Modified radical hysterectomy versus extrafascial hysterectomy in the treatment of stage i endometrial cancer: Results from the ILIADE randomized study

Mauro Signorelli, Andrea Alberto Lissoni, Gennaro Cormio, Dionyssios Katsaros, Antonio Pellegrino, Luigi Selvaggi, Fabio Ghezzi, Giovanni Scambia, Paolo Zola, Roberto Grassi, Rodolfo Milani, Raffaella Giannice, Giovanna Caspani, Costantino Mangioni, Irene Floriani, Eliana Rulli, Roldano Fossati

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)3431-3441
Number of pages11
JournalAnnals of Surgical Oncology
Volume16
Issue number12
DOIs
Publication statusPublished - Dec 2009

ASJC Scopus subject areas

  • Surgery
  • Oncology

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    Signorelli, M., Lissoni, A. A., Cormio, G., Katsaros, D., Pellegrino, A., Selvaggi, L., Ghezzi, F., Scambia, G., Zola, P., Grassi, R., Milani, R., Giannice, R., Caspani, G., Mangioni, C., Floriani, I., Rulli, E., & Fossati, R. (2009). Modified radical hysterectomy versus extrafascial hysterectomy in the treatment of stage i endometrial cancer: Results from the ILIADE randomized study. Annals of Surgical Oncology, 16(12), 3431-3441. https://doi.org/10.1245/s10434-009-0736-6