Clinical Outcomes in Clinical N0 (cN0) Squamous Cell Carcinoma (SCC) of the Penis according to Nodal Management: Early, Delayed or Selective (following Dynamic Sentinel Node Biopsy - DSNB) Inguinal Lymph-Node Dissection (ILND).

We evaluated the oncologic efficacy of early inguinal lymph-node dissection (ILND), observation or dynamic sentinel node biopsy (DSNB) followed by delayed or selective ILND in cN0 patients with penile squamous cell carcinoma (peSCC).

Between 1980 and 2017 included, 296 evaluable consecutive cN0 peSCC patients underwent early ILND (16), observation (114) or DSNB (166). Median follow-up was 50 months. Tumor stage, grade, lympho-vascular invasion (LVI) and age were considered. Kaplan-Meier plots illustrated 5-year inguinal relapse (IR)-free and cancer specific survival (CSS) rates. Multivariable Cox Regression models (MCRMs) tested the treatment effect. Analyses were repeated after inverse probability of treatment weighting adjustment (IPTW).

The 5-year IR-free survival and CSS rates following early, observation and DSNB ILND were 100%, 87%, 89%, and 84%, 81%, 85%, respectively. The 5-year crude IR-free survival and CSS rates were 90% and 93% in low-risk patients undergoing observation. Clavien grade 3 complications were 0.6 Vs 12.5% in DSNB and early ILND group, respectively. After IPTW adjustment, 5-year IR and CSS were 90% vs 73% and 90% vs 77% following DSNB and observation, respectively. At MCRMs, patients undergoing DSNB had significantly lower IR (HR 0.4, CI 0.2-0.85, p 0.02) and CSM (HR 0.29, CI 0.11-0.77; p- 0.01) compared to those under observation. The low number of patients undergoing early ILND made a reliable comparison with this group impractical.

Selective ILND following DSNB significantly improved IR and CSM when compared with observation, providing evidence of efficacy of DSNB in clinical stage N0 peSCC patients.

The Journal of urology. 2021 Apr 12 [Epub ahead of print]

Sebastiano Nazzani, Mario Catanzaro, Davide Biasoni, Marco Maccauro, Carlotta Zaborra, Silvia Stagni, Tullio Torelli, Alberto Macchi, Antonio Tesone, Alice Lorenzoni, Luigi Piva, Rodolfo Lanocita, Maurizio Colecchia, Emanuele Montanari, Roberto Salvioni, Giorgio Pizzocaro, Nicola Nicolai

Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Nuclear Medicine Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Radiology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy., Urology Department, Policlinico, Università degli Studi di Milano.