Miles Mannas PGY3 University of British Columbia Department of Urology. Objectives
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1 Treatment of Upper Tract Urothelial Carcinoma: A Focus on Alternatives and Adjuvants to the Mantra Heal With Steel Miles Mannas PGY3 University of British Columbia Department of Urology Objectives Introduction Diagnostics Nephron Sparing Techniques Upper Tract Chemotherapy Radical Nephroureterectomy Lymphadenectomy Chemotherapy And Risk Stratification 1
2 Brief Introduction 5-10% of Urothelial Carcinoma occurs in upper tract (UT) UT recurrence in contralateral kidney 2-6% Classic carcinogens: tobacco, work related aromatic hydrocarbons, analgesia abuse, cyclophosphamide etc Average duration of carcinogen exposure 7 years with up to 20 year latency Mixed variant histology in up to 20% of cases Hematuria is the most common presentation, with flank pain much less common Colin et al. BJUI Bladder Versus Upper Tract 2:1 M:F, while bladder is 4:1 Gender is NOT associated with CSM Likely similar yet different tumourigenesis Aristolochic acid and Blackfoot disease Conditions or anatomy that would increase dwell time of toxins are NOT RF for UTUC Lynch Syndrome Type II Prevalence of specific mutations differs between UT and UCB UTUC vs UCB for FGFR3, HRAS, CDKN2B 36.8% and 21.6% respectively UTUC vs UCB for TP53, ARID1A 24.6% and 57.8% respectively More frequent promoter methylation of tumour suppressors in UTUC, 94% vs 76% 10-20% hereditary background Inherent anatomic difficulty with staging Assessment through resection and examination; ~20-32% upstaging at surgery for ureteric lesions 60% UTUC invasive at diagnosis vs 15-25% UCB Green et al. J Urol Mandalapu et al. World J Urol Roupret et al. Eurol Urol Szarvas et al. Trans Androl and Uro
3 Aristolocholic Acid Chinese herb induced nephropathy Aristolachia fangchi Endemic to Balkens, Balken nephropathy D-aristoloctam causes specific mutation in p53 gene; specific mutation rare in unexposed patients Bilateral cases and lack of male predominance One case series showed ~46% of patients with ESRD due to Aristolachia fangchi developed UTUC Colin et al. BJUI Lynch Syndrome Type II associated with CRC and extra-colonic cancers UTUC 3 rd most common tumor at 5-6% RR of developing varies from AD transmission, associated with mutation in DNA mismatch repair (MMR) genes 7x more common with MSH2 then MSH1 Microsatellite Instability Loss of function of MMR genes Replication errors and frame shifts High levels in UTUC ~46% High MSI has improved prognosis with T2-3N0M0, compared to low MSI Colin et al. Transl Androl Urol Li et al. Curr Urol Rep
4 Investigations Roupret et al. Euro UroL Diagnostics Cytology +ve, bladder and prostate negative is suggestive Less sensitive for UTUC, most sensitive in renal pelvis and with high grade Overall PPV 47% and NPV 58% Difficult scenario is positive ureteral wash in context of bladder cytology positive Retrograde Pyelogram Sensitivity of 0.97, specificity of 0.93, a PPV of 0.79 and NPV of 0.99 Ureteroscopy Classically ~20% non-diagnostic, improving with new tech Upstaging in 28-32% of patients re-biopsied and ~45% after Radical Nephroureterectomy (RNU) Cowan et al. BJU international Roupret et al. Eurouro Cutress et al. BJUI Al-Qahtani et al. Urol Int
5 Diagnostic Biopsy Diagnostic - BIGopsy Improved diagnostic rates compared to classic biopsy tools Limits Limited flow Limited visibility Decreased handling and flexibility Cost Al-Qahtani et al. Urol Int
6 Diagnostic - BIGopsy Radiologic Diagnostics CT Urography Remains gold standard PPV 76-90% and NPV 67-80% Can help predict grade and stage Greater degree of spiculation/irregularity correlates with HG or T2, high interobserver variability Endoluminal US Ureteroscopy with Ultrasound to assess for invasion PPV 100%, NPV 66.7% Difficult with bulky tumours if system non-distended Golan et al. BMC Urology Mammen et al. J Comput Assist Tomogr Roupret et al. Eurouro Matin et al. J Ultrasound Med
