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Modified Radical Hysterectomy Versus Extrafascial Hysterectomy in the Treatment of Stage I Endometrial Cancer: Results From the ILIADE Randomized Study

  • Gynecologic Oncology
  • Published:
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Abstract

Background

Five percent to 20% of stage I endometrial cancer patients undergoing total abdominal hysterectomy and bilateral salpingo-oophorectomy develop vaginal and pelvic recurrences. Adjuvant radiotherapy can improve locoregional control but not survival. This randomized trial aimed to determine whether a modified radical (Piver–Rutledge class II) hysterectomy can improve survival and locoregional control compared to the standard extrafascial (Piver–Rutledge class I) hysterectomy.

Methods

Eligible patients (n = 520) with stage I endometrial cancer were randomized to class I or class II hysterectomy. Primary endpoint was overall survival.

Results

The median length of parametria and vagina removed were 15 and 5 vs. 20 mm and 15 mm for class I and class II hysterectomy, respectively (P > 0.001). Operating time and blood loss were statistically significantly higher for class II hysterectomy. At a median follow-up of 70 months, 51 patients had died. Five-year disease-free and overall survival were similar between arms (87.7 and 88.9% in the class I arm and 89.7 and 92.2% in the class II arm, respectively). The unadjusted hazard ratios for recurrence was 0.91 (95% confidence interval, 0.55–1.51, P = 0.72), and the hazard ratio for death was 0.77 (95% confidence interval, 0.44–1.33, P = 0.35).

Conclusions

Class II hysterectomy did not improve locoregional control and survival compared to class I hysterectomy, but when an adequate vaginal cuff transection is not feasible with class I hysterectomy, a modified radical hysterectomy allows to obtain an optimal vaginal and pelvic control of disease with a minimal increase in surgical morbidity.

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Acknowledgment

We thank Fondazione Mattioli, who provided support for Data Management. Trial registered in the National Monitoring Centre for Clinical Trials (http://oss-sper-clin.agenziafarmaco.it/project.htm), trial code ILIADE.

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Correspondence to Roldano Fossati MD.

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Signorelli, M., Lissoni, A.A., Cormio, G. et al. Modified Radical Hysterectomy Versus Extrafascial Hysterectomy in the Treatment of Stage I Endometrial Cancer: Results From the ILIADE Randomized Study. Ann Surg Oncol 16, 3431–3441 (2009). https://doi.org/10.1245/s10434-009-0736-6

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  • DOI: https://doi.org/10.1245/s10434-009-0736-6

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