Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
DeMichele, A; Dueck, AC; Hlauschek, D; Martin, M; Burstein, H; Pfeiler, G; Zdenkowski, N; Wolff, A; Bellet-Ezquerra, M; Winer, E; Balic, M; Miller, K; Colleoni, M; Lake, D; Rubovsky, G; Cameron, D; Balko, J; Singer, CF; Nowecki, Z; Iwata, H; Wolmark, N; Parraga, KA; Rugo, H; Steger, GG; Traina, T; Werutsky, G; Czajkowska, D; Metzger, O; El-Abed, S; Theall, KP; Lu, RD; O'Brien, P; Fesl, C; Mayer, E; Gnant, M.
Outcomes in stage IIA versus stage IIB/III in the PALLAS trial [ABCSG-42/AFT-05/PrE0109/BIG-14-13]).
Breast Cancer Res. 2025; 27(1):12
Doi: 10.1186/s13058-024-01941-3
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- Co-Autor*innen der Med Uni Graz
- Balic Marija
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- Abstract:
- BACKGROUND: The PALLAS trial investigated the addition of palbociclib to standard adjuvant endocrine therapy to reduce breast cancer recurrence. This pre-specified analysis was conducted to determine whether adjuvant palbociclib benefited patients diagnosed with lower risk stage IIA disease compared to those with higher stage disease. METHODS: PALLAS was an international, multicenter, randomized, open-label, phase III trial, representing a public-private partnership between Pfizer, the Austrian Breast Cancer Study Group, and the U.S. ALLIANCE Foundation. Patients diagnosed with stage II-III, hormone-receptor-positive, HER2/neu negative breast cancer within 12 months of diagnosis had completed all definitive therapy aside from endocrine therapy (started within 6 months prior to study entry) were eligible. All patients were required to submit a formalin-fixed paraffin-embedded (FFPE) tumor block. Patients were randomly assigned 1:1 to receive standard adjuvant endocrine therapy (of physicians' choice) for at least 5 years with or without 2 years of palbociclib, administered orally at a starting dose of 125 mg daily, given for 21 days followed by a 7-day break. RESULTS: A total of 5,796 patients with HR + /HER2- early breast cancer (including 1,010 with stage IIA) were enrolled. Median follow-up was 50 months for stage IIA patients and 43.1 months overall. In the stage IIA cohort, 4-year iDFS in the palbociclib arm was 92.9% versus 92.1% for ET alone (HR 0.75, 95%CI 0.48-1.19, p = 0.23). There was no differential benefit by histologic grade, chemotherapy receipt, age, or anatomic/clinical risk. Additionally, no benefit to palbociclib was seen in this cohort in invasive breast cancer-free survival (iBCFS), locoregional relapse-free survival (LRFS), distant relapse-free survival (DRFS), or overall survival (OS). For the stage IIB/III patients, 4-year iDFS was 85.3% for palbociclib + ET versus 83.6% for ET alone (HR 0.91, 95% CI 0.77-1.07, p = 0.24). CONCLUSIONS AND RELEVANCE: While there were substantial differences in outcome for stage IIA versus IIB/III patients at 4 years of follow-up, the addition of 2 years of palbociclib did not improve outcomes for patients, regardless of stage. TRIAL REGISTRATION: ClinicalTrials.gov number NCT02513394 Registered 30 Jul 2015.
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