Active surveillance for renal masses up to 2 cm: long-term oncological outcomes from a prospective multi-institutional study.
The widespread use of cross-sectional imaging has increased the incidental detection of small renal masses (SRMs). In this context, overtreatment represents a major concern, particularly for lesions < 2 cm. Most evidence derives from retrospective registries, whereas prospective data remain limited.
This multi-center, prospective, non-randomized clinical trial was conducted in five European centers between January 2015 and July 2021. Seventy-six patients aged > 50 years with asymptomatic, unilateral SRM < 2 cm were enrolled and followed under a structured prospective active surveillance (AS) protocol with periodic axial imaging. Active treatment was recommended according to predefined progression criteria or patient preference. The primary endpoint was event-free survival (EFS); secondary endpoints included treatment-free survival (TFS), overall survival (OS), and cancer-specific mortality (CSM).
69 patients were included in the analyses. After a median follow-up of 88 months, 8-year EFS and TFS were 66% and 83%, respectively. 17% of patients required active treatment, mainly due to tumor growth. The 8-year OS and CSM were 88% and 9.6%. One patient died of metastatic RCC. Shorter tumor doubling time (DT) (< 12 years) and high RENAL score were significantly associated with higher risks of event and treatment. Endophytic tumors, and higher PADUA score also predicted adverse outcomes.
Long-term follow-up confirms AS as the standard initial option for selected patients with SRMs ≤ 2 cm, with a low rate of progression and optimal survival rates. Tumor DT and mass location should be considered in clinical decision-making to identify patients who will deserve a deferred treatment in case of progression.
This multi-center, prospective, non-randomized clinical trial was conducted in five European centers between January 2015 and July 2021. Seventy-six patients aged > 50 years with asymptomatic, unilateral SRM < 2 cm were enrolled and followed under a structured prospective active surveillance (AS) protocol with periodic axial imaging. Active treatment was recommended according to predefined progression criteria or patient preference. The primary endpoint was event-free survival (EFS); secondary endpoints included treatment-free survival (TFS), overall survival (OS), and cancer-specific mortality (CSM).
69 patients were included in the analyses. After a median follow-up of 88 months, 8-year EFS and TFS were 66% and 83%, respectively. 17% of patients required active treatment, mainly due to tumor growth. The 8-year OS and CSM were 88% and 9.6%. One patient died of metastatic RCC. Shorter tumor doubling time (DT) (< 12 years) and high RENAL score were significantly associated with higher risks of event and treatment. Endophytic tumors, and higher PADUA score also predicted adverse outcomes.
Long-term follow-up confirms AS as the standard initial option for selected patients with SRMs ≤ 2 cm, with a low rate of progression and optimal survival rates. Tumor DT and mass location should be considered in clinical decision-making to identify patients who will deserve a deferred treatment in case of progression.
Authors
Re Re, Bertini Bertini, Scilipoti Scilipoti, Saccucci Saccucci, Mantica Mantica, Cazzaniga Cazzaniga, Matloob Matloob, Conti Conti, Maccagnano Maccagnano, Furlan Furlan, Suardi Suardi, Simeone Simeone, Montanari Montanari, Albo Albo, Stagni Stagni, Salvioni Salvioni, Castiglione Castiglione, Larcher Larcher, Rosiello Rosiello, Terrone Terrone, Montorsi Montorsi, Salonia Salonia, Capitanio Capitanio, Bertini Bertini
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