PORTEC-3
Trial question
Is adjuvant chemoradiotherapy superior to radiotherapy in patients with high-risk endometrial cancer?
Study design
Multi-center
Open label
RCT
Population
660 female patients.
Inclusion criteria: female patients with high-risk endometrial cancer.
Key exclusion criteria: uterine sarcoma; previous pelvic radiotherapy, hormonal therapy, or chemotherapy; bulky cervical involvement with radical hysterectomy; IBD; impaired renal or cardiac function.
Interventions
N=330 chemoradiotherapy (radiotherapy plus chemotherapy consisting of two cycles of cisplatin 50 mg/m² given during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m²).
N=330 radiotherapy (48.6 Gy in 1.8 Gy fractions given on 5 days per week).
Primary outcome
Overall survival at 5 years
81.8%
76.7%
81.8 %
61.3 %
40.9 %
20.4 %
0.0 %
Chemoradiotherapy
Radiotherapy
No significant
difference ↔
No significant difference in overall survival at 5 years (81.8% vs. 76.7%; HR 1.32, 95% CI 0.94 to 1.85).
Secondary outcomes
Significant increase in failure-free survival at 5 years (75.5% vs. 68.6%; HR 1.41, 95% CI 1.05 to 1.89).
Significant decrease in pelvic recurrence (4.9% vs. 9.2%; HR 0.51, 95% CI 0.28 to 0.92).
No significant difference in distant metastases (23.1% vs. 29.7%; HR 0.77, 95% CI 0.57 to 1.03).
Safety outcomes
No significant difference in hypertension.
Significant differences in grade 3 or worse adverse events (60% vs. 12%), persistence of grade 2 neuropathy or worse at 3 years (8% vs. 1%).
Conclusion
In female patients with high-risk endometrial cancer, chemoradiotherapy was not superior to radiotherapy with respect to overall survival at 5 years.
Reference
Stephanie M de Boer, Melanie E Powell, Linda Mileshkin et al. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Mar;19(3):295-309.
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