A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma
March 1, 2004
Does addition of adjuvant RT improve survival in high-intermediate risk endometrial cancer?
Surveillance
EBRT 5040 cGy
No brachytherapy
PFS
High-intermediate risk endometrial cancer
Risk factors - (1) Grade 2/3 tumor, (2) LVSI, (3) outer-third myometrial invasion
Patients were included if: (1) 70+ w/1 RF, (2) 50-70 w/2 RF, (3) <50 w/3 RF
Serous and clear cell histology
Unstaged patients
Patients who underwent laparoscopic staging surgery
RTÂ (n=190) vs observation (n=202):
median f/u: 69 mos
4yr OS: 92% vs 86% (NS)
2yr recurrence: 3% vs 12% (SS)
2yr Local recurrences: 1.6% vs 8.9%
Distant recurrences: 5.3% vs 6.4 %
RT associated with increased risks of GI, Hematologic, GU and cutaneous toxicities
2 deaths in RT arm secondary to radiation GI toxicity
Adjuvant pelvic EBRT reduces risk of recurrence in HIR endometrial cancer, without apparent impact on overall survival