour 2004 WHO Classification new classification system was initially proposed by the WHO/ISUP in 1998 and updated by the WHO in For non- Non-muscle invasive (T, T1, CIS) Bladder Cancer 9

4 invasive urothelial neoplasias, the categories described in Table 2 are used. Table 2: 2004 WHO Classification of non-invasive urothelial neoplasia Flat lesions Hyperplasia (flat lesion without atypia or papillary) Reactive atypia (flat lesion with atypia) typia of unknown significance Urothelial dysplasia Urothelial carcinoma in situ (CIS) Papillary lesions Urothelial papilloma (a completely benign lesion) Papillary urothelial neoplasm of low malignant potential (PUNLMP) Low-grade papillary urothelial carcinoma High-grade papillary urothelial carcinoma The 2004 WHO grading system defines CIS as a non-papillary, i.e. a flat, lesion in which the surface epithelium contains cells that are cytologically malignant. Papillary tumours are classified as either papillary urothelial neoplasms of low malignant potential (PUNLMP) or as urothelial carcinomas, with the latter being subdivided into two grades: low grade and high grade (Table 2). The intermediate group (G2) has been eliminated; this group was the subject of controversy in the 1973 WHO classification. Use of the 2004 WHO classification is advocated, as this should result in less diagnostic variability among pathologists. However until the 2004 WHO classification has been validated clinically, both classifications should be used. The majority of clinical trials published so far on Ta, T1 bladder tumours have been performed using the 1973 WHO classifica- 10 Non-muscle invasive (T, T1, CIS) Bladder Cancer

5 tion, and therefore the following guidelines are based on the 1973 WHO grade classification. Diagnosis and Initial Treatment Steps The diagnosis mainly depends on the cystoscopic examination of the bladder, biopsy, and urine cytology. To date, molecular urinary markers have not improved the combination of cystoscopy and cytology. The standard initial therapy for Ta and T1 papillary bladder tumours is complete macroscopic transurethral resection (TURB), including a part of the underlying muscle. TURB should be performed systematically in individual steps, which are described in the full version of the guidelines. Small tumours (< 1 cm) can be resected en bloc including a part of the underlying muscle. Larger tumours should be resected separately in fractions, which include the exophytic part of the tumour, the underlying bladder wall with the detrusor muscle and the edges of the resection area. The specimens from different fractions must be referred to the pathologist in separate containers. second TURB 2-6 weeks after initial resection is recommended in the following situations: after incomplete initial TURB, if there was no muscle in the specimen after initial resection (with exception of Ta low grade (G1) tumours), in all T1 tumours and in all high grade (G3) tumours (except primary CIS). The diagnosis of CIS is based on the histology of biopsies from the bladder wall. Biopsies are taken from suspect areas. In patients with positive urine cytology and no papillary tumour, multiple biopsies from normal looking mucosa including prostatic urethra (random biopsies) are recommended. Fluorescence cystoscopy is recommended in these cases as it Non-muscle invasive (T, T1, CIS) Bladder Cancer 11

6 improves the detection rate of CIS. Urine cytology is an important tool in the diagnosis and follow-up of CIS because of its high sensitivity and specificity (over 90%). CIS cannot be eradicated by TUR and further treatment is mandatory. Prognostic Factors and djuvant Treatment TaT1 papillary tumours It is recommended to stratify patients according to prognostic factors into three risk groups that will facilitate treatment recommendations. Their definition, which takes into account the EORTC risk tables probabilities of recurrence and especially progression, can be found in Table 3. For individual prediction of the risk of tumour recurrence and progression at different intervals after TURB, application of EORTC risk tables and calculator ( is strongly recommended. Table 3: Treatment recommendations in TaT1 tumours according to risk stratification Risk category Definition Treatment recommendation Low-risk tumours Intermediate-risk tumours Primary, solitary, Ta, G1, < 3 cm, no CIS ll cases between categories of low and high risk 12 Non-muscle invasive (T, T1, CIS) Bladder Cancer One immediate instillation of chemotherapy One immediate instillation of chemotherapy followed by further instillations, either chemotherapy for a maximum of 1 year or 1 year full-dose BCG

7 High-risk tumours Subgroup of highest-risk tumours ny of the following: T1 tumours G3 tumours CIS Multiple and recurrent and large (> 3 cm) Ta G1G2 tumours (all these conditions must be presented) T1G3 associated with concurrent bladder CIS, multiple and/or large T1G3 and/ or recurrent T1G3, T1G3 with CIS in prostatic urethra, micropapillary variant of urothelial carcinoma BCG refractory tumours Intravesical fulldose BCG instillations for 1-3 years or radical cystectomy (in highest risk tumours) Radical cystectomy should be considered Radical cystectomy is recommended Since there is considerable risk for recurrence and/or progression of tumours after TURB, adjuvant intravesical therapy is recommended for all stages (Ta, T1, and CIS). Immediate postoperative instillation of chemotherapy within 6 hours after TURB is recommended in tumours presumed to be at low or intermediate risk, except in cases of bladder perforation or severe bleeding. The choice of drug (mitomycin C, epirubicin, or doxorubicine) is optional. The choice of further intravesical adjuvant therapy depends on the patient s risk. Non-muscle invasive (T, T1, CIS) Bladder Cancer 13