7 Radiologic Diagnostics - MR Lower ADC values more likely malignant and higher grade cancers ADC values did not allow discrimination of extramuscular extension DWI can help differentiate T stage (differentiating T2, T3a and T3b) Yoshida et al. American Journal of Roentgenology Roy et al. American Journal of Roentgenology Akita et al. American Journal of Roentgenology High resolution imaging analogous to US Uses backscattered light to produce cross-sectional imaging, instead of sound Akin to confocal microscopy URS, Biopsy è RNU or Segmental ureterectomy 26 patients with inclusion criteria; more advanced UTUC Non-diagnostic for CIS Grade: Sens 87%, Spec 90% Stage: Sens 100%, Spec 92% Stage Grade Bus et al. J Urol
8 Nephron Sparing Surgery Preferred approach for low risk disease Must be able to ablate all tumour NOT compromising oncologic outcomes Equal OS and CSS 10 yr recurrence free 21% at 10yrs when pooled Renal unit survival: G1 96%, G2 71% and G3 20%; 83% for all grades combined Requires close follow-up Cutress et al. J Urol Roupret et al. Eur Urol Yakoubi et al. EJSO Treatment - Endoscopic Ablation Coagulation Bugbee Laser Ablation/Coagulation Holmium:YAG Neodynium:YAG Thulium:YAG Percutaneous Laser Coagulation: Monopolar or Bipolar cautery 8
9 Treatment - Lasers Emilliani et al. World J Urol Holmium: YAG The Workhorse in Urology Vaporization of water creates steam bubble used to separate tissue layers by tearing them apart (pulsed) Appropriate tissue penetration ~400μm Normal renal pelvis urothelium 1000μm deep Most familiar and widely used for many purposes Kramer et al. World J Urol Mitterberger et al. Ultraschall Med
10 Neodymium: YAG Neodymium:YAG Coagulative effect Full trans-mural tissue ablation Beamed tissue becomes fluffy, whitish pale and sloughs off over several days Multiple studies have used this laser to ablate bulk of tumor before using Holmium:YAG to resect residual tumor Possible increased risk of ureteric strictures with coagulation in ureter Concern regarding depth of penetration μm Bowel injury with UCB treatment Kramer et al. World J Urol Mugiya et al. Int J Urol Tada et al. BJUI Thulium: YAG New kid on the block Initial experience for treatment of BPH and Urothelial Ca within bladder. Main effects through water. Continuous output allows smooth incision and vaporization with excellent hemostasis μm depth of penetration Non-inferior recurrence free survival to Holmium:YAG Compared to Holmium:yag, may have better performance score in fiber-tip stability, precision, reducing bleeding and mucousal perforation reduction Some concern regarding temperature, both In-vitro and Invivo studies show temperature increases not physiologically harmful Defidio et al. Arch Ital Urol Androl Kallidonis et al. Journal of Endourology Kramer et al. World J Urol
11 Treatment - Percutaneous Indicated for low grade Urothelial carcinoma that can be ineffectively treated with Ureteroscopy alone, usually due to tumour volume, location, or renal anatomy May also be an option for a solitary kidney where alternative would usually be RNU è dialysis Depth of effect with monopolar cautery 300um and bipolar cautery 160um Cutress et al 27% complication rate 17% transfusion, 2% AKI requiring dialysis, 1% emergency RNU or Embolization Seeding tract ~0.3%, risk factor?high grade Cutress et al. BJUI Treatment - Percutaneous 11
12 Retrospective, 27 patients with 28 renal units Ta/T1 without CIS; Nephrostomy or Ureteric Catheter Nephrostomy matured for two weeks before use, change q3mo Office cystoscopically placed ureteric catheter, with local anesthetic, under fluoroscopic guidance and secured to a foley Treated by nurse in ambulatory office setting, slow infusion over 2 hours Controlled by Manometry pressure at or below 20-30mmHg Patients rolled q15-20min Prophylactic antibiotics given for 1-2 doses with each treatment Induction once weekly for 6 weeks, one maintenance course consisted of monthly treatment for at least 3 months or weekly for 3 weeks; without dehydration or alkalization Metcalfe et al. J Endourol Upper Tract MMC Elective patients were treated with curative intent and had a normal contralateral upper tract and normal renal function. Imperative patients were treated with curative intent and had bilateral tumors, tumor in a solitary kidney, or chronic kidney disease, defined as estimated GFR (egfr) < 60. Palliative patients were treated with the goal of local control for maintenance of renal function. Metcalfe et al. J Endo Urol
