Page 9 - CUA2019 Abstracts - Oncology-Kidney

2019 CUA AbstrACts

Podium Session 4: Mixed Oncology

July 1, 2019; 0910–1010

POD-4.1 1 Department of Urologic Sciences, University of British Columbia,
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TLD-1433 photodynamic therapy for Bacillus Calmette-Guerin- Vancouver, BC, Canada; Western Health, Melbourne, Australia;
unresponsive non-muscle-invasive bladder cancer: A phase 1b 3 Department of Genitourinary Oncology, H Lee Moffitt Cancer Center
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clinical study and Research Institute, Tampa FL, United States; University of Auckland,
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Girish S. Kulkarni , Lothar D. Lilge , Arkady Mandel , Roger White , Nathan Auckland, New Zealand; University of Alberta, Edmonton, AB, Canada;
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Perlis , Michael Nesbitt , Michael A. Jewett 1 6 Department of Urology, The Netherlands Cancer Institute - Antoni van
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1 Surgery and Surgical Oncology, University of Toronto, Toronto, ON, Leeuwenhoek Hospital, Amsterdam, The Netherlands; Department
Canada; Medical Biophysics, University of Toronto, Toronto, ON, Canada; of Urology, MD Anderson Cancer Center, Houston, TX, United States;
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3 Research and Product Development, Theralase Inc., Toronto, ON, Canada 8 Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland,
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Introduction: TLD-1433 is a ruthenium-based photodynamic compound OH, United States; Department of Urology, Fundacion Instituto Valenciano
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that demonstrates preferential uptake into bladder cancer cells. Upon expo- de Oncologia, Valencia, Spain; Department of Urology, University of
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sure to green light (525 nm), TLD-1433 is activated to release free radicals Texas Southwestern Medical Center, Dallas, TX, United States; Department
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that cause cell death. Our aim was to assess the safety, tolerability, phar- of Urology, University of Münster, Münster, Germany; Department of
macokinetics, and exploratory efficacy of TLD-1433 photodynamic therapy Urology, University of Oklahoma College of Medicine, Oklahoma City,
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(PDT) in non-muscle-invasive bladder cancer (NMIBC) Bacillus Calmette- OK, United States; Department of Urology, The James Buchanan Brady
Guerin (BCG)-unresponsive patients. Urological Institute, The Johns Hopkins School of Medicine, Baltimore,
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Methods: TLD-1433 was instilled intravesically in the preoperative holding MD, United States; Department of Urology, University of Kansas Medical
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area for one hour. Upon induction of general anesthesia, drug activation was Center, Kansas City, KS, United States; Department of Urology, University
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performed using a 525 nm, 3 W laser with a target dose of 90 J/cm . A 3+3 of Michigan Health System, Ann Arbor, MI, United States; Hertfordshire
dose escalation strategy, starting with the maximum recommended starting and Bedfordshire Urological Cancer Centre, Department of Urology,
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dose (MRSD) of 0.35 mg/cm with an increase to the planned therapeutic Lister Hospital, Stevenage, United Kingdom; Department of Urology,
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dose of 0.70 mg/cm was followed. Safety, tolerability, and pharmacokinet- Freeman Hospital, Newcastle Upon Tyne, United Kingdom; Department
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ics were reviewed by an independent data safety and monitoring board. of Medicine, Division of Oncology, University of Washington School of
Patients underwent cystoscopy at three and six months post-treatment to Medicine and Fred Hutchinson Cancer Research Center, Seattle, WA,
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assess efficacy, defined as recurrence-free survival. United States; Department of Urology, Weill Cornell Medical College,
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Results: Three patients were treated at the MRSD (0.35). At 30 days post- Presbyterian Hospital, New York, NY, United States; Department of
treatment, all patients tolerated the procedure well with no grade 3, 4, or Urology, Cochin Hospital, APHP, Paris Descartes University, Paris, France;
5 adverse events (AEs). Pharmacokinetic analysis demonstrated minimal 21 Department of Surgery, Exeter Surgical Health Services Research Unit,