8 Intravesical chemotherapy reduces the risk of recurrence but not progression and is associated with minor side-effects. Intravesical immunotherapy with Bacillus Calmette-Guérin (BCG) (induction and maintenance) is superior to intravesical chemotherapy in reducing recurrences and in preventing or delaying progression to muscle-invasive bladder cancer. However, intravesical BCG is more toxic. Recommendations for Low Risk Tumours GR Patients with a single, small, low grade Ta tumour without CIS are at low risk, they should receive: 1. complete TURB. 2. n immediate single post-operative instillation with a chemotherapeutic agent (drug optional). 3. No further treatment is recommended prior to disease recurrence. Recommendations for Intermediate Risk Tumours GR The major issue in the management of intermediate risk tumours is to prevent recurrence and progression, of which disease recurrence is clinically the most frequent. Treatment should include: 1. Complete TURB followed by an immediate postoperative instillation with a chemotherapeutic agent (drug optional). 2. second TURB after 4-6 weeks when indicated. B 3a djuvant intravesical immunotherapy with BCG, 1 year full dose; Or 3b djuvant intravesical chemotherapy (drug optional), schedule: optional although the duration of treatment should not exceed 1 year. 14 Non-muscle invasive (T, T1, CIS) Bladder Cancer

9 Recommendations for High Risk Tumours GR The treatment of Ta, T1 tumours at high risk should consist of: 1. Complete TURB of papillary tumours. C 2. second TURB after 4-6 weeks. B 3. djuvant intravesical immunotherapy with BCG (full dose). Maintenance therapy for 1-3 years is necessary although the optimal maintenance scheme has not yet been determined. 4. Immediate radical cystectomy may be offered to C patients at highest risk of tumour progression. 5. In patients with BCG failure, radical cystectomy is B recommended. Carcinoma in situ CIS has a high risk of progression to muscle-invasive disease which exceeds 50% in some studies. BCG intravesical immunotherapy (induction and maintenance) is superior to intravesical chemotherapy in increasing the complete response rate and the overall percentage of patients remaining tumour free. Moreover, BCG reduces the risk of progression as compared to either intravesical chemotherapy or a different immunotherapy. Early radical cystectomy at the time of diagnosis provides excellent disease-free survival, but over-treatment occurs in up to 50% of patients. Non-muscle invasive (T, T1, CIS) Bladder Cancer 15

10 Recommendations for the treatment of CIS 1. In concurrent CIS, the initial strategy (TURB, early intravesical instillation, a second TURB) is based on the features of the papillary tumour. 2. Intravesical BCG immunotherapy, full dose with 1-3 years of maintenance. 3. fter the 6 week induction course, a second course of 6 weekly BCG instillations or maintenance cycles consisting of 3 weekly instillations may be considered in non responders since about 40-60% of these patients will respond to additional treatment with BCG. 4. In BCG non-responders at 6 months radical cystectomy is recommended. GR B B Follow-up for non-muscle invasive bladder tumours Patients with non-muscle-invasive bladder tumours need to be regularly followed up because of the risk of disease recurrence and progression; however, the frequency and duration of cystoscopies should reflect the degree of risk. When planning a follow-up schedule, the following aspects should be considered: a. The prompt detection of muscle-invasive and high-grade non-muscle-invasive recurrences is critical since a delay in diagnosis and therapy threatens a patient s life. b. Tumour recurrence in the low-risk group is nearly always low stage and low grade. Small, non-invasive (Ta), low grade papillary recurrences do not present an immediate danger to the patient and their early detection is not essential for successful therapy. In these patients, fulguration of small papillary recurrences on an outpatient basis is considered to be a safe treatment option. c. The result of the first cystoscopy after TURB at 3 months is 16 Non-muscle invasive (T, T1, CIS) Bladder Cancer

11 a very important prognostic factor for disease recurrence and for progression. The first cystoscopy should thus always be performed 3 months after TURB. d. The risk of upper urinary tract recurrence increases in patients with multiple and high risk tumours. The following recommendations are only based on retrospective experience. Recommendations for follow-up The follow-up of Ta T1 tumours is based on regular cystoscopy. Patients with low-risk Ta tumours should undergo cystoscopy at 3 months. If negative, subsequent cystoscopy is advised 9 months later, and then yearly for 5 years. Patients with high-risk tumours should undergo cystoscopy and urinary cytology at 3 months. If negative, subsequent cystoscopy and cytology should be repeated every 3 months for a period of 2 years, and every 6 months thereafter until 5 years, and then yearly. Patients with intermediate-risk Ta T1 tumours should have an in-between follow-up scheme using cystoscopy and cytology, which is adapted according to personal and subjective factors. Regular (yearly) upper tract imaging (CT-IVU or IVU) is recommended for high-risk tumours. Endoscopy under anaesthesia and bladder biopsies should be performed when office cystoscopy shows suspicious findings or if urinary cytology is positive. GR C C C C B Non-muscle invasive (T, T1, CIS) Bladder Cancer 17

12 During follow-up in patients with positive cytology and no visible tumour in the bladder, R-biopsies or biopsies with PDD (if equipment is available) and investigation of extravesical locations (CT urography, prostatic urethra biopsy) are recommended. B This short booklet text is based on the more comprehensive EU guidelines (ISBN ), available to all members of the European ssociation of Urology at their website, 18 Non-muscle invasive (T, T1, CIS) Bladder Cancer

