A phase III trial, HypoG-01, presented at the ESMO conference, reveals that a hypofractionated radiation therapy course consisting of 15 sessions over 3 weeks is equivalent to the standard normofractionated radiation therapy of 25 sessions over 5 weeks for women with locoregional breast cancer. This multicenter, randomized study, conducted across 29 sites in France, is poised to change the global management of breast cancer patients.
HypoG-01 Trial Details
The HypoG-01 trial, sponsored by Unicancer, enrolled 1,265 patients with locoregional breast cancer between September 2016 and March 2020. The mean age of participants was 58 years, and the study included patients with various breast tumor subtypes, such as HER2+, RH-positive, and triple-negative breast cancers. Patients were randomized to either a hypofractionated course (15 sessions over 3 weeks, 40 Gy total, 2.67 Gy per session) or a normofractionated course (25 sessions over 5 weeks, 50 Gy total, 2 Gy per session).
The primary endpoint was the onset of lymphoedema, a common side effect of radiotherapy. Secondary endpoints included locoregional relapse-free survival, relapse-free survival, and overall survival.
Key Findings and Clinical Implications
The study demonstrated that the frequency of lymphoedema onset in the hypofractionated course was not higher than in the standard course. Furthermore, locoregional relapse-free survival, relapse-free survival, and overall survival were similar in both courses. These results indicate that the shorter, more convenient 3-week regimen is equally effective and safe compared to the traditional 5-week regimen.
Dr. Sofia Rivera, a radiotherapist oncologist at Gustave Roussy and the lead investigator of the study, stated, "Our multi-centre, randomised study... demonstrates real progress for patients as the treatment is shorter (3 weeks) and less burdensome but offers the same benefits as the five-week course. Our results set a new standard of radiation therapy treatment in this indication."
Impact on Breast Cancer Treatment
Breast cancer is the most prevalent cancer among women, with a significant proportion diagnosed at a locoregional stage. The standard radiation therapy course has traditionally been spread over five weeks, posing a considerable burden on patients. The HypoG-01 trial provides evidence supporting a shorter, equally effective treatment option, improving patient comfort and potentially reducing healthcare costs.
"All in all, all women with breast cancer will now be able to undergo a shorter course of radiotherapy, with numerous advantages, both for the comfort of patients and for healthcare reimbursement bodies," Dr. Rivera concluded. The study, funded by the French National Cancer Institute, underscores the importance of academic clinical trials in advancing patient care.
