EAU 2019: Active Surveillance for Small Renal Masses ≤2cm: Results from an Italian Multi-Institutional Prospective Protocol

Barcelona, Spain (UroToday.com) Active surveillance (AS) for small renal masses has become an established first-line treatment option based on growing evidence of the indolent natural history of the majority of these lesions. Yet, the uptake for AS has been quite low. In general, however, most physicians agree that AS is ideal for an elderly patient with multiple comorbidities, where the competing risks outweigh treatment benefit.

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:

EAU2019_demographic_characteristics.png

  • Predominantly male, aged 65-84, ECOG 0
  • Included 3 cystic renal masses (5%)
At the enrollment, the mean linear diameter was 1.3 cm (SD 0.36) and the mean volume was 1.8 cm3 (SD 1.22). The tumor characteristics are below:

EAU2019_renal_masses_characteristics.png

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. 
Overall, 4/59 (6.8%) patients have progressed to active treatment due to tumor growth or election for intervention.

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.