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ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer
  1. Kathleen M Schmeler1,
  2. Rene Pareja2,
  3. Aldo Lopez Blanco3,
  4. Jose Humberto Fregnani4,
  5. Andre Lopes5,
  6. Myriam Perrotta6,
  7. Audrey T Tsunoda7,
  8. David F Cantú-de-León8,
  9. Lois M Ramondetta1,
  10. Tarinee Manchana9,
  11. David R Crotzer10,
  12. Orla M McNally11,
  13. Martin Riege12,
  14. Giovanni Scambia13,
  15. Juan Manuel Carvajal14,
  16. Julian Di Guilmi15,
  17. Gabriel J Rendon16,
  18. Preetha Ramalingam17,
  19. Bryan M Fellman18,
  20. Robert L Coleman19,
  21. Michael Frumovitz1 and
  22. Pedro T Ramirez1
  1. 1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  2. 2Instituto Nacional de Cancerología, Bogotá, and Clínica de Oncología Astorga, Medellin, Colombia
  3. 3Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru
  4. 4A.C. Camargo Cancer Center, A.C. Camargo Cancer Center, Sao Paulo, Brazil
  5. 5Instituto Brasileiro de Controle do Cancer, Sao Paulo, Brazil
  6. 6Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
  7. 7Hospital Erasto Gaertner, Curitiba, Brazil
  8. 8Instituto Nacional de Cancerologia, Mexico, Mexico
  9. 9Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand
  10. 10Nebraska Methodist Health System, Omaha, Nebraska, USA
  11. 11Royal Women's Hospital and University of Melbourne, Melbourne, Victoria, Australia
  12. 12Instituto de Ginecología de Rosario, Rosario, Argentina
  13. 13Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome, Italy
  14. 14Matamoros General Hospital Alfredo Pumarejo, Matamoros, Mexico
  15. 15Hospital Británico de Buenos Aires, Buenos Aires, Argentina
  16. 16Instituto de Cancerologia - Las Américas - AUNA, Medellin, Colombia
  17. 17Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  18. 18Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  19. 19US Oncology Research, The Woodlands, Texas, USA
  1. Correspondence to Dr Kathleen M Schmeler, Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77230, USA; KSchmele{at}mdanderson.org

Abstract

Objective The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer.

Methods From April 2010 to March 2019, a prospective, single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2–IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size <2 cm; (4) no lymphovascular space invasion; (5) depth of invasion <10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an ‘inadvertent’ simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the above inclusion criteria and underwent a second surgery with pelvic lymph node dissection only.

Results 100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23–67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectomy specimen was noted in 1/40 patients—that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0–68.3). Three patients developed recurrent disease within 2 years of surgery—that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%).

Discussion Our prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.

  • cervix uteri
  • hysterectomy
  • surgery
  • lymph nodes

Data availability statement

Data are available upon reasonable request. In accordance with the journal’s guidelines, we will provide our data for the reproducibility of this study in other centers if such is requested. The data are in a REDCap database at MD Anderson Cancer Center and are available from the principal investigator, Dr. Kathleen Schmeler.

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Data availability statement

Data are available upon reasonable request. In accordance with the journal’s guidelines, we will provide our data for the reproducibility of this study in other centers if such is requested. The data are in a REDCap database at MD Anderson Cancer Center and are available from the principal investigator, Dr. Kathleen Schmeler.

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Footnotes

  • Twitter @Andrelopes1002, @frumovitz, @pedroramirezMD

  • Presented at This study was presented in part at the annual meeting of the International Gynecologic Cancer Society (IGCS), Rio de Janeiro, Brazil, September 2019.

  • Contributors Conception and design: KMS, PTR, MF, RP, RLC. Administrative support: KMS, PTR, RLC. Provision of study material or patients: all authors. Collection and assembly of data: KMS, BMF, PR, PTR, RP, RLC. Data analysis and interpretation: BMF, KMS, PTR, MF, RP, RLC. Manuscript writing: all authors. Final approval of manuscript: all authors. Accountable for all aspects of the work: all authors.

  • Funding This research was supported in part by the National Institutes of Health (NIH) through MD Anderson’s Cancer Center Support Grant P30CA016672 and the MD Anderson Sister Institution Network Fund.

  • Competing interests The authors have the following disclosures: MH: consulting/speaker for Stryker and research support from GlaxoSmithKline and Astra Zeneca.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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