Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer

Marie Plante, Janice S Kwon, Sarah Ferguson, Vanessa Samouëlian, Gwenael Ferron, Amandine Maulard, Cor de Kroon, Willemien Van Driel, John Tidy, Karin Williamson, Sven Mahner, Stefan Kommoss, Frederic Goffin, Karl Tamussino, Brynhildur Eyjólfsdóttir, Jae-Weon Kim, Noreen Gleeson, Lori Brotto, Dongsheng Tu, Lois E ShepherdCX.5 SHAPE investigators

Research output: Contribution to journalOriginal Article (Journal)peer-review

7 Citations (Web of Science)

Abstract

BACKGROUND: Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients. However, data from large, randomized trials comparing outcomes of radical and simple hysterectomy are lacking.

METHODS: We conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). The primary outcome was cancer recurrence in the pelvic area (pelvic recurrence) at 3 years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years was 4 percentage points.

RESULTS: Among 700 patients who underwent randomization (350 in each group), the majority had tumors that were stage IB1 according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%). With a median follow-up time of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group (an absolute difference of 0.35 percentage points; 90% confidence interval, -1.62 to 2.32). Results were similar in a per-protocol analysis. The incidence of urinary incontinence was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (2.4% vs. 5.5%; P = 0.048) and beyond 4 weeks (4.7% vs. 11.0%; P = 0.003). The incidence of urinary retention in the simple hysterectomy group was also lower than that in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001).

CONCLUSIONS: In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.).

Original languageEnglish
Pages (from-to)819-829
Number of pages11
JournalNEW ENGLAND JOURNAL OF MEDICINE
Volume390
Issue number9
DOIs
Publication statusPublished - 29 Feb 2024

Keywords

  • Female
  • Humans
  • Canada
  • Carcinoma, Squamous Cell/pathology
  • Hysterectomy/adverse effects
  • Lymph Nodes/pathology
  • Neoplasm Recurrence, Local/epidemiology
  • Neoplasm Staging
  • Prognosis
  • Retrospective Studies
  • Urinary Incontinence/etiology
  • Urinary Retention/etiology
  • Uterine Cervical Neoplasms/pathology
  • Management
  • Survival
  • Conization
  • Parametrectomy
  • Surgery

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