On Day 2 of EMUC24, urologist Prof. Axel Bex (GB), radiotherapist Dr. Constantinos Zamboglou (DE), and medical oncologist Prof. Yüksel Ürün (TR) chaired the first ever EMUC Plenary Session designed by the Kidney Cancer Association (KCA). The session was developed to address the most pressing issues in current practices and the future direction of kidney cancer treatment. The presentations included several practice-changing papers and a debate on the evidence for local tumour control in metastatic RCC.
FASTRACK II
“Surgery is the standard of care for primary RCC, however older patients might have co-morbidities that may exclude them from this option,” stated radiotherapist Dr. Anna Bruynzeel (NL) in her presentation on the methodology and results of the non-randomised FASTRACK II trial (Focal Ablation Stereotactic Radiotherapy for Cancers of the Kidney). “The aim of the study was to investigate the efficacy of SABR as a treatment option for renal cancer patients who are unwilling or unfit to undergo surgery. This group of RCC patients who are medically inoperable with larger tumours, have limited curative treatment options and need an effective alternative.”
According to Dr. Bruynzeel, SABR is a precise, high-dose radiation treatment targeting tumours with minimal impact on surrounding tissue and the FASTRACK I study concluded this method for primary RCC was feasible and well tolerated. “These findings have been used for the design on this next phase 2 trial.”
Dr. Bruynzeel on the study results: “The medium follow-up was 43 months. For the primary endpoint assessment, local control at 12 months from start of treatment was 100%. There were no local failures observed during the trial. Freedom from distant failure was 97%. Cancer specific survival was also 100%. Overall survival was 99% at 12 months, and 82% at 36 months from the start of treatment.”
“The excellent oncological outcomes after SABR for primary RCC observed in this trial are concordant with those reported in the prospective and retrospective literature. SABR can be considered a proven modality in this group of patients with larger tumours.”
According to Dr. Bruynzeel, the next step is now randomised trial surgery versus SABR. She also concluded her presentation with some remarks to consider: “In comparison to prospective trials of surgery, FASTRACK II has a smaller sample size and less mature follow-up. The study did not have a control group, so it was not possible to access whether SABR is superior, inferior, or similar to other treatment options. Definitions of operability or technically high risk might vary between multidisciplinary teams.”
KEYNOTE 564 OS
Urologist Prof. Jens Bedke (DE) shared the study design and results of KEYNOTE-564 OS that was presented earlier this year at ASCO GU 2024, that indicated this phase 3 trial showed improved overall survival with an adjuvant therapy among patients with clear-cell-renal carcinoma who were at risk of disease reoccurrence after nephrectomy. In his summary, Prof. Bedke stated that pembrolizumab is the first adjuvant treatment in RCC with an improvement in overall survival (OS). In his opinion, there is risk of overtreatment and risk of life-long treatment related adverse events (e.g. life-long toxicities, and life-long L-Thyroxin). “Failure of CheckMate 914, Immotion010 and PROSPER with drugs active in the metastatic setting (nivolumab plus ipilimumab, nivolumab and atezolizumab) raises questions about patient selection and conduct of trials. Better selection criteria using a hybrid of pathological risk, somatic driver mutations and molecular subtypes are required beyond PD-L1 and sarcomatoid features and dosage. New therapy approaches such as mRNA vaccination plus ICI trials are recruiting.”
You can watch a webcast recording of the full RCC Plenary Session on the EMUC24 Resource Centre.
