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SHR Neuro Cancer Cardio Lipid Metab Microb

Rinnerthaler, G; Egle, D; Bartsch, R; Schmitt, CA; Petzer, A; Balic, M; Petru, E; Denison, U; Singer, CF; Bjelic-Radisic, V; Gampenrieder, SP; Knauer, M; Sotlar, K; Brunner, C; Posch, F; Hlauschek, D; Sölkner, L; Bago-Horvath, Z; Filipits, M; Gili, M; Ritter, M; Wieser, V; Albertini, C; Zaborsky, N; Weiss, L; Marhold, M; Schneeweiss, B; Pusch, R; Gnant, M; Greil, R.
Neoadjuvant atezolizumab in combination with dual HER2 blockade plus epirubicin in women with early HER2-positive breast cancer: the randomized phase 2 ABCSG-52/ATHENE trial.
Nat Cancer. 2025; Doi: 10.1038/s43018-024-00890-2 [OPEN ACCESS]
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Leading authors Med Uni Graz: Rinnerthaler Gabriel
Co-authors Med Uni Graz: Balic Marija; Bjelic-Radisic Vesna; Petru Edgar; Posch Florian
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Abstract:: The role of anthracyclines in the treatment of early breast cancer (EBC) is increasingly being challenged, especially in de-escalation strategies. However, owing to their immunogenic effects, anthracyclines are promising combination partners with immunotherapies. In the randomized phase 2 trial ABCSG-52 (EudraCT no. 2019-002364-27), we investigated epirubicin plus immunotherapy in women with human epidermal growth factor receptor 2 (HER2)-positive EBC. A total of 58 patients were randomized 1:1 to two cycles of a chemotherapy-free induction phase (part 1) of dual HER2 blockade with trastuzumab and pertuzumab (TP) plus the anti-programmed death ligand 1 antibody atezolizumab (TP-A) or TP alone. Thereafter, all patients received four cycles of TP-A in combination with epirubicin (part 2). The primary endpoint, pathological complete response (pCR), was met in 35 patients (60.3%; 95% confidence interval (CI) 47.5% to 71.9%), 19 patients (65.5%) in the TP-A group and 16 patients (55.2%) in the TP group. The residual cancer burden 0/I rate and objective response rate (secondary endpoints) in all patients with evaluable data were 80.0% (n = 44/55; 95% CI 67.6% to 88.4%) and 89.3% (n = 50/56; 95% CI 78.5% to 95.0%), respectively. Grade ≥3 adverse events were reported in 17 patients (29.3%). Based on our findings, we conclude that a neoadjuvant chemotherapy de-escalation immunotherapy regimen with trastuzumab, pertuzumab, atezolizumab and epirubicin is effective and safe in patients with HER2-positive EBC.