Larger trial to compare approaches for small renal masses appears feasible, safe
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A small trial that compared radiofrequency ablation with stereotactic body radiation therapy for small renal masses resulted in minimal adverse events, according to results presented at International Kidney Cancer Symposium.
Investigators intend to launch a larger multicenter trial comparing these approaches.
Partial nephrectomy is standard for definitive management of small renal masses, defined as those 4 cm or smaller.
However, ablative technologies offer an alternative to surgery. Prior studies showed cancer-specific survival between 95% and 100% for both radiofrequency ablation and partial nephrectomy for pT1a stage disease.
Stereotactic body radiation therapy — which is locally effective and associated with low rates of toxicity — is an emerging treatment option for nonsurgical management of small renal masses. However, no high-level evidence exists comparing stereotactic body radiation therapy with radiofrequency ablation, according to study background.
Anil Kapoor, MD, professor of urology and director of research in the division of urology at St. Joseph’s Healthcare in Ontario, and colleagues conducted a prospective randomized parallel-controlled trial to determine the safety and toxicity of radiofrequency ablation vs. stereotactic body radiation therapy for small renal masses.
Investigators recruited 24 patients (median age, 67 years; men, n = 17; white, n = 23) between January 2020 and July 2021.
All patients had biopsy-confirmed renal cell carcinoma and were scheduled for treatment of small renal masses at a single academic tertiary center. Most patients had clear cell renal cell carcinoma (n = 17).
Researchers randomly assigned 13 patients to radiofrequency ablation and 11 patients to stereotactic body radiation therapy.
Radiofrequency ablation — performed percutaneously — consisted of two 8-minute cycles in a single session, with average ablative temperatures of 105°C.
Stereotactic body radiation therapy to the primary kidney lesion consisted of 25 Gy in one fraction.
Study protocol included biopsy at baseline; imaging and follow-up at 3, 6 and 9 months after the assigned procedure; and biopsy and imaging at 12 months.
Feasibility endpoints included safety, as well as recruitment, consent and completion rates. Clinical endpoints included DFS, quality of life and renal toxicity.
At data cutoff, eight patients had received radiofrequency ablation and 11 had received stereotactic body radiation therapy.
Among patients assigned stereotactic body radiation therapy, one experienced a grade 2 pain flare-up. Two underwent 12-month biopsy that showed no residual tumor.
Two patients — one in each treatment group — had repeat imaging at 9 months that showed no evidence of recurrence or metastatic disease.
“Results have shown good oncological control at follow-up biopsy and imaging,” Kapoor and colleagues wrote.
The findings show a larger prospective, randomized trial to compare these approaches is feasible and safe, they concluded.
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Kapoor A, et al. Abstract CTR13. Presented at: International Kidney Cancer Symposium; Nov. 5-6, 2021; Austin, Texas.
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