13 GUIDELINES ON UROTHELIL CRCINOMS OF THE UPPER URINRY TRCT (UTUCs) (Text update March 2013) M. Rouprêt, M. Babjuk, E. Compérat, R. Zigeuner, R. Sylvester, M. Burger,. Böhle, B.W.G. Van Rhijn, E. Kaasinen, J. Palou, S.F. Shariat Eur Urol 2011 pr;59(4): Introduction UTUCs are uncommon and account for only 5-10% of urothelial cell carcinomas. They have a similar morphology to bladder carcinomas and nearly all UTUCs are urothelial in origin. Classification Table 1: TNM classification 2009 for renal pelvis and ureter T - Primary tumour TX T0 Ta Tis T1 T2 T3 T4 Primary tumour cannot be assessed No evidence of primary tumour Non-invasive papillary carcinoma Carcinoma in situ Tumour invades subepithelial connective tissue Tumour invades muscularis Renal pelvis: tumour invades beyond muscularis into peripelvic fat or renal parenchyma Ureter: tumour invades beyond muscularis into periureteric fat Tumour invades adjacent organs or through the kidney into perinephric fat Urothelial Carcinomas Of The Upper Urinary Tract 19

14 N - Regional lymph nodes NX N0 N1 N2 N3 Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in a single lymph node 2 cm or less in the greatest dimension Metastasis in a single lymph node more than 2 cm but not more than 5 cm in the greatest dimension, or multiple lymph nodes, none more than 5 cm in greatest dimension Metastasis in a lymph node more than 5 cm in greatest dimension M - Distant metastasis M0 M1 No distant metastasis Distant metastasis Tumour grade There are currently two main classifications used for UTUCs. They are the 1973 WHO classification, which classifies tumours into three grades, G1, G2 and G3, and the 2004 WHO classification, which classifies tumours into three groups: papillary urothelial neoplasia of low malignant potential, lowgrade carcinomas, and high-grade carcinomas. Upper urinary tract tumours with low malignant potential are very rare. Diagnosis UTUCs are diagnosed using imaging, cystoscopy, urinary cytology and diagnostic ureteroscopy. The benefits of ureteroscopy in pre-operative assessment should also be discussed with the patient. Recommendations for diagnosis of UTUCs Urinary cytology Cystoscopy to rule out a concomitant bladder tumour CT urography GR 20 Urothelial Carcinomas Of The Upper Urinary Tract

15 Diagnostic ureteroscopy and biopsy Retrograde ureteropyelography C C Prognostic factors UTUCs that invade the muscle wall usually have a very poor prognosis. Recognised prognostic factors in decreasing order of importance include: tumour stage and grade; concomitant carcinoma in situ (CIS); age; lymphovascular invasion; tumour architecture; extensive tumour necrosis; molecular markers; tumour location; and gender. Management Localised disease in UTUCs Radical management (radical nephroureterectomy, RNU) The radical management of UTUCs consists of open surgery RNU with excision of the bladder cuff. This is the gold standard treatment for UTUCs, regardless of tumour location. It includes resection of the distal ureter and its orifice because of the high risk of recurrence in this area. Lymph node dissection is also carried out as part of treatment and to provide optimal staging. Recommendations for radical management (i.e. radical nephroureterectomy) Indications Suspicion of infiltrating UTUC on imaging High-grade tumour (urinary cytology) Multifocality (with two functional kidneys) Non-invasive but large (i.e. > 2 cm) UTUC Choice of technique Open and laparoscopic access are equally effective Bladder cuff removal is imperative GR B B B B B Urothelial Carcinomas Of The Upper Urinary Tract 21

16 Several techniques for bladder cuff excision are acceptable, except stripping Lymphadenectomy is recommended in the case of invasive UTUC Postoperative instillation (chemotherapy) is recommended after RNU to avoid bladder recurrence C C B Conservative management (low-risk UTUCs) Conservative management of low-risk UTUCs consists of surgery preserving the upper urinary renal unit. It is used in imperative cases (renal insufficiency, solitary functional kidney) or in selected elective cases (functional contralateral kidney) for low-grade, low-stage tumours. The choice of technique (ureteroscopy, segmental resection, percutaneous access) depends on technical constraints, the anatomical location of the tumour, and the experience of the surgeon. Recommendations for conservative management (low-risk UTUCs) Indications GR Unifocal tumour B Small tumour (size < 1 cm) B Low-grade tumour (cytology or biopsies) B No evidence of an infiltrative lesion on CT urography B Understanding of close follow-up B Techniques Laser should be used in the case of endoscopic C treatment Flexible ureteroscopy is preferable to rigid C ureteroscopy percutaneous approach is an option for small, lowgrade, caliceal tumours unsuitable for ureteroscopic C treatment 22 Urothelial Carcinomas Of The Upper Urinary Tract

