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Gustavo Viani: EUROPA Trial, A win for patient-centered care in radiation oncology

Gustavo Viani/onconews.com.br

Dec 15, 2024, 10:04

Gustavo Viani: EUROPA Trial, A win for patient-centered care in radiation oncology

Gustavo Viani, Professor of Radiation Oncology at Ribeirão Preto Medical School, University of Sao Paulo, shared a post on LinkedIn:

“EUROPA Trial: Radiology shows increased HRQOL and decreased side effects vs. endocrine therapy in women 70+ with early-stage breast cancer. A win for patient-centered care in radiation oncology.

Objective:

• Compare radiology and endocrine therapy (ET) as single-modality treatments for women aged ≥70 with luminal A-like breast cancer.
• Assess effects on health-related quality of life (HRQOL) and ipsilateral breast tumor recurrence (IBTR).

Methods:

• Study Design: Non-inferiority, phase 3, randomized trial at 18 centers (Italy and Slovenia).
• Women aged ≥70 with stage I, luminal A-like breast cancer, post breast-conserving surgery, ECOG status 0–1.
• Randomization: 1:1 to (whole/partial breast, 5–15 fractions) or ET (aromatase inhibitors/tamoxifen for 5–10 years).

Endpoints:

• Change in HRQOL (GHS scale) at 24 months, 5-year IBTR (not reported here).
• Interim analysis: At least 152 patients completed the 24-month HRQOL assessment.
• Safety analysis included those who received at least one dose of intervention.

Results:

• 731 207 interim analysis (: 104, ET: 103).
• Baseline GHS: radiology group: 71.9 (SD 19.1), ET group: 75.5 (19.3).
• HRQOL at 24 Months:
• Radiology group: Mean change –3.40 (95% CI –7.82 to 1.03; p=0.13).
• ET group: Mean change –9.79 (–14.45 to –5.13; p<0.0001).
• Adjusted mean difference: 6.39 (0.14 to 12.65; p=0.045) favoring RT.
• Adverse Events (AEs):
• Radiology group: 65 (67%) patients; fewer treatment-related AEs.
• ET group: 76 (85%) patients.
• Common grade 3–4 AEs in ET group: Arthralgia (7%), pelvic organ prolapse (3%), fatigue, hot flashes, myalgia, bone pain, fractures (2%).
• Serious AEs: Similar between groups (15% RT, 15% ET).
• Mortality: No treatment-related deaths.”

Gustavo Viani: EUROPA Trial, A win for patient-centered care in radiation oncology