ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer

Kathleen M. Schmeler, Rene Pareja, Aldo L. Blanco, Jose Humberto Fregnani, Andre Lopes, Myriam Perrotta, Audrey T. Tsunoda, David F. Cantú-De-León, Lois M. Ramondetta, Tarinee Manchana, David R. Crotzer, Orla M. McNally, Martin Riege, Giovanni Scambia, Juan Manuel Carvajal, Julian Di Guilmi, Gabriel J. Rendon, Preetha Ramalingam, Bryan M. Fellman, Robert L. ColemanMichael Frumovitz, Pedro T. Ramirez

Research output: Contribution to journalArticlepeer-review

86 Scopus citations

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 abov 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 hysterectom 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.

Original languageEnglish (US)
Pages (from-to)1317-1325
Number of pages9
JournalInternational Journal of Gynecological Cancer
Volume31
Issue number10
DOIs
StatePublished - Oct 2021

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

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