17 Ureteroureterostomy is an option for non-invasive, low-grade tumours of the proximal ureter or mid-ureter that cannot be removed completely by endoscopic means Complete distal ureterectomy and neocystostomy is an option for non-invasive, low-grade tumours in the distal ureter that cannot be removed completely by endoscopic means C C The instillation of Bacillus Calmette-Guérin (BCG) or mitomycin C in the urinary tract by percutaneous nephrostomy or via a ureteric stent is technically feasible after conservative treatment of UTUCs. However, the benefits have not been confirmed. dvanced disease in UTUCs RNU has no benefit in metastatic (M+) disease, but may be used in palliative care. s UTUCs are urothelial tumours, platinum-based chemotherapy should give similar results to those in bladder cancer. Currently, insufficient data are available to provide any recommendations. Radiotherapy is scarcely relevant nowadays both as a unique therapy and associated with chemotherapy as a tumour adjuvant. Follow-up after initial treatment In all cases, there should be strict follow-up after radical management to detect metachronous bladder tumours, as well as invasive tumours, local recurrence and distant metastases. In conservative management, the ipsilateral upper urinary tract requires careful follow-up due to the high risk of recurrence. Urothelial Carcinomas Of The Upper Urinary Tract 23

18 Recommendation fter radical management, over at least 5 years Non-invasive tumour Cystoscopy/urinary cytology at 3 months and then annually CT every year Invasive tumour Cystoscopy/urinary cytology at 3 months and then annually CT urography every 6 months for 2 years and then annually fter conservative management, over at least 5 years Urinary cytology and CT urography at 3 months, 6 months and then annually Cystoscopy, ureteroscopy and cytology in situ at 3 months, 6 months, every 6 months for 2 years and then annually GR C C C C C C 24 Urothelial Carcinomas Of The Upper Urinary Tract

19 Figure 1: Proposed flowchart for the management of UTUC UTUC Diagnostics evaluation: CT-urography, urinary cytology, cystoscopy retrograde pyelography +/- flexible ureteroscopy with biopsies Gold standard treatment: Radical nephroureterectomy - Unifocal tumour - Size < 1 cm - Low-grade tumour - Superficial aspect on CT-urography Open Laparoscopic Conservative management: ureteroscopy, segmental resection Close and stringent follow-up Recurrence This short booklet text is based on the more comprehensive EU guidelines (ISBN: ), available to all members of the European ssociation of Urology at their website, Urothelial Carcinomas Of The Upper Urinary Tract 25

20 MUSCLE-INVSIVE ND METSTTIC BLDDER CNCER (Text update March 2013) J.. Witjes (chair), E. Compérat, N.C. Cowan, G. Gakis, M. De Santis, T. Lebret, M.J. Ribal,. Sherif Eur Urol 2011 Jun;59(6): Introduction Optimal treatment strategies for MIBC require the involvement of a specialist multidisciplinary team and a model of integrated care to avoid fragmentation of patient care. Staging system The UICC 2009 TNM (Tumour, Node, Metastasis Classification) is used for staging. 26 Muscle-invasive and Metastatic Bladder Cancer

21 Table 1: 2009 TNM classification of urinary bladder cancer T - Primary tumour TX T0 Ta Tis T1 T2 T3 T4 Primary tumour cannot be assessed No evidence of primary tumour Non-invasive papillary carcinoma Carcinoma in situ: flat tumour Tumour invades subepithelial connective tissue Tumour invades muscle T2a Tumour invades superficial muscle (inner half) T2b Tumour invades deep muscle (outer half) Tumour invades perivesical tissue T3a Microscopically T3b Microscopically (extravesical mass) Tumour invades any of the following: prostate, uterus, vagina, pelvic wall, abdominal wall T4a Tumour invades prostate, uterus or vagina T4b Tumour invades pelvic wall or abdominal wall N - Lymph nodes NX N0 N1 N2 N3 M - Distant metastasis M0 M1 Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in a single lymph node in the true pelvis (hypogastric, obturator, external iliac or presacral) Metastasis in multiple lymph nodes in the true pelvis (hypogastric, obturator, external iliac or presacral) Metastasis in a common iliac lymph node(s) No distant metastasis Distant metastasis Muscle-invasive and Metastatic Bladder Cancer 27

22 Table 2: WHO grading 1973 and 2004 (Both classifications are used for the current guidelines since most of the retrospective studies were based on the old WHO 1973 grading system) WHO grading Urothelial papilloma Grade 1: well differentiated Grade 2: moderately differentiated Grade 3: poorly differentiated 2004 WHO grading Urothelial papilloma Papillary urothelial neoplasm of low malignant potential (PUNLMP) Low-grade papillary urothelial carcinoma High-grade papillary urothelial carcinoma Morphological subtypes can be important for helping with prognosis and treatment decisions. Currently the following differentiation is used: 1. Urothelial carcinoma (more than 90% of all cases) 2. Urothelial carcinomas with squamous and/or glandular partial differentiation 3. Micropapillary urothelial carcinoma 4. Nested carcinoma 5. Some urothelial carcinomas with trophoblastic differentiation 6. Small cell carcinomas 7. Spindle cell carcinomas. Recommendations for assessing tumour specimens Mandatory evaluations Histological subtype Depth of invasion Resection margins, including CIS 28 Muscle-invasive and Metastatic Bladder Cancer

