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Purpose <p>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 &lt; 2&#xa0;cm. Most evidence derives from retrospective registries, whereas prospective data remain limited.</p> Methods <p>This multi-center, prospective, non-randomized clinical trial was conducted in five European centers between January 2015 and July 2021. Seventy-six patients aged &gt; 50&#xa0;years with asymptomatic, unilateral SRM &lt; 2&#xa0;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).</p> Results <p>69 patients were included in the analyses<b>.</b> After a median follow-up of 88&#xa0;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) (&lt; 12&#xa0;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.</p> Conclusion <p>Long-term follow-up confirms AS as the standard initial option for selected patients with SRMs ≤ 2&#xa0;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.</p>

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Active surveillance for renal masses up to 2 cm: long-term oncological outcomes from a prospective multi-institutional study

  • 期刊论文

  • 发表日期：

    2026年4月28日

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  • Chiara Re,
  • Alessandro Bertini,
  • Pietro Scilipoti,
  • Tommaso Saccucci,
  • Guglielmo Mantica,
  • Walter Cazzaniga,
  • Rayan Matloob,
  • Giario Conti,
  • Carmen Maccagnano,
  • Maria Furlan,
  • Nazareno Suardi,
  • Claudio Simeone,
  • Emanuele Montanari,
  • Giancarlo Albo,
  • Silvia Stagni,
  • Roberto Salvioni,
  • Fabio Castiglione,
  • Alessandro Larcher,
  • Giuseppe Rosiello,
  • Carlo Terrone,
  • Francesco Montorsi,
  • Andrea Salonia,
  • Umberto Capitanio,
  • Roberto Bertini

摘要

Purpose

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.

Methods

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).

Results

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.

Conclusion

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.