Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multi-centre randomised trial
To find whether postoperative pelvic radiotherapy improves locoregional control and survival for patients with stage-1 endometrial carcinoma
Type of study
Randomised controlled trial (RCT)
Pelvic radiotherapy or No radiotherapy after hysterectomy & bilateral salpingoopherectomy (without lymphadenectmy)
Experimental arm (Intervention)
Pelvic radiotherapy (46 Gy) following surgery (total abdominal hysterectomy and bilateral salpingo-oophorectomy, peritoneal washing without routine lymphadenectomy – biopsy from suspicious lymph nodes).
No further treatment following surgery
Locoregional recurrence and Death
Treatment-related morbidity and Survival after relapse
Patients with post-operative histo-pathologically proven stage-1 endometrial carcinoma
- Grade 1 with deep [≥50%] myometrial invasion
- Grade 2 with any invasion
- Grade 3 with superficial [<50%] invasion)
- Any FIGO stage 1B and 1C (FIGO staging 1988)
- History of invasive cancer (except for basal cell carcinoma of the skin)
- Previously received chemotherapy, hormonal therapy, or radiotherapy
- WHO – performance score >2
- Post-relapse survival rate @2 year / 3 years post-relapse was significantly higher in those with locoregional recurrence (79% / 69%) vs. those with distant metastasis (21% / 13%), p<0.001.
- Patient< 60 years age had lower risk of locoregional recurrence (4% vs 10%, p=0.02) compared to patients >60 years old.
- Patients <60 years old had a lower risk of death (4% vs 9%, p=0.02) when compared to those > 60 years old.
- Lower grade of endometrial cancer associated with less distant metastasis and lower death rates. Grade 3 endometrial cancers had 14% risk of distant metastasis vs 1% in grade 1 and 5% in grade 2 cancers
- Patients with high grade cancer had 16% increased risk of death when compared to low grade cancer (p=0.0008).
- The reduction of incidence of locoregional recurrence in the radiotherapy arm was not translated into a survival benefit
- Distant metastasis was similar in both groups
- Patients < 60 years (except with grade 3 tumours) have significantly reduced rates of local recurrence and death
- Not taken into consideration differences in surgical proficiency
- Both groups had similar mean age but higher proportion of patients below 60 in the control group
- Not taken into account the difference in the histological subtypes between the groups (more non-endometroid cancers in radiotherapy group)
Emad S. Nasr