23 Extensive lymph-node representation Optional evaluation Bladder wall blood vessel invasion CIS, carcinoma in situ. Specific recommendations for primary assessment of presumably invasive bladder tumours (General information for assessment of bladder tumours, see EU Guidelines on Non-muscle-invasive Bladder cancer) Recommendations GR Cystoscopy should describe all macroscopic features C of the tumour (site, size, number and appearance) and mucosal abnormalities. bladder diagram is recommended. Biopsy of the prostatic urethra is recommended for C cases of bladder neck tumour, when bladder CIS is present or suspected, when there is positive cytology without evidence of tumour in the bladder, or when abnormalities of the prostatic urethra are visible. If biopsy is not performed during the initial procedure, it should be completed at the time of the second resection. In women undergoing a subsequent orthotopic neobladder, procedure information is required (including a C histological evaluation) of the bladder neck and urethral margin, either prior to, or at the time of cystoscopy. The pathological report should specify the grade, the C depth of tumour invasion and whether the lamina propria and muscle tissue are present in the specimen. Muscle-invasive and Metastatic Bladder Cancer 29

24 Recommendations for staging of MIBC In patients with confirmed muscle-invasive bladder cancer, CT of the chest, abdomen and pelvis is the optimal form of staging, including excretory-phase CT urography for complete examination of the upper urinary tracts. Excretory-phase CT urography is preferred to MR urography for diagnosing UTUCs in terms of greater diagnostic accuracy, less cost, and greater patient acceptability. MR urography is used when CT urography is contra-indicated for reasons related to contrast administration or radiation dose. Ureteroscopic-guided biopsy is recommended for histopathological confirmation of diagnosis in the preoperative assessment of UTUC. CT or MRI is recommended for staging locally advanced or metastatic disease in patients in whom radical treatment is being considered. CT and MRI are generally equivalent in diagnosing local and distant abdominal metastases but CT is preferred to diagnose pulmonary metastases. GR B C C C C Treatment failure of non-muscle invasive bladder tumours Recommendations for treatment failure of non-muscle-invasive bladder cancer GR In all T1 tumours at high risk of progression (i.e. high B grade, multifocality, carcinoma in situ, and tumour size, as outlined in the EU guidelines for Non-muscleinvasive bladder cancer), immediate radical treatment is an option. In all T1 patients failing intravesical therapy, radical B treatment should be offered. 30 Muscle-invasive and Metastatic Bladder Cancer

25 Muscle-invasive bladder cancer - Radical Surgery and Urinary Diversion Conclusions For muscle-invasive bladder cancer radical cystectomy is the curative treatment of choice. higher case load reduces morbidity and mortality of cystectomy. There is data to support that an extended LND (versus a standard or limited LND) improves survival after radical cystectomy. Radical cystectomy in both sexes must not include the removal of the entire urethra in all cases, which may then serve as outlet for an orthotopic bladder substitution. Terminal ileum and colon are the intestinal segments of choice for urinary diversion. The type of urinary diversion does not affect oncological outcome. Laparoscopic and robotic-assisted laparoscopic cystectomy is feasible but still investigational. In patients with invasive bladder cancer older than 80 years cystectomy is an option. Surgical outcome is influenced by comorbidity, age, previous treatment for bladder cancer or other pelvic diseases, surgeon and hospital volumes of cystectomy, and type of urinary diversion. Surgical complications of cystectomy and urinary diversion should be reported in a uniform grading system. Currently, the best-adapted, graded system for cystectomy is the Clavien grading system. LE Contraindications for orthotopic bladder substitution are Muscle-invasive and Metastatic Bladder Cancer 31

26 positive margins at the level of urethral dissection, positive margins anywhere on the bladder specimen (in both sexes), if the primary tumour is located at the bladder neck or in the urethra (in women), or if tumour extensively infiltrates the prostate (in men). Recommendations for radical cystectomy GR Radical cystectomy is recommended in T2-T4a, N0 * M0, and high risk non-muscle-invasive BC. Do not delay cystectomy more than 3 months since it B increases the risk of progression and cancer-specific death. Pre-operative radiotherapy is not recommended in case of subsequent cystectomy with urinary diversion. Lymph node dissection should be an integral part of B cystectomy. n extended LND is recommended. The urethra can be preserved if margins are negative. B If no bladder substitution is attached, the urethra must be checked regularly. Laparoscopic and robot-assisted laparoscopic cystectomy are both options. However, current data have C not sufficiently proven the advantages or disadvantages for both oncological and functional outcomes of laparoscopic and robotic-assisted laparoscopic cystectomy. Before cystectomy, the patient should be fully B informed about the benefits and potential risks of all possible alternatives, and the final decision should be based on a balanced discussion between patient and surgeon. 32 Muscle-invasive and Metastatic Bladder Cancer

27 The decision regarding bladder sparing or radical cystectomy in the elderly/geriatric patient with invasive bladder cancer should be based on tumour stage and comorbidity best quantified by a validated score, such as the Charlson score. Pre-operative bowel preparation is not mandatory, fast track measurements may reduce the time of bowel recovery. n orthotopic bladder substitute should be offered to male and female patients lacking any contraindications and who have no tumour in the urethra and at the level of urethral dissection. *Upgraded following panel consensus B C B Neoadjuvant chemotherapy Neoadjuvant cisplatin-containing combination chemotherapy improves overall survival, irrespective of the type of definitive treatment (LE: 1a). It has its limitations regarding patient selection, current development of surgical technique, and current chemotherapy combinations. In current routine clinical practice, it is difficult to select patients who will respond to neoadjuvant chemotherapy due to the lack of an applicable test. In the future, genetic markers, in a personalized medicine setting, are expected to make it easier to select patients for treatment and to differentiate responders from non-responders. Recommendations Neoadjuvant chemotherapy is recommended for T2-T4a, cn0m0 bladder cancer and should always be cisplatinum-based combination therapy. Neoadjuvant chemotherapy is not recommended in patients with PS 2 and/or impaired renal function. In case of progression under neoadjuvant chemotherapy, this treatment should be discontinued. GR B Muscle-invasive and Metastatic Bladder Cancer 33

