In this abstract, the authors from an Italian multi-center study present their results (to-date) from a prospective non-randomized observational study of patients with renal masses ≤2 cm who are placed on AS – initiated in April 2014. From the authors, every patient with a small renal mass is now offered AS up front – however, the presenting author made it very clear that most opt for treatment and are not included in today’s presentation. His estimation is ~10-20% opted for enrollment on AS.
For this trial, they only enrolled patients with unilateral SRM (≤2cm of diameters), who were older than 50 years of age and were asymptomatic. Patients with a previous history of renal cancer, solitary kidney, hereditary tumors, presence of metastasis, immunosuppressant therapy or with a life expectancy less than 1 year were considered ineligible. All patients, after enrollment, underwent a standardized follow-up scheme, which also included a collection of urine and blood samples for the creation of a biobank.
To-date, 59 patients have been enrolled over a 5 year period, highlighting the relatively low adoption rate. Of these, 2/59 (3.4%) have dropped out of the study, but none have died during the study period. The mean follow-up time was 24.7 months (SD 8.6).
Basic demographics are below:
- Predominantly male, aged 65-84, ECOG 0
- Included 3 cystic renal masses (5%)
The mean annual increase in the linear growth has been 0.13cm/year and the mean annual increase in the volumetric growth has been 0.71cm3/year. These are consistent with prior reports.
During follow-up, as mentioned above, no patients died. During that time, no patients have developed symptoms or paraneoplastic syndromes as well.
- 3/59 (5%) have been submitted to percutaneous biopsy due to tumor growth (2 RCC treated with thermal ablation and 1 angiomyolipoma, not treated)
- 2/59 (3.4%) patients elected for partial nephrectomy.
This is an encouraging start for this consortium’s active surveillance experience and we look forward to seeing more data in the future.
Presented by: Walter Cazzaniga, Urological Research Institute, IRCCS, Milan, Italy
Written by: Thenappan Chandrasekar, MD, Clinical Instructor, Thomas Jefferson University, @tchandra_uromd, @JEFFUrology, at the 34th European Association of Urology (EAU 2019) #EAU19, conference in Barcelona, Spain, March 15-19, 2019.