13 Upper Tract MMC Lynch Syndrome type II per Amsterdam criteria II, tissue or genetic testing Follow-up q3mo for 1 year, then q6mo for at least 2 years Ureteroscopy, urine cytology, chemisty panel, CBC, Tri-phasic CT (possible substitution for MR or retrograde pyelogram) Maintenance courses completed: 1 = 60.7% and 2 = 35.7% 3 year primary outcomes PFS 80% LG and 67% HG RFS 62% for LG and 60% HG NUxFS 76%: 82% LG and 67% HG; for grade or volume progression; none T stage CS mortality 0%, OS 92.9% Metcalfe et al. J Endo Urol Upper Tract MMC Well tolerated 14% adverse event No treatment discontinuation Unclear etiology of stricture, as many possible factors Metcalfe et al. J Endourol
14 MitoGel an aqueous mixture of polymers with reverse-thermal properties and Mitomycin C Liquid at room temp, with increased viscosity at body temperature staying in this state for several hours Antegrade instillation Blood sampling to assess systemic absorption, several orders of magnitude below toxic levels; No analysis of urine MMC concentrations Interval and survival nephrectomy to assess toxic changes Majority had no histologic abnormalities; no hydronephrosis Donin et al. Urology Retrograde single instillation Dosing based on maximum safe volume for swine pelvicalyceal system (7ml) and maximum feasible concentration of Mitogel (8mg/ml) Orders of magnitude higher then required to kill urothelial carcinoma No observed clinical adverse outcomes Histologic evaluation of urinary tract revealed mild abnormalities which diminished with time Urothelial vacuolization, urothelial hypertrophy, erosion and inflammatory infiltrates,, similar to intravesical treatment with MMC No hydronephrosis. Donin et al. Uro Onc
15 MitoGel Future The OLYMPUS study (NC ) is a prospective single-armed phase-3 clinical trial designed to assess the efficacy, safety and tolerability of MitoGel as PRIMARY treatment Once per wk x 6wks, if CR, up to 11 maintenance treatments Inclusion UTUC TaLG, native or recurrent 1 tumour 1.5cm Above UPJO Exclusion Received BCG in past 6mo Hx CIS in urinary tract Invasive UC in urinary tract in past 5 yrs HG in urinary tract in past 2 yrs Current systemic chemo Follow-up with NSS Roupret et al. Euro Urol
16 Follow-up with NSS Canadian guidelines recommend less CTU Kapoor et al. CUAJ Open or Laparoscopic RNU +/- Template LND with removal of distal ureter and bladder cuff is gold standard Open and Laparoscopic techniques have equivalent efficacy and safety in T1-2N0 UTUC Segmental ureteric resection +/- LND with wide margin adequate when feasible and indicated Roupret et al. Euro Urol
17 Lymphadenectomy pn+ is a negative prognostic indicator 5-year CSS of pn0 from 56-85% and 0-39% for pn+ Subgroup analysis reveals staging benefit of LND most substantial with pt2 CSS higher in those with template LND vs No LND, 67% vs 40% respectively; complete template improve CSS on MV analysis LND may aid in durable disease control for pn+ Seisen et al. World J Urol Two Japanese institutions Prospective and non-randomized Standardized LN template irrespective of preoperative staging cn0m0, <75 yo without significant comorbidities 68 template LND vs 66 no template LND Kondo et al. World J Urol
18 Template Lymphadenectomy Left: left hilar and para-aortic Right: right hilar, paracaval, retrocaval and interaortocaval Complications Gr 3 Renal: LND 5.2%, no LND 1.9% Ureteral: LND 2.5%, no LND 0% Kondo et al. Int J Urol Template Lymphadenectomy OS CSS DFS No significant difference in pt stage, grade, and LVI Patients without LND template older and with more MIS 3 yr OS 86.1% template LND vs 48.0% MV analysis LND significant for CSS for pt 2 Complete template had less CSM then incomplete LND No improvement for template when a ureteric tumor Kondo et al. J Urol Kondo et al. Int J Urol
19 Retrospective of prospectively maintained database, RNU or segmental ureterectomy performed at 3 institutions, by 1 surgeon at each institution Anatomic study of N+M0 patients Improved on ureteric tumour lymph node spread Matin et al. J Urol Lymphadenectomy Template Renal pelvis and proximal ureteric tumours Upward migration from mid-distal ureter to paracaval and para-aortic regions Interaortocaval nodes more common R>L Matin et al. J Urol