28 Fig. 1: Flowchart for the management for T2-T4a N0M0 urothelial bladder cancer Diagnosis Cystoscopy and tumour resection Evaluation of urethra CT imaging of abdomen, chest, UUT MR can be used for local staging 1 - males: biopsy apical prostatic urethra or frozen section during surgery 1 - females: biopsy of proximal urethra or frozen section during surgery Findings: pt2-3, clinical N0M0 urothelial carcinoma of the bladder pt2n0m0 selected patients - Multimodality bladder sparing therapy can be considered for T2 tumours (Note: alternative, not the standard option) Neoadjuvant chemotherapy Should be considered in selected patients 5-7% 5 year survival benefit 2 - neoadjuvant radiotherapy is not recommended Radical cystectomy Know general aspects of surgery o Preparation o Surgical technique o Integrated node dissection o Urinary diversion o Timing of surgery higher case load improves outcome Direct adjuvant chemotherapy Not indicated after cystectomy Bladder-sparing treatments for localised disease Transurethral resection of bladder tumour (TURB) TURB alone is only possible as a therapeutic option if tumour growth is limited to the superficial muscle layer and if re-staging biopsies are negative for residual tumour. External beam radiotherapy External beam radiotherapy alone should only be consid- 34 Muscle-invasive and Metastatic Bladder Cancer

29 ered as a therapeutic option when the patient is unfit for cystectomy or a multimodality bladder-preserving approach. Radiotherapy can also be used to stop bleeding from the tumour when local control cannot be achieved by transurethral manipulation because of extensive local tumour growth (LE: 3). Surgically non-curable tumours Palliative cystectomy for metastatic disease Primary radical cystectomy in T4b bladder cancer is not a curative option. If there are symptoms, radical cystectomy may be a therapeutic/palliative option. Intestinal or non-intestinal forms of urinary diversion can be used, with or without, palliative cystectomy. Recommendations LE GR In patients with inoperable locally advanced B tumours (T4b), primary radical cystectomy is a palliative option and cannot be offered as curative treatment. In patients with symptoms palliative cystectomy may be offered. Prior to any further interventions, surgeryrelated morbidity and quality-of-life should be fully discussed with the patient. 3 B Chemotherapy and best supportive care With cisplatin-based chemotherapy as primary therapy for locally advanced tumours in highly selected patients, complete and partial local responses have been reported. (LE: 2b). Recommendation Chemotherapy alone is not recommended as primary therapy for localised bladder cancer. GR Muscle-invasive and Metastatic Bladder Cancer 35

30 djuvant Chemotherapy Neither randomized trials nor a meta-analysis have provided sufficient data to support the routine use of adjuvant chemotherapy (LE: 1a). Recommendation djuvant chemotherapy is advised within clinical trials, but not as a routine therapeutic option. GR Multimodality treatment Conclusions In a highly selected patient population, long-term survival rates of multimodality treatment are comparable to those of early cystectomy. Delay in surgical therapy can compromise survival rates. LE 3 2b Recommendations Transurethral resection of bladder tumour (TURB) alone cannot be offered as a standard curative treatment option in most patients. Radiotherapy alone is less effective than surgery and is only recommended as a therapeutic option when the patient is unfit for cystectomy or a multimodality bladder-preserving approach. Chemotherapy alone is not recommended as primary therapy for muscle-invasive bladder cancer. Surgical intervention or multimodality treatment are the preferred curative therapeutic approaches since they are more effective than radiotherapy alone. GR B B B 36 Muscle-invasive and Metastatic Bladder Cancer

31 Multimodality treatment could be offered as an alternative in selected, well-informed, well selected and compliant patients, especially for whom cystectomy is not an option. B Metastatic disease Conclusions for metastatic disease LE In a first-line setting, PS and the presence or absence 1b of visceral metastases are independent prognostic factors for survival. In a second-line setting, prognostic factors are: liver 2 metastasis, PS and haemoglobin (< 10 g/dl) Cisplatin-containing combination chemotherapy can 1b achieve median survival of up to 14 months, with longterm disease-free survival reported in ~15% of patients with nodal disease and good PS. Carboplatin combination chemotherapy is less 2a effective than cisplatin-based chemotherapy in terms of complete response and survival. There is no defined standard chemotherapy for unfit 2b patients with advanced or metastatic urothelial cancer. Vinflunine reached the highest level of evidence ever 1b reported for second-line use. Post-chemotherapy surgery after partial or complete 3 response may contribute to long-term disease-free survival. Zoledronic acid and denosumab have been approved 1 for all cancer types including urothelial cancer, because they reduce and delay SREs in metastatic bone disease. Muscle-invasive and Metastatic Bladder Cancer 37

