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Proof-of-concept randomized phase II non-inferiority trial of simple versus type B2 hysterectomy in early-stage cervical cancer ≤2 cm (LESSER)
  1. Vandré Cabral Gomes Carneiro1,2,
  2. Thales Paulo Batista1,3,
  3. Manoel Rodrigues Andrade2,4,
  4. Aldo Vieira Barros5,
  5. Luciana Holanda Lima Dornelas Câmara6,
  6. Nathalia Moreira Ramalho4,
  7. Márcia Angélia Lucena2,7,
  8. Diogenes Fernando Santos Fontão2,4,
  9. Rodrigo Tancredi8,9,
  10. Tyrone César Silva Júnior4,
  11. Artur Lício Rocha Bezerra4,7 and
  12. Glauco Baiocchi10
  1. 1Surgery/Oncology, Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil
  2. 2Gynecology, Hospital de Cancer de Pernambuco, Recife, Brazil
  3. 3Surgery, UFPE, Recife, Brazil
  4. 4Gynecology, Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil
  5. 5Surgery/Oncology, Santa Casa de Misericórdia de Maceió, Maceio, Brazil
  6. 6Surgery, Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil
  7. 7Surgery/Oncology, Universidade de Pernambuco, Recife, Brazil
  8. 8Clinical Oncology, Instituto de Medicina Integral Professor Fernando Figueira, Recife, Brazil
  9. 9Clinical Oncology, Hospital de Cancer de Pernambuco, Recife, Brazil
  10. 10Gynecology, A C Camargo Cancer Center, Sao Paulo, Brazil
  1. Correspondence to Dr Thales Paulo Batista, Surgery, UFPE, Recife 50010, Brazil; t.paulo{at}outlook.com

Abstract

Objective To evaluate the non-inferiority and safety of simple hysterectomy in early stage (<2 cm) cervical cancer.

Methods This proof-of-concept randomized phase II non-inferiority trial was performed between May 2015 and April 2018 in three oncological centers in Northeast Brazil. Patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IA2–IB1 cervical cancer and tumors ≤2 cm were treated with either simple or modified radical hysterectomy (Querleu–Morrow type B2). Intention-to-treat analysis was carried out. The primary endpoint was 3-year disease-free survival and secondary endpoints were overall survival, operative outcomes, adjuvant therapy, and patient’s health-related quality of life (QoL).

Results A total of 40 patients underwent either simple hysterectomy (n=20) or modified radical hysterectomy (n=20). All patients except three underwent open procedures (n=37/40, 92.5%). At a median follow-up of 52.1 months (IQR 43.9–60.1), 3-year disease-free survival was 95% (95% CI 68% to 99%) after simple hysterectomy and 100% (95% CI 100% to 100%) after modified radical hysterectomy (log-rank p=0.30). The corresponding 5-year overall survival rates were 90% (95% CI 64% to 97%) and 91% (95% CI 50% to 98%), respectively (log-rank p=0.46). The operative time was shorter after simple hysterectomy than after modified radical hysterectomy (150 min (IQR 137.5–180) vs 199.5 min (IQR 140–230); p=0.003), with a trend towards a longer time for vesical catheterization removal (1 day (IQR 1–1) vs 1 day (IQR 1–2); p=0.043). There was no post-operative mortality and the rates of post-operative complications were not statistically different between arms (15% and 25%; p=0.69). QoL questionnaires were received from only 17 patients (42.5%), with no major differences observed over time between the surgical arms.

Conclusions Simple hysterectomy is safe and potentially non-inferior to the radical surgery in patients with early-stage cervical cancer ≤2 cm.

Trial Registration number NCT02613286.

  • Hysterectomy
  • Cervix Uteri
  • Surgical Procedures, Operative
  • Gynecologic Surgical Procedures

Data availability statement

No data are available. We have no plan to make individual participant data (IPD) available to other researchers since data sharing was not required in the study protocol initially reviewed and approved by our Ethics Research Committees (Institutional Review Boards).

https://doi.org/10.1136/ijgc-2022-004092

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    Data availability statement

    No data are available. We have no plan to make individual participant data (IPD) available to other researchers since data sharing was not required in the study protocol initially reviewed and approved by our Ethics Research Committees (Institutional Review Boards).

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    Footnotes

    • Twitter @BatistaTP, @GlaucoBaiocchi

    • Contributors VCGC: formal analysis, investigation, data curation, writing - original draft and review & editing, and project administration. TPB: conceptualization, methodology, formal analysis, investigation, data curation, writing - original draft and review & editing, visualization, project administration, and responsible for the overall content as guarantor. MRA, AVB, LHLDC, NMR, MAL, DFSF, RT, TCSJ: investigation, and writing - original draft. ALRB, GB: formal analysis, investigation, writing - original draft and review & editing, and supervision.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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