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#142 An international randomized phase III trial comparing radical hysterectomy and pelvic node dissection (RH) vs simple hysterectomy and pelvic node dissection (SH) in patients with low-risk early-stage cervical cancer (LRESCC)
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  1. Marie Plante1,
  2. Janice Kwon2,
  3. Sarah Ferguson3,
  4. Vanessa Samouëlian4,
  5. Gwenael Ferron5,
  6. Amandine Maulard6,
  7. Cor De Kroon7,
  8. Willemien van Driel8,
  9. John Tidy9,
  10. Karin Williamson10,
  11. Sven Mahner11,
  12. Stefan Kommoss12,
  13. Frederic Goffin13,
  14. Karl Tamussino14,
  15. Brynhildur Eyjólfsdóttir15,
  16. Jae-Weon Kim16,
  17. Noreen Gleeson17,
  18. Lori Brotto18,
  19. Dongsheng Tu19 and
  20. Lois E Shepherd20
  1. 1Centre Hospitalier Universitaire de Quebec, L’Hotel-Dieu de Quebec, Quebec, Canada
  2. 2University of British Columbia, Vancouver, Canada
  3. 3Pincess Margaret Hospital, Toronto, Canada
  4. 4Centre Hospitalier de l’Université de Montréal, Montreal, Canada
  5. 5Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France
  6. 6Gustave Roussy Cancer Center, Villejuif, France
  7. 7Leiden University Medical Center,, Leiden, Netherlands Antilles
  8. 8Netherlands Cancer Institute, Amsterdam, Netherlands Antilles
  9. 9Royal Hallamshire Hospital,, Sheffield, UK
  10. 10Nottingham University Hospitals, UK
  11. 11LMU University Hospital, Nottingham, Germany
  12. 12Tuebingen University Hospital, Munich, Germany
  13. 13CHU de Liege, Tuebingen, Belgium
  14. 14Medical University of Graz, Liege, Austria
  15. 15Oslo University Hospital, Graz, Norway
  16. 16Seoul National University College of Medicine, Oslo, South Korea
  17. 17St James’ Hospital, Seoul, Ireland
  18. 18University of British Columbia, Dublin, Canada
  19. 19Canadian Cancer Trials Group, Queen’s University, Vancouver, Canada
  20. 20Canadian Cancer Trials Group, Queen’s University, Kingston, Canada

Abstract

Introduction/Background The objective of this non-inferiority phase III prospective randomized trial was to compare RH to SH in women with LRESCC.

Methodology Women with LRESCC defined as stage IA2 or IB1 disease with lesions ≤2cm were randomized to RH or SH. The primary endpoint was pelvic recurrence rate at 3 years (PRR3). Primary intention to treat (ITT) analysis included all patients randomized. Secondary endpoints included extra-pelvic relapse-free survival (EPRFS), overall survival (OS) and patient reported outcome.

Results 700 women were enrolled from December 2012 to November 2019. Median age was 44 (24-80); 91.7% were stage 1B1 and 61.7% were squamous histology. On final pathology, lymph node metastasis occurred in 3.7% (3.3% SH and 4.4% RH), positive margins in 2.5% (2.1% SH and 2.9% RH), and lesions >2cm in 4.25% (4.4% SH and 4.1% RH). A total of 8.8% of women received post-surgical adjuvant therapy (9.2% SH and 8.4% RH). With a median follow-up of 4.5 years, 21 pelvic recurrences occurred (11 SH and 10 RH). The PRR3 was 2.52% with SH and 2.17% with RH (difference 0.35% with 95% upper confidence limit 2.32%) in ITT analysis. The 3-year EPRFS and OS were respectively 98.1% and 99.1% with SH; 99.7% and 99.4% with RH. SH had less bladder (9 vs 3) and ureteral injuries (5 vs 3) and significantly less urinary incontinence (4.7% vs. 11.0%; p=0.003) and urinary retention (0.6% vs. 9.9%; p<0.0001) compared to RH. QoL scales with significant difference between the two groups over time were all in favor of SH.

Conclusion The pelvic recurrence rate at 3 years in women with LRESCC who underwent SH was not inferior to RH and was associated with fewer surgical complications and better QoL.. SH should be considered the new standard of care.

Disclosures None

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