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SHR Neuro Cancer Cardio Lipid Metab Microb
Mayer, EL; Hlauschek, D; Gnant, M; O'Brien, PJ; Bellet-Ezquerra, M; Goetz, MP; Ruiz-Borrego, M; Chan, A; Clifton, K; Egle, D; Lake, D; Cabrera, P; Mamounas, T; Pristauz-Telsnigg, G; Dayao, Z; Gil, Gil, M; Cameron, D; Traina, T; Morris, PG; Sabanathan, D; Rinnerthaler, G; Meisel, J; Prat, A; Wolff, AC; Tseng, LM; Isaacs, C; Singer, CF; Rubovszky, G; Foukakis, T; Jassem, J; Winer, EP; Vetter, M; Federmann, J; Metzger, O; Schurmans, C; Gauthier, E; Lu, DR; Fesl, C; Dueck, A; DeMichele, A.
Palbociclib with adjuvant endocrine therapy in early breast cancer: five-year follow up analysis of the global multicenter, open-label, randomized phase III PALLAS trial (ABCSG-42/AFT-05/PrE0109/BIG-14-13).
Ann Oncol. 2025;
Doi: 10.1016/j.annonc.2025.10.003
PubMed
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FullText_MUG
- Co-authors Med Uni Graz
- Pristauz-Telsnigg Gunda
- Rinnerthaler Gabriel
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- Abstract:
- BACKGROUND: In the phase III PALLAS trial, the addition of two years of palbociclib to adjuvant endocrine therapy (ET) did not improve short-term invasive disease-free survival (iDFS) compared with ET alone in high-risk early-stage hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer. Here we report five-year efficacy outcomes, including updated iDFS and overall survival (OS). PATIENTS AND METHODS: PALLAS is an international, open-label, randomized phase III trial evaluating the addition of two years of palbociclib to adjuvant ET in patients with stage II-III HR+/HER2- breast cancer. The primary endpoint was iDFS. RESULTS: The trial enrolled 5,753 patients, with 2,883 randomized to receive palbociclib plus ET and 2,870 to receive ET alone. With a median follow-up of 59.8 months, the 5-year iDFS was 84.2% (95% CI: 82.7%-85.6%) in the palbociclib plus ET arm and 82.4% (95% CI: 80.8%-83.9%) in the ET alone arm (HR: 0.88, 95% CI: 0.77-1.01; log-rank p = 0.0614). No significant iDFS benefit of palbociclib was observed in any subgroup, including analyses by anatomic stage, T-stage, N-stage, tumor grade, prior neo/adjuvant chemotherapy, age, or clinical risk. The 5-year OS was 92.6% (95% CI: 91.5%-93.6%) in the palbociclib plus ET arm and 93.2% (95% CI: 92.1%-94.1%) in the ET alone arm (HR: 1.09, 95% CI: 0.89-1.33; log-rank p = 0.4051). More patients in the ET alone arm (65.7%) than in the palbociclib plus ET arm (33.0%) received CDK4/6 inhibitors post-recurrence. Conversely, more patients in the palbociclib plus ET arm (52.5%) than in the ET alone arm (41.0%) received chemotherapy post-recurrence. CONCLUSIONS: In conclusion, five-year follow-up from the PALLAS trial confirms initially reported results. These long-term findings will provide investigators with important benchmarks for clinical outcomes in the contemporary management of HR+/HER2- breast cancer, and may be further used to guide adjuvant therapy for patients with high-risk early-stage HR+/HER2- breast cancer.