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.
Similar content being viewed by others
References
Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin. 2008;58:71–6.
Aalders J, Abeler V, Kolstad P, Onsrud M. Postoperative external irradiation and prognostic parameters in stage I endometrial carcinoma. Obstet Gynaecol. 1980;56:419–27.
Creutzberg CL, van Putten WL, Koper PC, et al. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma. Lancet. 2000;355(9213):1404–11.
Keys HM, Roberts JA, Brunetto VL, Gynecologic Oncology Group, et al. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004;92:744–51.
The ASTEC/EN.5 Writing Committee on behalf of the ASTEC/EN.5 Study Group. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2009;373(9658):137–46.
Mariani A, Dowdy SC, Keeney GL, et al. Predictors of vaginal relapse in stage I endometrial cancer. Gynecol Oncol. 2005;97:820–7.
Elliott P, Green D, Coates A, et al. The efficacy of postoperative vaginal irradiation in preventing vaginal recurrence in endometrial cancer. Int J Gynecol Cancer. 1994;4:84–93.
Alektiar KM, McKee A, Venkatraman E, et al. Intravaginal high-dose-rate brachytherapy for Stage IB (FIGO Grade 1, 2) endometrial cancer. Int J Radiat Oncol Biol Phys. 2002;53:707–13.
Creutzberg CL, van Putten WL, Wárlám-Rodenhuis CC, et al.; Postoperative Radiation Therapy in Endometrial Carcinoma Trial. Outcome of high-risk stage IC, grade 3, compared with stage I endometrial carcinoma patients: the Postoperative Radiation Therapy in Endometrial Carcinoma Trial. J Clin Oncol. 2004;22:1234–41.
Scholten AN, van Putten WL, Beerman H, PORTEC Study Group, et al. Postoperative radiotherapy for Stage 1 endometrial carcinoma: long-term outcome of the randomized PORTEC trial with central pathology review. Int J Radiat Oncol Biol Phys. 2005;63:834–8.
Creutzberg CL, van Putten WL, Koper PC, PORTEC Study Group, et al. The postoperative radiation therapy in endometrial carcinoma. The morbidity of treatment for patients with Stage I endometrial cancer: results from a randomized trial. Int J Radiat Oncol Biol Phys. 2001;51:1246–55.
Ng TY, Perrin LC, Nicklin JL, Cheuk R, Crandon AJ. Local recurrence in high-risk node-negative stage I endometrial carcinoma treated with postoperative vaginal vault brachytherapy. Gynecol Oncol. 2000;79:490–4.
Chadha M, Nanavati PJ, Liu P, Fanning J, Jacobs A. Patterns of failure in endometrial carcinoma stage IB grade 3 and IC patients treated with postoperative vaginal vault brachytherapy (review). Gynecol Oncol. 1999;75:103–7.
Horowitz NS, Peters WA 3rd, Smith MR, et al. Adjuvant high dose rate vaginal brachytherapy as treatment of stage I and II endometrial carcinoma. Obstet Gynecol. 2002;99:235–40.
Röper B, Astner ST, Heydemann-Obradovic A, et al. Ten-year data on 138 patients with endometrial carcinoma and postoperative vaginal brachytherapy alone: no need for external-beam radiotherapy in low and intermediate risk patients. Gynecol Oncol. 2007;107:541–8.
Jolly S, Vargas C, Kumar T, et al. Vaginal brachytherapy alone: an alternative to adjuvant whole pelvis radiation for early stage endometrial cancer. Gynecol Oncol. 2005;97:887–92.
Rittenberg PV, Lotocki RJ, Heywood MS, Jones KD, Krepart GV. High-risk surgical stage 1 endometrial cancer: outcomes with vault brachytherapy alone. Gynecol Oncol. 2003;89:288–94.
Vaginal brachytherapy versus external beam pelvic radiotherapy for high-intermediate risk endometrial cancer: results of the randomized PORTEC-2 trial (abstract LBA5503). Paper presented at: 2008 ASCO Annual Meeting, Chicago, IL.
Greven KM, Lanciano RM, Herbert SH, Hogan PE. Analysis of complications in patients with endometrial carcinoma receiving adjuvant irradiation. Int J Radiat Oncol Biol Phys. 1991;21:919–23.
Anderson JM, Stea B, Hallum AV, Rogoff E, Childers J. High-dose-rate postoperative vaginal cuff irradiation alone for stage IB and IC endometrial cancer. Int J Radiat Oncol Biol Phys. 2000;46:417–25.
Piver MS, Rutledge FN, Smith JP. Five classes of extended hysterectomy of women with cervical cancer. Obstet Gynecol. 1974;44:265–70.
Landoni F, Maneo A, Colombo A, et al. Randomised study of radical surgery versus radiotherapy for stage Ib–IIa cervical cancer. Lancet. 1997;350(9077):535–40.
Javert CT, Douglas RG. Treatment of endometrial adenocarcinoma; a study of 381 cases at the New York Hospital; a preliminary report. Am J Roentgenol Radium Ther Nucl Med. 1956;75:508–14.
Rutledge FN. The role of radical hysterectomy in adenocarcinoma of the endometrium. Gynecol Oncol. 1974;2:331–47.
Pagel J, Bock JE. Endometrial cancer. A review. Dan Med Bull. 1984;31:333–45.
Sartori E, Gadducci A, Landoni F, et al. Clinical behavior of 203 stage II endometrial cancer cases: the impact of primary surgical approach and of adjuvant radiation therapy. Int J Gynecol Cancer. 2001;11:430–7.
Cohn DE, Woeste EM, Cacchio S, et al. Clinical and pathologic correlates in surgical stage II endometrial carcinoma. Obstet Gynecol. 2007;109:1062–7.
Eltabbakh GH, Moore AD. Survival of women with surgical stage II endometrial cancer. Gynecol Oncol. 1999;74:80–5.
Maggino T, Romagnolo C, Zola P, et al. An analysis of approaches to the treatment of endometrial cancer in Western Europe: a CTF study. Eur J Cancer. 1995;31:1993–7.
Panici PB, Basile S, Maneschi F, et al. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008;100:1707–16.
Huh WK, Straughn JM Jr, Mariani A, et al. Salvage of isolated vaginal recurrences in women with surgical stage I endometrial cancer: a multiinstitutional experience. Int J Gynecol Cancer. 2007;17:886–9.
Creutzberg CL, van Putten WL, Koper PC, PORTEC Study Group, et al. Survival after relapse in patients with endometrial cancer: results from a randomized trial. Gynecol Onco.l 2003;89:201–9.
Arndt-Miercke H, Martin A, Briese V, et al. Transection of vaginal cuff is an independent prognostic factor in stage I endometrial cancer. Eur J Surg Oncol. 2008;34:241–6.
Landoni F, Maneo A, Cormio G, et al. Class II versus class III radical hysterectomy in stage Ib–IIa cervical cancer: a prospective randomized study. Gynecol Oncol. 2001;80:3–12.
Raspagliesi F, Ditto A, Fontanelli R, et al. Type II versus type III nerve-sparing radical hysterectomy: comparison of lower urinary tract dysfunctions. Gynecol Oncol. 2006;102:256–62.
Zola P, Maggino T, Sacco M, et al. Prospective multicenter study on urologic complications after radical surgery with or without radiotherapy in the treatment of stage IB–IIA cervical cancer. Int J Gynecol Cancer. 2000;10:59–66.
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.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
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
Received:
Published:
Issue Date:
DOI: https://doi.org/10.1245/s10434-009-0736-6