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444 Survival of patients with early stages cervical cancer after SLN biopsy without systematic pelvic lymphadenectomy: survival outcomes of the SENTIX prospective single-arm international trial (CEEGOG CX-01; ENGOT-CX2)
  1. David Cibula1,
  2. Simone Marnitz2,
  3. Jaroslav Klát3,
  4. Jiri Jarkovsky4,
  5. Giampaolo Di Martino5,
  6. Luc Rcw Van Lonkhuijzen6,
  7. Ignacio Zapardiel Gutiérrez7,
  8. Michal Zikan8,
  9. Octavio Arencibia-Sánchez9,
  10. Francesco Raspagliesi10,
  11. Jiri Presl11,
  12. Lubos Minar12,
  13. Ariel Glickman13,
  14. Marcela Ostojich14,
  15. Almerinda Petiz15,
  16. Spela Smrkolj16,
  17. Toon Van Gorp17,
  18. Roman Kocián18,
  19. Kristyna Nemejcova19 and
  20. Christhardt Köhler20
  1. 1First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic
  2. 2Radiation Oncology Vosspalais, Berlin, Germany
  3. 3University Hospital Ostrava, Department of Obstetrics and Gynecology, CEEGOG, Ostrava, Czech Republic
  4. 4Faculty of Medicine, Masaryk University, Institute of Biostatistics and Analyses, Brno, Czech Republic
  5. 5San Gerardo Hospital, Department of Obstetrics and Gynecology, Unit of Gynecologic Oncology Surgery, Milano, Italy
  6. 6Center for Gynaecologic Oncology Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands
  7. 7La Paz University Hospital, Madrid, Spain
  8. 8First Faculty of Medicine, Charles University and University Hospital Bulovka, Department of Gynecology and Obstetrics, Prague, Czech Republic
  9. 9Maternal and Child University Hospital of Canary Islands, Las Palmas De Gran Canaria, Spain
  10. 10Fondazione IRCCS Istituto Nazionale dei Tumori, Gynecological Oncology Unit, Milan, Italy
  11. 11Faculty of Medicine in Pilsen, Charles University and University Hospital Pilsen, Department of Obstetrics and Gynecology, Pilsen, Czech Republic
  12. 12Dept. Obstet. Gynecol., Univ. Hosp. Brno and Medical Faculty Masaryk University, Brno, Czech Republic
  13. 13Clinical Institute of Gynecology, Obstetrics and Neonatology (ICGON) Hospital Clinic Barcelona, Barcelona, Spain
  14. 14Institute of Oncology Angel H. Roffo. University of Buenos Aires Department of Gynecology, Buenos Aires, Argentina
  15. 15Francisco Gentil Portuguese Oncology Institute, Department of Gynecology, Porto, Portugal
  16. 16Department of Gynaecology and Obstetrics, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
  17. 17University Hospital Leuven Leuven Cancer Institute, Leuven, Belgium
  18. 18First Faculty of Medicine, Charles University and General University Hospital in Prague, Department of Obstetrics and Gynecology, CEEGOG, Prague, Czech Republic
  19. 19Department of Pathology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic, Prague, Czech Republic
  20. 20Asklepios-Clinic Hamburg Altona, Department of Gynaecology, Hamburg, Germany


Introduction/Background The SENTIX was an international, multicentre, prospective single-arm study on sentinel lymph node (SLN) biopsy without systematic pelvic lymphadenectomy in patients with early-stage cervical cancer. Here, we report the final survival outcomes of the study.

Methodology Forty-seven sites across 18 countries participated in the study. Patients stages 1A1/LVSI+ - 1B2 (FIGO 2018), common histological types and no preoperatively suspicious lymph-nodes (LN) were prospectively enrolled between 05/2016–10/2020. All intention-to-treat (ITT) patients underwent bilateral SLN biopsy, followed by hysterectomy or trachelectomy. All harvested SLNs were completely processed by centrally controlled pathological ultrastaging. NCT02494063.

Results A total of 594 ITT patients were enrolled, majority of which had squamous cell carcinoma (66.0%) and IB disease (IB1=46.8%; IB2=36.9%). Ultrastaging examination detected N1 SLN in 36 (6.1%) and isolated tumour cells in 20 (3.4%) patients. All N1 patients underwent adjuvant (chemo)radiotherapy.

2-year disease-free survival (DFS) was 93.3% (95% CI: 94.9%; 91.6%), and overall survival (OS) 97.9% (95% CI: 98.9%; 97.0%). After a median follow-up of 47 months, 54 (9.1%) patients relapsed, out of which 20 (3.4%) died. The recurrence was pelvic, extra-pelvic, and combined in 28 (51.9%), 13 (24.1%), and 13 (24.1%) patients, respectively. A Cox proportional hazards model showed that DFS was related to tumour size (HR for >4 cm: 5.23), tumour grade 3 (HR: 4.24), and LVSI (HR: 2.65). No DFS benefit was found for open surgical approach (P = 0.39), and no negative impact of N1 SLN involvement (0.434) was observed.

Conclusion The study showed that 2-year DFS and OS in patients after SLN biopsy is excellent and comparable to patients after PLND, reported in the recent prospective trials. In early-stage cervical cancer patients, SLN biopsy with pathological ultrastaging and no further lymphadenectomy is not associated with increased risk of recurrence.

Disclosures Disclosures: The authors declare no conflict of interest.

Funding This work was supported by Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1) and by a grant from the Czech Health Research Council (NV19–03-00023). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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