5-year results of hypofractionated locoregional radiotherapy in early breast cancer HypoG-01 (UNICANCER): a French multicentre, randomised, non-inferiority, phase 3, open-label, controlled trial - Pub
5 days ago
- #radiotherapy
- #breast cancer
- #non-inferiority trial
- Hypofractionated locoregional radiotherapy (40 Gy in 15 fractions over 3 weeks) was compared to standard radiotherapy (50 Gy in 25 fractions over 5 weeks) in early breast cancer patients requiring nodal irradiation.
- The study was a French multicentre, randomised, non-inferiority, phase 3 trial (HypoG-01) involving 1221 patients with a median follow-up of 4.8 years.
- Primary endpoint was ipsilateral arm lymphoedema, with non-inferiority demonstrated for the 3-week regimen (HR 1.02, 95% CI 0.79-1.31).
- 3-year cumulative incidence of arm lymphoedema was similar between groups: 23.4% (3-week) vs 22.2% (5-week).
- Safety profiles were comparable, with grade 3 or worse adverse events occurring in 8% (3-week) and 13% (5-week) of patients.
- The study concluded that the 3-week regimen is non-inferior to the 5-week regimen in terms of lymphoedema risk and late normal tissue effects.
- Funding was provided by the French National Cancer Institute.