Abstract
Purpose
Analyzing the large patient cohort of the multicenter AGO-CaRE-1 study, we compared isolated sentinel lymph node dissection (SLND) with radical lymph node dissection (LND) of the groin in relation to recurrence rates and survival.
Methods
The AGO-CaRE-1 study retrospectively collected data on treatment patterns and follow-up of vulvar cancer patients [International Federation of Gynecology and Obstetrics (FIGO) stage ≥1B] treated at 29 gynecologic cancer centers between 1998 and 2008. This subgroup analysis evaluated the influence of SLND alone on progression-free survival (PFS) and overall survival (OS).
Results
In 487 (63.1%) of 772 included patients with tumors smaller than 4 cm, an LND was performed and no metastatic lymph nodes were detected (LN0). Another 69/772 (8.9%) women underwent SLND alone, showing a negative SLN (SLN0). Tumors in the LN0 group were larger and showed a deeper invasion (LN0 vs. SLN0 tumor diameter: 20.0 vs. 13.0 mm, p < 0.001; depth of invasion: 4.0 vs. 3.0 mm, p = 0.002). After a median follow-up of 33 months (0–156), no significant differences in relation to isolated groin recurrence rates (SLN0 3.0% vs. LN0 3.4%, p = 0.845) were detected. Similarly, univariate 3-year PFS analysis showed no significant differences between both groups (SLN0 82.7% vs. LN0 77.6%, p = 0.230). A multivariate Cox regression analysis, including tumor diameter, depth of invasion, age, grading, and lymphovascular space invasion was performed: PFS [hazard ratio (HR) 0.970, 95% confidence interval (CI) 0.517–1.821] and OS (HR 0.695, 95% CI 0.261–1.849) did not differ significantly between both cohorts.
Conclusion
This subgroup analysis of the large AGO-CaRE-1 study showed similar results for groin LND and SLND alone with regard to recurrence rates and survival in node-negative patients with tumors <4 cm.
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Acknowledgment
The authors thank the statisticians and staff of the Coordinating Center for Clinical Trials of Philipps-University Marburg for their thorough data management, the AGO Study Group staff for their invaluable organizational help, and the Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO) for their support. The authors also thank the additional investigators and staff at the 29 clinical sites for their work with clinical data and follow-up: Kreisklinik Altoetting; Charité – University Medicine Berlin Charité Campus Virchow; University Hospital Carl Gustav Carus Dresden; Evangelisches Krankenhaus Duesseldorf; University Hospital Erlangen-Nuernberg; Essen Kliniken Essen-Mitte; Essen University Hospital; Johann Wolfgang Goethe-University Hospital Frankfurt; Alb Fils Kliniken Goeppingen; University Hospital Freiburg; Georg-August University Hospital Goettingen; Ernst-Moritz-Arndt University Hospital University Medicine Greifswald; University Hospital Halle; Hamburg Albertinen Krankenhaus; University Medical Center Hamburg-Eppendorf; Hannover Medical School; University Hospital Kiel; University Hospital Cologne; Otto-Guericke University Hospital Magdeburg; Philipps-University Marburg; University Hospital Munich Grosshadern; University Hospital Munich RdI; Sana Klinikum Offenbach; Oberhavel Kliniken Oranienburg; Elblandkliniken Radebeul; Städtisches Klinikum Solingen; University Hospital Tuebingen; University Hospital Ulm; Klinikum Wolfsburg.
Conflict of interest
Rüdiger Klapdor, Peter Hillemanns, Linn Wölber, Julia Jückstock, Felix Hilpert, Nikolaus de Gregorio, Severine Iborra, Jalid Sehouli, Anika Habermann, Sophie Teresa Fürst, Hans Georg Strauß, Klaus Baumann, Falk Thiel, Alexander Mustea, Werner Meier, Philipp Harter, Pauline Wimberger, Lars Hanker, Barbara Schmalfeldt, Ulrich Canzler, Tanja Fehm, Alexander Luyten, Martin Hellriegel, Jens Kosse, Christoph Heiss, Peer Hantschmann, Peter Mallmann, Berno Tanner, Jacobus Pfisterer, Barbara Richter, Martin Jäger, and Sven Mahner declare that there are no conflicts of interest involved with the presented data.
Funding
The CaRE-1 study was supported by Medac Oncology without restriction in protocol or analysis.
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Klapdor, R., Hillemanns, P., Wölber, L. et al. Outcome After Sentinel Lymph Node Dissection in Vulvar Cancer: A Subgroup Analysis of the AGO-CaRE-1 Study. Ann Surg Oncol 24, 1314–1321 (2017). https://doi.org/10.1245/s10434-016-5687-0
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DOI: https://doi.org/10.1245/s10434-016-5687-0