20 Lymphadenectomy Template Mid ureteric tumours Left retrograde flow Right to left cross-over Matin et al. J Urol Lymphadenectomy Template Distal ureteric tumours Upward migration Matin et al. J Urol
21 Predictors: age, gender, race, symptoms, ECOG PS, tumor side, primary tumor location, tumor architecture, tumor grade, and previous bladder cancer Backward step-down selection process applied to MVA and kept only the most informative variables Margulis et al. J Urol Preoperative Nomogram 76.6% accuracy to predict non-organ confined disease 4 different models in literature, this most generalizable Margulis et al. J Urol Singla et al. Urol Onc
22 US Hydronephrosis Prior cystectomy Sessile BOTH High Grade egfr ct3 Low Neutlymph ratio China Ureter Tumour size Male Singla et al. Urol Onc Renal Function Post-RNU 18-24% decrease in egfr post-rnu >70 yo may be at greater risk of deterioration With threshold of 60ml/min per 1.73m2, 37% eligible for neoadjuvant cisplatin-based chemotherapy and 16% for adjuvant With threshold of 45ml/min ~72% of patients eligible for neoadjuvant chemotherapy based chemotherapy vs 52% Xylinas et al. Urol Onc
23 et al Porten et al RNU all high risk patients offered neoadjuvant chemo + RNU, cn0 High risk: HG, sessile, large Increased LN dissection Age, sessile and NC significant on UVA for OS and/or DSS All T-stages Cisplatin based NC MVAC/DD-MVAC, GC, CGI, IAG 30% received Median 4 cycles Leow et al. Euro Urol Porten et all. Cancer Neoadjuvant Chemotherapy Matin et al 25.4% reduction in pt2 or greater 41.3% reduction in pt3 or greater 14% CR Neoadj chemo OS and DSS and in multivariate analysis, respectively Significant pt down staging, and organ confined disease Matin et al. Cancer Porten et al. Cancer
24 Neoadjuvant Chemotherapy Porten et al. Cancer Intravesical Recurrence Common 27-49% Patient specific factors Male, independent of smoking Previous Bladder Tumour Tumor specific factors Multifocal tumour Large tumour size Preoperative urine cytology positive Ureteric tumor location Preoperative hydronephrosis Treatment specific factors Tumour manipulation during NephroU Preoperative Ureteroscopy Same for manipulation (tumour biopsy, ureteric manipulation) and without manipulation Extravesical excision of distal ureter Lee et al. Clin Genitourin Cancer O Brien et al. Euro Urol Roupret et al. Euro Urol Xylinas et al. Eurourol
25 Survey of Society of Urologic Oncology members, 158/744 participated 50% routinely give intravesical chemotherapy, 15% only with hx UCB 88% MMC 1/3 intraoperatively, 7% 3 POD3, 37% POD 4-7, 20% POD 8-14, and 3% 1/3 routinely used cystogram before instillation MMC intraoperative administration with bladder drainage prior to management of bladder cuff safe Lu et al. Urol Onc Moriarty et al. BMC Urol RCT, multicentre 284 pts with RNU with no history UCB 105 received MMC, 115 observation July Dec 2006 Standard post-op care or single dose 40mg/40ml MMC immediate prior to catheter removal Recurrence examined by cystoscopy 3, 6 and 12 mo post-op, histology not required More HG in MMC arm Recurrence more common with moderately and poorly differentiated tumours O Brien et al. Euro Urol
26 Intravesical Adjuvant MMC 40% relative risk reduction and 11% absolute risk reduction of intravesical recurrence NNT 9 p0.055 No standardized timing of catheter removal O Brien et al. Eur Urol RCT, multicentre 77 patients underwent RNU Dec 2005 Nov 2008 Standard post-op care or single dose 30mg/30ml Pirarubicin (THP) within 48 hours post-rnu Analog of Doxirubicin, ideal dwell time 30 mins Recurrence examined by cytology and cystoscopy 3mo for 2 years Ito et al. JCO
27 Intravesical Adjuvant THP 1 and 2 year recurrence rate 16.9% and 16.9% in THP group vs 31.8% and 42.2% Immediate bladder symptoms with instillation not reported Post RNU no hematologic or biochemical changes identified Ito et al. JCO Prognostic Factors Post-op Tumour stage Extra-nodal extension Tumour grade LVI Surgical margins Extensive tumour necrosis Sessile Architecture Smoking Ureteral Multifocal ASA score Obesity Pre-treatment neutrophillymphocyte Molecular markers Roupret et al. Euro Urol
28 Retrospective, multi-institutional, and tertiary care 2233 patients with pt1-3/n0-x 63.6% pt2-3, 68.6% Nx Chemotherapy naive Accuracy 0.81 (95% CI, ) MVA variables of statistical significance Age, pt2-3, ureter, multifocal, LVI, tumour archetype sessile and concomitant CIS T stage most important for CSS Seisen et al. BJUI Prognostic Factors Post-op Seisen et al. BJUI
