PORTEC-2
Trial question
Is vaginal brachytherapy superior to pelvic radiotherapy in patients with high-intermediate risk endometrial carcinoma?
Study design
Multi-center
Open label
RCT
Population
427 female patients.
Inclusion criteria: female patients with high-intermediate risk endometrial cancer.
Key exclusion criteria: serous or clear cell carcinoma; staging lymphadenectomy; > 8 weeks interval between surgery and radiotherapy; history of previous malignancy; previous radiotherapy, hormonal or chemotherapy; Crohn's disease or ulcerative colitis.
Interventions
N=213 vaginal brachytherapy (total dose of 21 Gy in 3 fractions of 7 Gy, with an interval of 1 week).
N=214 pelvic EBRT (total dose of 46 Gy in 2 Gy daily fractions, five times per week).
Primary outcome
Vaginal recurrence at 10 years
3.4%
2.4%
3.4 %
2.5 %
1.7 %
0.8 %
0.0 %
Vaginal
brachytherapy
Pelvic external beam
radiotherapy
No significant
difference ↔
No significant difference in vaginal recurrence at 10 years (3.4% vs. 2.4%; HR 1.42, 95% CI 0.45 to 4.46).
Secondary outcomes
Significant increase in pelvic recurrence at 10 years (6.3% vs. 0.9%; HR 6.65, 95% CI 1.5 to 29.48).
No significant difference in distant metastases at 10 years (10.4% vs. 8.9%; HR 1.25, 95% CI 0.67 to 2.33).
No significant difference in overall survival at 10 years (69.5% vs. 67.6%; HR 0.94, 95% CI 0.67 to 1.32).
Conclusion
In female patients with high-intermediate risk endometrial cancer, vaginal brachytherapy was not superior to pelvic EBRT with respect to vaginal recurrence at 10 years.
Reference
B G Wortman, C L Creutzberg, H Putter et al. Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy. Br J Cancer. 2018 Oct;119(9):1067-1074.
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