32 Recommendations for metastatic disease GR First-line treatment for fit patients: Use cisplatin-containing combination chemotherapy with GC, PCG, MVC, preferably with G-CSF, or HD-MVC with G-CSF. Carboplatin and non-platinum combination chemotherapy is not recommended. B First-line treatment in patients ineligible (unfit) for cisplatin: For cisplatin-ineligible (unfit) patients, with PS2 or impaired renal function, as well as those with 0-1 poor Bajorin prognostic factors and impaired renal function, treatment with carboplatin-containing combination chemotherapy, preferably with gemcitabine/ carboplatin is indicated. Second-line treatment: In patients progressing after platinum-based B* combination chemotherapy for metastatic disease, vinflunine should be offered. lternatively, treatment within a clinical trial setting may be offered. Zoledronic acid or denosumab is recommended for B treatment of bone metastases. *Upgraded to Grade B recommendation; data not reaching statistical significance. Recommendation for the use of biomarkers Currently, no biomarkers can be recommended in daily clinical practice since they have no impact on predicting outcome, treatment decisions or monitoring therapy in muscle-invasive bladder cancer. *Upgraded following panel consensus. GR * 38 Muscle-invasive and Metastatic Bladder Cancer

33 Fig. 2: Flowchart for the management of metastatic urothelial cancer Patient characteristics: PS 0-1/ 2/ >2 GFR >/< 60mL/min Comorbidities C I S P L T I N? YES NO NO PS 0-1 and GFR > 60mL/min STNDRD GC MVC HD MVC PS 2 or GFR < 60mL/min comb. chemo: Carbo- based PS > 2 and GFR < 60mL/min NO comb.chemo studies, monotherapy, BSC Second-line treatment PS 0-1 PS > 2 1. Progression > 6-12 months after first-line chemotherapy, adequate renal function a. re-exposition to first line treatment (cisplatin based) b. clinical study 2. Progression > 6-12 months after first-line chemotherapy, PS 0-1, impaired renal function a. Vinflunine b. clinical study 3. Progression < 6-12 months after first-line chemotherapy, PS 0-1 a. Vinflunine b. clinical study a. best supportive care b. clinical study Muscle-invasive and Metastatic Bladder Cancer 39

34 Health-related quality-of-life (HRQoL) Important determinants of (subjective) quality of life are a patient s personality, coping style and social support. Recommendations for HRQoL GR The use of validated questionnaires is recommended B to assess HRQoL in patients with muscle-invasive bladder cancer. Unless a patient s co-morbidities, tumour variables C and coping abilities present clear contra-indications, a continent urinary diversion should be offered. Pre-operative patient information, patient selection, C surgical techniques, and careful post-operative followup are the cornerstones for achieving good long-term results. Patient should be encouraged to take active part in C the decision-making process. Clear and exhaustive information on all potential benefits and side-effects should be provided, allowing them to make informed decisions. This short booklet text is based on the more comprehensive EU guidelines (ISBN ), available to all members of the European ssociation of Urology at their website, 40 Muscle-invasive and Metastatic Bladder Cancer

35 GUIDELINES ON PROSTTE CNCER (Text update February 2012). Heidenreich (chairman), P.J. Bastian, J. Bellmunt, M. Bolla, S. Joniau, T.H. van der Kwast, M.D. Mason, V. Matveev, N. Mottet, T. Wiegel, F. Zattoni Eur Urol 2008 Jan;53(1):68-80 Eur Urol 2011 Jan;59(1):61-71 Eur Urol 2011 pr;59(4): Introduction Cancer of the prostate (PCa) is currently the second most common cause of cancer death in men. In developed countries PCa accounts for 15% of male cancers compared with 4% of male cancers in developing countries. Within Europe exist also large regional differences in the incidence rates of PCa. There are three well-established risk factors for PCa: increasing age, ethnic origin, and genetic predisposition. Clinical data suggest that exogenous risk factors, such as diet, pattern of sexual behaviour, alcohol consumption, exposure to ultraviolet radiation, and occupational exposure may also play an important role in the risk of developing PCa. The introduction of an effective blood test, prostate-specific antigen (PS), has resulted in more early-stage prostate cancer diagnosis where potentially curative treatment options can be provided. However, if effective diagnostic procedures are inappropriately used in elderly men with a short life span, the issue of over-diagnosis and over-treatment may occur. Consequently, the same stage of prostate cancer may require Prostate Cancer 41

36 different treatment strategies depending on an individual patient s life expectancy. Staging system The 7 th edition Union Internationale Contre le Cancer (UICC) 2009 Tumour Node Metastasis (TNM) classification is used for staging (Table 1). Table 1: Tumour Node Metastasis (TNM) classification of cancer of the prostate T - Primary tumour TX T0 T1 T2 T3 T4 Primary tumour cannot be assessed No evidence of primary tumour Clinically unapparent tumour not palpable or visible by imaging T1a Tumour incidental histological finding in 5% or less of tissue resected T1b Tumour incidental histological finding in more than 5% of tissue resected T1c Tumour identified by needle biopsy (e.g. because of elevated PS level) Tumour confined within the prostate 1 T2a Tumour involves one half of one lobe or less T2b Tumour involves more than half of one lobe, but not both lobes T2c Tumour involves both lobes Tumour extends through the prostatic capsule 2 T3a Extracapsular extension (unilateral or bilateral) T3b Tumour invades seminal vesicle(s) Tumour is fixed or invades adjacent structures other than seminal vesicles: external sphinter, rectum, levator ani and/or pelvic wall 42 Prostate Cancer