29 Japan, 14 centres, 873 patients, 129 received adjuvant chemotherapy High risk patients included for adjuvant chemotherapy review Adjuvant chemotherapy MVAC, GC or other if renal insufficiency or older age MVAC avg 2.4 cycles and GC avg 2.2 cycles Shirotake et al. J Urol Systemic Recurrence Shirotake et al. J Urol
30 Systemic Recurrence 4 pathologic indicators of CSS used to create 3 risk groups Grade, Stage (>pt2) LVI, and LN Low: 0 Intermediate: 1-2 High: >3 Shirotake et al. J Urol Systemic Recurrence Shirotake et al. J Urol
31 Adjuvant Chemotherapy Shirotake et al. J Urol Systemic Adjuvant Chemo Retrospective, National Cancer Database of 3,253 patients 762 patients pt3/4 and/or pn+ received adjuvant chemotherapy, 2491 received observation Unclear which adjuvant chemotherapy regimens used, excluded single agent and >90 days RNU Median time to chemotherapy 47 days MVA indicated patients age <75, ureteric location, any ptanyn+, and surgical margin +ve increased odds of receiving AC Inverse probability of treatment weighting (IPTW) analysis used to account for selection bias and observed differences in baseline characteristics After all standardized differences <10% = negligible 31
32 Adjuvant Chemotherapy Seisen et al. J Clin Onc year IPTW adjusted KM curve median OS mo with AC vs mo 12 month OS benefit 5 year IPTW adjusted OS 43.9% with AC vs 35.85% Treatment effect less pronounced in pt3/t4nx versus pt3/t4n0 and pt4anyn+ Only 20.74% of pt3/t4nx received AC (versus 22.39% and 45.09% for pt3/t4n0 and ptanyn+) May be related to care providers being more reluctant to administer care to these individuals Adjuvant Chemotherapy Seisen et al. J Clin Onc
33 Adjuvant Chemotherapy Age, gender, Charlston comorbidity index, pathologic stage and surgical margin status did not impact AC treatment effect Seisen et al. J Clin Onc Adjuvant Chemotherapy Necchi et al. BJUI Retrospective, 15 centres in Europe and USA 1544 patients, 312 receiving adjuvant chemotherapy High risk disease defined as >pt2 and/or N+ Inclusion chemotherapy started <90 days, no comment on which therapy and if single agent included Also used IPTW though standardized differences 20-50%; required doubly robust estimation AND primary analysis method Statistical analysis found likely confounders that remained unaccounted for, FOR ALL study endpoints NO survival benefit found 33
34 Summary Accurate staging is becoming ever more important in UTUC New staging and NSS techniques developing Prognostic modalities pre and post-op should be used to shape treatment NSS vs MIS vs open Template LND, suspicion of pt>2 Neoadjuvant vs adjuvant chemotherapy Intra-operative intravesical therapy at time of RNU, before bladder cuff management, has been shown safe and likely has highest efficacy Upper tract delivery of MMC should be considered more frequently Future Questions Should patient s with Lynch Syndrome be screened for UTUC? Best diagnostic test(s) with problem regarding accurate staging? Most effective nephron sparing surgical techniques +/- adjuvant upper tract chemotherapy? Studies investigating best intravesical agent, including timing? Role of neoadjuvant chemotherapy, template LND, and adjuvant chemotherapy? 34
35 Special Thanks Dr. Black Dr. Chew 12 months 24 months Yuan et al. J Chemother
36 Prognostic Genetic Signature DNA copy number aberrations occur more frequently with LVI ERBB2 gene amp associated with HER2 protein overexpression and HG disease HER2 early predictor of intravesicular recur Micosatelite instability Hallmark of Lynch Syndrome 46% UTUC, high MSI indicates better prognosis predicted benefit from Pembro in CRC Unfavorable cell cycle regulators and proliferation marker risk score associated with advanced pt, NOCD, LVI, and inf Ca spec survival Essential proteins significantly secreted in urine are possible biomarker for UTUC Increased pathway of tumor genesis understanding leading to increasing targetable therapies FGFR3, CDKN2B, TSC1, and PIK3CA Li et al. Curr Urol Rep Antegrade MitoGel Donin et al. Urology
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