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systemic absorption of drug with no photosensitivity reactions. All drug Royal Devon and Exeter NHS Trust, Exeter, United Kingdom; Department
was cleared from the plasma within 72 hours of activation. Three patients of Surgery (Division of Urology), McGill University Health Centre,
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were then treated at the therapeutic dose (0.70) with no grade 3, 4, or 5 Montréal, QC, Canada; Department of Urology, University of California
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AEs and an identical pharmacokinetic profile to half-dose. At half-dose, at Davis, Davis Medical Center, Sacramento, CA, United States; Princess
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all patients had developed recurrent, but not progressive, NMIBC by the Margaret Hospital, Toronto, ON, Canada; Bristol Urological Institute,
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180-day cystoscopy. At therapeutic dose, two of three patients were tumour- North Bristol NHS Trust, Bristol, United Kingdom; Department of Urology,
free at the 180-day cystoscopy. Moderate bladder irritability was reported Medical University of Vienna, Vienna General Hospital, Vienna, Austria;
at full-dose that mostly resolved within 90 days. 27 Department of Urology, University of Washington, Seattle, WA, United
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Conclusions: TLD-1433 PDT is safe and tolerable at the therapeutic dose. States; Cross Cancer Institute, Edmonton, AB, Canada; Department
The efficacy signal at 180 days post-treatment warrants further study in a of Urologic Surgery, Vanderbilt University Medical Center, Nashville,
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phase 2 trial. TN, United States; Department of Hematology and Medical Oncology,
Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, United States;
31 Department of Urology, Stanford University School of Medicine, Stanford,
POD-4.2 CA, United States; USC/Norris Comprehensive Cancer Center, Institute of
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The prognostic value of the neutrophil-to-lymphocyte ratio Urology, University of Southern California, CA, United States
in patients with muscle-invasive bladder cancer treated with Introduction: The neutrophil-to-lymphocyte ratio (NLR) is an attractive
neoadjuvant chemotherapy and radical cystectomy marker because it is derived from routine bloodwork. NLR has shown
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Anna Black , Homayoun Zargar , Kamran Zargar-Shoshtari , Adrian S. promise as a prognostic factor in muscle-invasive bladder cancer (MIBC),
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Fairey , Laura S. Mertens , Colin P. Dinney , Maria C. Mir , Laura-Maria but its value in patients receiving neoadjuvant chemotherapy (NAC) before
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Krabbe 10,11 , Michael S. Cookson , Niels-Erik Jacobsen , Nilay Gandhi , radical cystectomy (RC) is not yet established. Since NLR is related to an
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Joshua Griffin , Jeffrey S. Montgomery , Nikhil Vasdev 16,17 , Evan Y. Yu , oncogenic environment and poor anti-tumour host response, we hypoth-
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Evanguelos Xylinas 19,20 , Nicholas J. Campain , Wassim Kassouf , Marc A. esized that a high NLR would be associated with a poor response to NAC
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Dall’Era , Jo-An Seah , Cesar E. Ercole , Simon Horenblas , John S. McGrath , and would remain a poor prognostic indicator in patients receiving NAC.
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Jonathan Aning 21,25 , Shahrokh F. Shariat 19,26 , Jonathan L. Wright , Andrew C. Methods: A retrospective analysis was performed on patients with non-
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Thorpe , Todd M. Morgan , Jeff M. Holzbeierlein , Trinity J. Bivalacqua , metastatic MIBC who received NAC prior to RC between 2000 and 2013
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Scott North , Daniel A. Barocas , Yair Lotan , Petros Grivas 18,30 , Andrew J. at one of 19 centres across Europe and North America. The pre-NAC NLR
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Stephenson , Jay B. Shah 7,31 , Bas W. van Rhijn , Philippe E. Spiess , Siamak was used to split patients into a low (NLR ≤3) and high (NLR >3) group.
Daneshmand , Srikala S Sridhar , Peter C. Black 1 Demographic and clinical parameters were compared between the groups
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S154 CUAJ • June 2019 • Volume 13, Issue 6(Suppl5)
© 2019 Canadian Urological Association