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Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer
Marie Plante1, Janice S Kwon1, Sarah Ferguson1
1From Centre Hospitalier Universitaire de Québec, Quebec (M.P.), the University of British Columbia, Vancouver (J.S.K., L.B.), Princess Margaret Hospital, Toronto (S.F.), Centre Hospitalier de l'Université de Montréal, Montreal (V.S.), and the Canadian Cancer Trials Group, Queen's University, Kingston, ON (D.T., L.E.S.) - all in Canada; Institut Claudius Regaud, IUCT-Oncopole, Toulouse (G.F.), and Gustave Roussy Cancer Center, Villejuif (A.M.) - both in France; Leiden University Medical Center, Leiden (C.K.), and the Netherlands Cancer Institute, Amsterdam (W.V.D.) - both in the Netherlands; Royal Hallamshire Hospital, Sheffield (J.T.), and Nottingham University Hospitals, Nottingham (K.W.) - both in the United Kingdom; LMU University Hospital, Munich (S.M.), and University of Tübingen Hospital, Tübingen (S.K.) - both in Germany; Centre Hospitalier Universitaire de Liege, Liege, Belgium (F.G.); Medical University of Graz, Graz, Austria (K.T.); Oslo University Hospital, Oslo (B.E.); Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); and St. James' Hospital, Dublin (N.G.).
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.).
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