(UroToday.com) The 2025 AUA annual meeting featured a kidney cancer session and a presentation by Dr. Pratik Kanabur discussing a cost-effectiveness analysis of 89Zr-girentuximab PET-CT (TLX250) to guide management of small renal masses. With the limitations of conventional imaging and biopsy, accurate and non-invasive techniques to characterize small renal masses remain an unmet need. The ZIRCON trial demonstrated that TLX250 PET/CT scans aid in small renal masses characterization.1
ZIRCON was an open-label, multicenter clinical trial, recruiting patients with an indeterminate renal mass (≤ 7 cm; tumor stage cT1) who were scheduled for partial nephrectomy within 90 days of planned TLX250 administration. Enrolled patients received a single dose of TLX250 IV (37 MBq ± 10%; 10 mg girentuximab) on Day 0 and underwent PET/CT imaging on Day 5 (± 2 days) prior to surgery. Of 284 evaluable patients included in primary analysis, the average across all 3 readers for sensitivity and specificity was 86% (95% CI 80%, 90%) and 87% (95% CI 79%, 92%), respectively, for co-primary endpoints, and 85% (95% CI 77%, 91%) and 90% (95% CI 79%, 95%), respectively, for key secondary endpoints. For all readers, the lower boundaries of 95% CI for co-primary and key secondary endpoints were > 75%. For all evaluable patients, positive and negative predictive values were ≥ 91.7% and ≥ 73.7%, respectively. At the 2025 AUA annual meeting, Dr. Kanabur presented results evaluating the clinical and economic value of TLX250 to guide small renal mass management.
Dr. Kanabur and colleagues developed a decision analytic Markov model to estimate the costs and health outcomes of managing a healthy 65-year old patient with an asymptomatic small renal mass using competing strategies, including:
- Reference arm: Empiric partial nephrectomy
- Option 1: Renal mass biopsy
- Option 2: TLX250 PET–CT
- Option 3: TLX250 followed by biopsy to confirm negative PET/CT
They assessed lifetime health utilities, measured in quality adjusted life-years, and direct medical costs from the perspective of health care payers in the United States. They also calculated the incremental cost-effectiveness ratio for the three options compared to the reference arm, with a willingness to pay threshold of $100,000/quality adjusted life-years. Probabilistic sensitivity analysis was performed.
Among options 1-3, option 3 had the lowest risk of untreated malignant tumors (1.0% versus 2.1% for option 1, 16.5% for option 2, and 0% for empiric partial nephrectomy) and the highest probability of leaving benign tumors untreated (82.9% versus 53.8% for option 1, 50.7% for option 2, and 0% for empiric partial nephrectomy). In base case analysis, option 3 was the most cost-effective strategy. It dominated empiric partial nephrectomy and option 2 and had an incremental cost-effectiveness ratio of $35,757 versus option 1:
In probabilistic sensitivity analysis, option 2 had the highest probability of being the most cost-effective strategy across a wide range of commonly accepted willingness to pay thresholds:
Dr. Kanabur concluded his presentation discussing a cost-effectiveness analysis of TLX250 to guide management of small renal masses with the following take home points:
- The use of TLX250 alone is the most cost-effective strategy across a range of costs and probabilities
- TLX250 with reflex renal mass biopsy for negative scans helps avoid unnecessary treatment of benign small renal masses and minimizes risks of untreated malignant small renal masses, and can be cost effective compared to renal mass biopsy and empiric partial nephrectomy
Presented by: Pratik Kanabur, MD, University of California – Los Angeles, Los Angeles, CA
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 American Urological Association (AUA) annual meeting held in Las Vegas, NV, Saturday, April 26 - Tuesday, April 29, 2025
Related content: Cost-Effectiveness of 89Zr-DFO-Girentuximab PET Scan for Small Renal Mass Diagnosis - Pratik Kanabur
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Related Content:Cost-Effectiveness of 89Zr-DFO-Girentuximab PET Scan for Small Renal Mass Diagnosis - Pratik Kanabur