Modified radical hysterectomy versus extrafascial hysterectomy in the treatment of stage I endometrial cancer: results from the ILIADE randomized study.
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.
Signorelli
Mauro
M
Department of Obstetrics and Gynecology, University of Milano-Bicocca, S. Gerardo Hospital, Monza, Italy.
Lissoni
Andrea Alberto
AA
Cormio
Gennaro
G
Katsaros
Dionyssios
D
Pellegrino
Antonio
A
Selvaggi
Luigi
L
Ghezzi
Fabio
F
Scambia
Giovanni
G
Zola
Paolo
P
Grassi
Roberto
R
Milani
Rodolfo
R
Giannice
Raffaella
R
Caspani
Giovanna
G
Mangioni
Costantino
C
Floriani
Irene
I
Rulli
Eliana
E
Fossati
Roldano
R
D018262:Adenocarcinoma, Clear Cell / Q000473:pathology / Q000601:surgery*; D002288:Adenocarcinoma, Mucinous / Q000473:pathology / Q000601:surgery*; D000293:Adolescent; D000328:Adult; D000368:Aged; D018196:Carcinoma, Adenosquamous / Q000473:pathology / Q000601:surgery*; D018284:Cystadenocarcinoma, Serous / Q000473:pathology / Q000601:surgery*; D016889:Endometrial Neoplasms / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult