PORTEC-1
Trial question
What is the role of external beam pelvic radiotherapy in patients with endometrial carcinoma?
Study design
Multi-center
Open label
RCT
Population
714 female patients.
Inclusion criteria: women with stage IC grade 1-2 or stage IB grade 2-3 endometrial carcinoma after surgery.
Key exclusion criteria: history of invasive cancer, except for basal cell carcinoma of the skin; receipt of chemotherapy; receipt of hormonal therapy; receipt of radiotherapy; interval of > 8 weeks between surgery and radiotherapy.
Interventions
N=354 radiotherapy (external beam pelvic radiotherapy with a total dose of 46 Gy in 2 Gy daily fractions).
N=360 no radiotherapy (no additional treatment after surgery).
Primary outcome
Locoregional recurrence at 15 years
5.8%
15.5%
15.5 %
11.6 %
7.8 %
3.9 %
0.0 %
Radiotherapy
No
radiotherapy
Significant
increase ▲
NNH = 10
Significant increase in locoregional recurrence at 15 years (5.8% vs. 15.5%; HR 3.46, 95% CI 1.93 to 6.18).
Secondary outcomes
No significant difference in overall survival at 15 years (52% vs. 60%; ARD -8, 95% CI -18.62 to 2.62).
No significant difference in failure-free survival at 15 years (50% vs. 54%; ARD -4, 95% CI -99.23 to 91.23).
No significant difference in distant metastases at 15 years (9% vs. 7%; AD 2%, 95% CI -1.39 to 5.39).
Safety outcomes
No significant difference in second primary cancers.
Conclusion
In women with stage IC grade 1-2 or stage IB grade 2-3 endometrial carcinoma after surgery, radiotherapy was superior to no radiotherapy with respect to locoregional recurrence at 15 years.
Reference
Carien L Creutzberg, Remi A Nout, Marnix L M Lybeert et al. Fifteen-year radiotherapy outcomes of the randomized PORTEC-1 trial for endometrial carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e631-8.
Open reference URL