37 N - Regional lymph nodes 3 NX N0 N1 Regional lymph nodes cannot be assessed No regional lymph node metastasis Regional lymph node metastasis M - Distant metastasis 4 M0 M1 No distant metastasis Distant metastasis M1a Non-regional lymph node(s) M1b Bone(s) M1c Other site(s) 1 Tumour found in one or both lobes by needle biopsy, but not palpable or visible by imaging, is classified as T1c. 2 Invasion into the prostatic apex, or into (but not beyond) the prostatic capsule, is not classified as T3, but as T2. 3 The regional lymph nodes are the nodes of the true pelvis, which are essentially the pelvic nodes below the bifurcation of the common iliac arteries. Laterality does not affect the N classification. 4 When more than one site of metastasis is present, the most advanced category should be used. Gleason grading system The most commonly used system for grading PCa is the Gleason grading system. Diagnosis and staging The decision whether to proceed with further diagnostic or staging work-up is guided by which treatment options are available to the patient, taking the patient s age and comorbidity into consideration. Procedures that will not affect the treatment decision can usually be avoided. Synoptic reporting of surgical specimens results in more Prostate Cancer 43

38 transparent and more complete pathology reporting. The use of a checklist is encouraged and two examples are presented here. Checklist for pathology reporting of prostate biopsies 1. Histological type of carcinoma 2. Histological grade (global or highest) Primary grade Secondary (= highest) grade 3. Fraction of involved cores Number of cores involved by carcinoma Total number of cores 4. Tumour quantification Percentage of prostatic tissue involved by carcinoma or total mm of cancer length 5. Tumour extent Identification of perineural invasion Identification of extra-prostatic extension Identification of seminal vesicle invasion Checklist for processing and pathology reporting of radical prostatectomy (RP) specimens 1. Processing of RP specimens Total embedding of a prostatectomy specimen is preferred, either by conventional (quadrant sectioning) or by whole-mount sectioning The entire surface of RP specimens should be inked before cutting in order to evaluate the surgical margin status The apex should be separately examined using the cone method with sagittal or radial sectioning 2. Histological type 3. Histological grade Primary (predominant) grade Secondary grade 44 Prostate Cancer

39 Tertiary grade (if exceeding > 5% of PCa volume) Global Gleason score pproximate percentage of Gleason grade 4 or 5 (optional) 4. Tumour quantification (optional) Percentage of prostatic tissue involved Tumour size of dominant nodule (if identified), greatest dimension in mm 5. Pathological staging (ptnm) Presence of extraprostatic extension (focal or extensive), specify sites Presence of seminal vesicle invasion Presence of lymph node metastases, number of retrieved lymph nodes and number of positive lymph nodes 6. Surgical margins Presence of carcinoma at margin If present, specify site(s) and extra- or intra-prostatic invasion 7. Other If identified, presence of angioinvasion Location (site, zone) of dominant tumour (optional) Perineural invasion (optional) If present, specify extra- or intra-prostatic invasion short summary of the guidelines on diagnosis and staging of PCa are presented below. Prostate Cancer 45

40 Guidelines for the diagnosis and staging of PCa Diagnosis of PCa 1. n abnormal digital rectal examination (DRE) result or elevated serum PS measurement could indicate PCa. The exact cut-off level of what is considered to be a normal PS value has yet to be determined, but values of approximately < 2-3 ng/ml are often used for younger men. 2. The diagnosis of PCa depends on histopathological (or cytological) confirmation. Biopsy and further staging investigations are only indicated if they affect the management of the patient. 3. Transrectal ultrasound (TRUS)-guided systemic biopsy is the recommended method in most cases of suspected PCa. t least 8 systemic, laterally directed cores are recommended, with perhaps more cores in larger volume prostates. Transition zone biopsies are not recommended in the first set of biopsies due to low detection rates. One set of repeat biopsies is warranted in cases with persistent indication for PCa (abnormal DRE, elevated PS or histopathological findings suggestive of malignancy at the initial biopsy). Overall recommendations for further (three or more) sets of biopsies cannot be made; the decision must be made based on an individual patient. GR C B C B C B C 46 Prostate Cancer

41 4. Transrectal peri-prostatic injection with a local anaesthetic can be offered to patients as effective analgesia when undergoing prostate biopsies. Staging of PCa 1. Local staging (T-staging) of PCa should be based on magnetic resonance imaging (MRI). Further information is provided by the number and sites of positive prostate biopsies, the tumour grade and the level of serum PS. Despite its high specificity in the evaluation of extraprostatic extension (EPE) and seminal vesicle invasion or involvement (SVI), TRUS is limited by poor contrast resolution, resulting in low sensitivity and a tendency to understage PCa. Even with the advent of colour- and power Doppler to assist in identifying tumour vascularity, the accuracy of TRUS in local staging remains inadequate. In comparison with DRE, TRUS and computed tomography (CT), MRI demonstrates higher accuracy for the assessment of uni- or bi-lobar disease (T2), EPE and SVI (T3), as well as the invasion of adjacent structures (T4). The addition of dynamic contrast-enhanced MRI (DCE-MRI) can be helpful in equivocal cases. The addition of magnetic resonance spectroscopic imaging (MRSI) to MRI also increases accuracy and decreases inter-observer variability in the evaluation of EPE. C C Prostate Cancer 47

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