Current Experience with Intrapelvic/Intraureteral Irrigation/Ablative Therapy
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1 Current Experience with Intrapelvic/Intraureteral Irrigation/Ablative Therapy Seth P. Lerner, MD, FACS Beth and Dave Swalm Chair in Urologic Oncology Scott Department of Urology Baylor College of Medicine FOIU, 2016
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3 Disclosures Clinical trials Endo, FKD, Roche/Genentech, Viventia Advisory Board Ferring, Nucleix, OncoGeneX, Sitka, Taris Consultant Biocancell, Telesta, UroGen, Vaxiion
4 UTT Intracavitary Therapy First endoscopic treatment reported Delivery vie percutaneous nephrostomy or via ureteral catheter MMC, Epirubicin, Thiotepa, BCG, BCG/IFN 2 1 Huffman, et al Cancer 55:1422, Audenet, et al World J Urol 31:45, 2013
5 UTT Intracavitary Therapy EAU guidelines (2015) Antegrade instillation of BCG or MMC after complete tumour eradication is feasible as adjuvant tx or for conservative tx of CIS (LE: 3) Retrograde instillation via ureteral catheter can be dangerous due to possible ureteric obstruction and pyelovenous influx during instillation/perfusion. Reflux via double-j stent not advisable since it often does not reach the renal pelvis. Japanese study (Tokyo strain) - 9/9 patients with high grade positive cytology converted to negative mean duration 86 days (53-264) 1 1 Irie, et al Urology 59:53, 2002
6 Upper Tract Irrigation Verify sterile urine Micro/mini drip chamber; 50cc volume; run in over hour Use manometer to keep intrapelvic pressure 20cm water
7 Retrograde SP Catheter Place x-tra long guide wire to upper tract Fill bladder through cystoscope Percutaneous cystostomy w/ 18 ga needle Pass 2nd guide wire through sp site Grasp 2nd wire and deliver antegrade per urethra Patel, et al J Urol 159: 71, 1998
8 Retrograde SP Catheter Dilate SP site to 10 Fr. w/ 8/10 coaxial dilator Leave 8 Fr. introducer externalized per urethra Pass x-tra long wire into 8 Fr. and pull into bladder Patel, et al J Urol 159: 71, 1998
9 Retrograde SP Catheter J-wire 5 Fr. Pollack into upper tract Exchange x-tra long wire w/ super stiff Pass single j stent over super stiff under fluoro into upper tract Remove guide wire, cap stent, suture stent in place Patel, et al J Urol 159: 71, 1998
10 UTT Intracavitary Therapy p = p = patients treated with BCG via PCN 64 kidneys; 42 with CIS Less effective as adjuvant therapy 1 Giannarini, et al Eur Urol: 60:955, 2011
11 UTT Intracavitary Therapy Review of 12 series upper tract instillation Post resection Ta/T1 adjuvant therapy N = 22 (renal units-ru) MMC recurrence 14-29% ( mos) N = 202 (ru); BCG recurrence 11-87% ( mos) Largest series (50 ru) BCG 36% recurrence at 61 mos Curative therapy for CIS using BCG N = 176 (ru) RR %; Recurrence 0-55% (1-82 mos) Largest series 42 (ru) 40% recurrence (42 mos) Audenet, et al World J Urol 31:45, 2013
12 Single Dose Peri-operative MMC Prospective n=19 patients (one bilateral) Exclusion: known HG cancer; tumor > 1.5cm; incomplete laser ablation (majority LG) 5F open ended catheter MMC 40mg/40cc NS over 40 minutes; clamped + 20 minutes 13 cancer free long term (24 months) 7 repeat ablation and MMC mean 4 months No systemic toxicity 3 ureter strictures Aboumarzouk, et al Urol Annals 5:3, 184
13 UTT Intracavitary Therapy Marker lesion trial standard of care for testing activity of new drugs for intravesical therapy 23 studies with >1200 patients CR in 30% to 50%; highest response rate Apaziquone (67%); CR higher RFS No progression in intermediate risk patients Chemoablation of upper tract tumors? Gofrit, et al J Urol 183: , 2010
14 MitoGel TM - Chemistry Poloxamer 407 based inverse thermosensitivity Block co-polymer PEO-PPO-PEO Also acts as surfactant MMC 4mg/1ml gel 20 cc gel = 80mg MMC Solid at body temperature Liquid at low temperature
15 MitoGel Pre-Clinical (swine model) studies results show: Dwell time of >6h were shown No occlusion / blockages No renal function impairment PK plasma within safety limits T0 T2 T4 T6 T8 The gel filled the renal cavity and ureter and dissolves slowly in few hours Chamie et al AUA
16 Injector Syringe filled with Mitogel Syringe Housing 16
17 MitoGel: Clinical Proof of Concept in UTUC: Chemoablation for Organ Sparing Pre Post Ongoing UTUC Compassionate Use Program 18 patients enrolled United States (MD Anderson, Baylor College), Netherlands, Switzerland; Israel Localized treatment of hard to resect tumors; extensive tumor burden 12 with confirmed low-grade disease 10 evaluated to date >90 instillations performed Feasibility and safety demonstrated Complete response* Partial response Evaluated to date** * Durability evaluations ongoing (as of June 2016) Images courtesy of Dr. Gregory Wirth, Geneva Hospital, Switzerland ** Reached primary evaluation time
18 BCM Patient 2 73 yo male Prior left nx for AML Long history of recurrent TaLG right renal pelvis dating to 2007 Bladder TaLG progressed to CIS Rx BCG Intracavitary MMC, BCG Most recent ureteroscopy minimal disease Completed 6/6 Mitogel 6mg/cc Follow up ureteroscopy necrotic tumor No viable cancer
19 UTT - Study Outline Treatment: Six (6) once weekly instillations of MitoGel Preparation. MMC dosage: 4mg per 1mL of TC-3 gel Based on renal pelvis and calyx volume (5-15mL) 20-60mg MMC total dose 1.3gm NaHCO3 HS, AM and 30 prior to tx Target Patient Population: 74 patients with Pathologically confirmed LG non-invasive UTUC 90% power to demonstrate that the observed CR rate is superior to the rate of 15%. 19
20 UTT - Study Outline Study Design: A prospective Phase 3, open label, single arm trial, in patients with LG UTUC 1-3 Weeks 6 Weeks 3 ± 1 Weeks 12 Months Product: Baseline M 6 FU1 Mitogel kit (0.4% MMC; hydrogel) M 9 FU2 M 12 FU3 Study Objectives: Efficacy and safety of Mitogel instillation in the treatment of UTUC 20
21 Summary Intracavitary (renal pelvis) treatment with BCG or MMC safe and minimal toxicity Deliverable via PCN, ureteral catheter, suprapubic ureteral catheter Monitor intrepelvic pressures 20cm water Reverse thermosensitive polymers facilitate 4-6 hours exposure with MMC Compassionate use in the upper urinary tract demonstrates feasibility and safety Phase III trial planned for 2016
22 Research Team Pre-Clinical Karim Chamie Alan Pantuck Clinical Trial Mark Schoenberg Surena Matin Karim Chamie Alan Pantuck UroGen Gil Hakim Nadav Malchi Ifat Klein Avi Gordon Dalit Strauss Yael Agmon Neely Ivgy-May Michal Jeshurun
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