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Final survival results from the PENELOPE-B trial investigating palbociclib versus placebo for patients with high-risk HR+/HER2-breast cancer and residual disease after neoadjuvant chemotherapy: brief trial updates

Background - The addition of 1 year of palbociclib to endocrine therapy (ET) did not improve invasive disease-free survival (iDFS) compared with placebo in the PENELOPE-B trial. In this article we report the final survival results of the PENELOPE-B trial. - Patients and methods - The PENELOPE-B tria...

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Hauptverfasser: Loibl, Sibylle (VerfasserIn) , Martin, M. (VerfasserIn) , Bonnefoi, H. (VerfasserIn) , Untch, M. (VerfasserIn) , Kim, S. -B. (VerfasserIn) , Bear, H. D. (VerfasserIn) , García-Sáenz, J. A. (VerfasserIn) , Melé Olivé, M. (VerfasserIn) , Mc Carthy, N. (VerfasserIn) , Gelmon, K. (VerfasserIn) , Kelly, C. M. (VerfasserIn) , Im, S. -A. (VerfasserIn) , Reimer, T. (VerfasserIn) , Martinez-Janez, M. (VerfasserIn) , Zhang, Z. (VerfasserIn) , Toi, M. (VerfasserIn) , Provencher, L. (VerfasserIn) , Rugo, H. S. (VerfasserIn) , Gnant, M. (VerfasserIn) , Makris, A. (VerfasserIn) , Antón Torres, A. (VerfasserIn) , Hirmas, N. (VerfasserIn) , Holtschmidt, J. (VerfasserIn) , Nekljudova, V. (VerfasserIn) , Marmé, Frederik (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: July 2025
In: Annals of oncology
Year: 2025, Jahrgang: 36, Heft: 7, Pages: 832-837
ISSN:1569-8041
DOI:10.1016/j.annonc.2025.03.010
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.annonc.2025.03.010
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753425001218
Volltext
Verfasserangaben:S. Loibl, M. Martin, H. Bonnefoi, M. Untch, S.-B. Kim, H.D. Bear, J.A. García-Sáenz, M. Melé Olivé, N. Mc Carthy, K. Gelmon, C.M. Kelly, S.-A. Im, T. Reimer, M. Martinez-Janez, Z. Zhang, M. Toi, L. Provencher, H.S. Rugo, M. Gnant, A. Makris, A. Antón Torres, N. Hirmas, J. Holtschmidt, V. Nekljudova & F. Marmé

MARC

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245 1 0 |a Final survival results from the PENELOPE-B trial investigating palbociclib versus placebo for patients with high-risk HR+/HER2-breast cancer and residual disease after neoadjuvant chemotherapy  |b brief trial updates  |c S. Loibl, M. Martin, H. Bonnefoi, M. Untch, S.-B. Kim, H.D. Bear, J.A. García-Sáenz, M. Melé Olivé, N. Mc Carthy, K. Gelmon, C.M. Kelly, S.-A. Im, T. Reimer, M. Martinez-Janez, Z. Zhang, M. Toi, L. Provencher, H.S. Rugo, M. Gnant, A. Makris, A. Antón Torres, N. Hirmas, J. Holtschmidt, V. Nekljudova & F. Marmé 
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520 |a Background - The addition of 1 year of palbociclib to endocrine therapy (ET) did not improve invasive disease-free survival (iDFS) compared with placebo in the PENELOPE-B trial. In this article we report the final survival results of the PENELOPE-B trial. - Patients and methods - The PENELOPE-B trial investigated whether adding 1 year of palbociclib to ET in hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer (BC) patients with residual disease and high relapse risk (clinical and pathological stage + estrogen receptor status and histological grade score ≥3 or 2 and ypN+) after taxane-based neoadjuvant chemotherapy would improve patient survival. Patients (n = 1250) were randomly assigned to receive either palbociclib 125 mg or placebo d1-21 q4w for 13 cycles in addition to ET. - Results - After a median follow-up of 77.8 months, we recorded 225 deaths (108 palbociclib; 117 placebo) with a 6-year overall survival (OS) rate of 82.4% in the palbociclib arm versus 80.3% in the placebo arm (hazard ratio 0.87, 95% confidence interval (CI) 0.67-1.14, P = 0.31). No significant improvement was noted for palbociclib versus placebo for iDFS, distant disease-free survival or locoregional relapse rate, even with longer follow-up. Upon stratified analysis, we found no benefits across major subgroups. However, exploratory post hoc analyses of the lobular BC (LBC) subgroup indicated a trend toward better survival outcomes in favor of palbociclib (hazard ratio 0.45, 95% CI 0.19-1.07, P = 0.062 for OS and hazard ratio 0.52, 95% CI 0.28-0.97, P = 0.035 for iDFS). - Conclusion - The study concluded that palbociclib did not significantly improve survival outcomes in the overall population. Exploratory post hoc analyses suggested a trend toward better iDFS outcome in patients with LBC receiving palbociclib. 
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