Stefano Tappero1,2,3, Mattia Piccinelli4,5, Francesco Barletta4,6, Andrea Panunzio4,7, Cristina Cano Garcia4,8, Reha-Baris Incesu4,9, Zhe Tian4, Stefano Parodi10,11, Paolo Dell'Oglio12,13,14, Ottavio De Cobelli5, Alberto Briganti6, Alessandro Antonelli7, Felix K H Chun8, Markus Graefen9, Fred Saad4, Shahrokh F Shariat15,16,17,18, Nazareno R Suardi19, Marco Borghesi10,11, Carlo Terrone10,11, Pierre I Karakiewicz4. 1. Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, QC, Canada. stefano.m.tappero@gmail.com. 2. Department of Urology, IRCCS Policlinico San Martino, Largo R. Benzi 10, 16132, Genoa, Italy. stefano.m.tappero@gmail.com. 3. Department of Surgical and Diagnostic Integrated Sciences (DISC), University of Genova, Genoa, Italy. stefano.m.tappero@gmail.com. 4. Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, QC, Canada. 5. Department of Urology, IEO European Institute of Oncology, IRCCS, Milan, Italy. 6. Division of Experimental Oncology/Unit of Urology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy. 7. Department of Urology, University of Verona, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy. 8. Department of Urology, University Hospital Frankfurt, Goethe University Frankfurt am Main, Frankfurt am Main, Germany. 9. Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 10. Department of Urology, IRCCS Policlinico San Martino, Largo R. Benzi 10, 16132, Genoa, Italy. 11. Department of Surgical and Diagnostic Integrated Sciences (DISC), University of Genova, Genoa, Italy. 12. Department of Urology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy. 13. Department of Urology, Netherlands Cancer Institute-Antoni Van Leeuwenhoek Hospital, Amsterdam, The Netherlands. 14. Interventional Molecular Imaging Laboratory, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands. 15. Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. 16. Department of Urology, Weill Cornell Medical College, New York, NY, USA. 17. Department of Urology, University of Texas Southwestern, Dallas, TX, USA. 18. Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan. 19. Department of Urology, Spedali Civili of Brescia, Brescia, Italy.
Abstract
INTRODUCTION: The survival benefit of inguinal lymph node dissection (ILND) vs no ILND in patients with squamous cell carcinoma of the penis (SCCP) and the absence of lymph node invasion is unclear. We addressed this uncertainty within the Surveillance, Epidemiology and End Results (SEER 2000-2018) database. MATERIAL AND METHODS: We identified lymph node negative SCCP patients who either underwent ILND (pN0) or clinical examination only (cN0). We tested for the effect of ILND vs no ILND on cancer-specific mortality (CSM) in Kaplan-Meier plots, univariable and multivariable Cox regression analyses, in a pT stage-specific fashion, before and after 1:3 propensity score matching (PSM). Sensitivity analyses were conducted according to historical and contemporary treatment periods as well as geographic regions. RESULTS: Of 2520 SCCP patients, 369 (15%) underwent ILND (pN0) vs 2151 (85%) did not (cN0). The pN0 vs cN0 distribution according to pT stages was as follows: 80 (7%) vs 1092 (93%) in pT1b, and 289 (21%) vs 1059 (79%) in pT2-3. At 36 months, CSM-free survival in pT2-3 stage was 89% in ILND vs 74% in no ILND patients (multivariable hazard ratio: 0.42, CI 0.30-0.60, p < 0.001). This result was confirmed in sensitivity analyses, and after 1:3 PSM. The same analyses could not be completed in pT1b stage due to insufficient number of observations and events. CONCLUSIONS: In pT2-3 stage SCCP, a significantly lower CSM was recorded in lymph node negative patients treated with ILND than in their clinical lymph node negative counterparts who did not undergo ILND.
INTRODUCTION: The survival benefit of inguinal lymph node dissection (ILND) vs no ILND in patients with squamous cell carcinoma of the penis (SCCP) and the absence of lymph node invasion is unclear. We addressed this uncertainty within the Surveillance, Epidemiology and End Results (SEER 2000-2018) database. MATERIAL AND METHODS: We identified lymph node negative SCCP patients who either underwent ILND (pN0) or clinical examination only (cN0). We tested for the effect of ILND vs no ILND on cancer-specific mortality (CSM) in Kaplan-Meier plots, univariable and multivariable Cox regression analyses, in a pT stage-specific fashion, before and after 1:3 propensity score matching (PSM). Sensitivity analyses were conducted according to historical and contemporary treatment periods as well as geographic regions. RESULTS: Of 2520 SCCP patients, 369 (15%) underwent ILND (pN0) vs 2151 (85%) did not (cN0). The pN0 vs cN0 distribution according to pT stages was as follows: 80 (7%) vs 1092 (93%) in pT1b, and 289 (21%) vs 1059 (79%) in pT2-3. At 36 months, CSM-free survival in pT2-3 stage was 89% in ILND vs 74% in no ILND patients (multivariable hazard ratio: 0.42, CI 0.30-0.60, p < 0.001). This result was confirmed in sensitivity analyses, and after 1:3 PSM. The same analyses could not be completed in pT1b stage due to insufficient number of observations and events. CONCLUSIONS: In pT2-3 stage SCCP, a significantly lower CSM was recorded in lymph node negative patients treated with ILND than in their clinical lymph node negative counterparts who did not undergo ILND.
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