PORTEC-1
Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma (PORTEC-1)
N = 715
- Population
- Stage-1 endometrial carcinoma: grade 1 with deep (50% or more) myometrial invasion, grade 2 with any invasion, or grade 3 with superficial (under 50%) invasion; 714 of 715 evaluable
- Design
- Multicentre prospective randomised trial in 19 radiation oncology centres: after total abdominal hysterectomy and bilateral salpingo-oophorectomy without lymphadenectomy, 715 patients were randomised to pelvic radiotherapy (46 Gy) or no further treatment; 714 could be evaluated. Primary endpoints were locoregional recurrence and death; treatment-related morbidity and survival after relapse were secondary. First report median follow-up 52 months; later report (published 2011) median follow-up 13.3 years.
- Primary endpoint
- Locoregional recurrence, OS
- Arms
- No further treatment (control): Surgery alone
- Pelvic radiotherapy (experimental): Pelvic external beam radiotherapy, 46 Gy
- People
- Creutzberg CL, PORTEC Study Group
Δ 60-month Locoregional recurrence−10 pointsΔ 60-month OS−4 pointsΔ Treatment-related complications+19 pointsΔ 180-month Locoregional recurrence−9.5 pointsΔ 180-month OS−8 pointsΔ 180-month FFS−4 points
Show the numbers
| Endpoint | Analysis | Pelvic radiotherapy | No further treatment | Effect |
|---|---|---|---|---|
| Locoregional recurrenceActuarial 5-year locoregional recurrence rate | primarymedian follow-up 52 monthsCreutzberg 2000 | 4% at 5 y | 14% at 5 y | P<0.001714 of the 715 randomised patients could be evaluated. |
| OSActuarial 5-year overall survival | primarymedian follow-up 52 monthsCreutzberg 2000 | 81% at 5 y | 85% at 5 y | P=0.31 |
| Treatment-related complicationsEvaluable patients (714)Proportion of patients with treatment-related complications of any grade; two-thirds were grade 1 and grade 3-4 complications occurred in 2% of the radiotherapy group | primaryCreutzberg 2000 | 25% | 6% | P<0.0001Grade 3-4 complications were seen in eight patients, of whom seven were in the radiotherapy group. |
| Locoregional recurrenceActuarial 15-year locoregional recurrence rate | long term-updatemedian follow-up 13.3 yearsCreutzberg 2011 | 6% at 15 y | 15.5% at 15 y | P<0.0001Most locoregional recurrences in the no-further-treatment group were vaginal (11.0% of the 15.5%). |
| OS15-year overall survival | long term-updatemedian follow-up 13.3 yearsCreutzberg 2011 | 52% at 15 y | 60% at 15 y | P=0.14 |
| FFSFailure-free survival at 15 years | long term-updatemedian follow-up 13.3 yearsCreutzberg 2011 | 50% at 15 y | 54% at 15 y | P=0.94 |
| Endpoint | Analysis | Pelvic radiotherapy | No further treatment | Effect |
|---|---|---|---|---|
| Locoregional recurrenceActuarial 5-year locoregional recurrence rate | primarymedian follow-up 52 monthsCreutzberg 2000 | 4% at 5 y | 14% at 5 y | P<0.001714 of the 715 randomised patients could be evaluated. |
| OSActuarial 5-year overall survival | primarymedian follow-up 52 monthsCreutzberg 2000 | 81% at 5 y | 85% at 5 y | P=0.31 |
| Treatment-related complicationsEvaluable patients (714)Proportion of patients with treatment-related complications of any grade; two-thirds were grade 1 and grade 3-4 complications occurred in 2% of the radiotherapy group | primaryCreutzberg 2000 | 25% | 6% | P<0.0001Grade 3-4 complications were seen in eight patients, of whom seven were in the radiotherapy group. |
| Locoregional recurrenceActuarial 15-year locoregional recurrence rate | long term-updatemedian follow-up 13.3 yearsCreutzberg 2011 | 6% at 15 y | 15.5% at 15 y | P<0.0001Most locoregional recurrences in the no-further-treatment group were vaginal (11.0% of the 15.5%). |
| OS15-year overall survival | long term-updatemedian follow-up 13.3 yearsCreutzberg 2011 | 52% at 15 y | 60% at 15 y | P=0.14 |
| FFSFailure-free survival at 15 years | long term-updatemedian follow-up 13.3 yearsCreutzberg 2011 | 50% at 15 y | 54% at 15 y | P=0.94 |
Appears in
Sources
Creutzberg CL, van Putten WL, Koper PC, Lybeert ML, Jobsen JJ, Wárlám-Rodenhuis CC, 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.
Creutzberg CL, Nout RA, Lybeert ML, Wárlám-Rodenhuis CC, Jobsen JJ, Mens JW, et al. Fifteen-year radiotherapy outcomes of the randomized PORTEC-1 trial for endometrial carcinoma. Int J Radiat Oncol Biol Phys. 2011;81(4):e631-8.