Final Survival Results from the Penelope-B trial investigating palbociclib vs placebo for patients with high-risk HR+/HER2- breast cancer and residual disease after neoadjuvant chemotherapy - PENELOPE-B.
S Loibl, M Martin, H Bonnefoi, M Untch, S Kim, H D Bear, J A García-Sáenz, M M Olivé, N Mc Carthy, K Gelmon, C M Kelly, S-A Im, T Reimer, M-J Noelia, Z Zhang, M Toi, L Provencher, H S Rugo, M Gnant, A Makris, A A Torres, N Hirmas, J Holtschmidt, V Nekljudova, F Marmé
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引用次数: 0
Abstract
Background: The addition of 1-year of palbociclib to endocrine therapy (ET) did not improve invasive disease-free survival (iDFS) compared to placebo in the PENELOPE-B trial. Here we report the final survival results for the PENELOPE-B trial.
Methods: The PENELOPE-B trial investigated whether adding 1 year of palbociclib to ET in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) patients with residual disease and high relapse risk (CPS-EG 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 6-year overall survival (OS) rate of 82.4% in the palbociclib arm vs. 80.3% in the placebo arm [hazard rationHR0.87, 95% CI 0.67-1.14, p=0.31]. No significant improvement was noted for palbociclib vs placebo for iDFS, distant disease-free survival (DDFS) or locoregional relapse rate (LRR), 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 towards better survival outcomes in favour of palbociclib HR of 0.45 (95% CI 0.19-1.07, p=0.062) for OS and 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 towards better iDFS outcome in patients with lobular breast cancer receiving palbociclib.
期刊介绍：
Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine.
The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings.
Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.
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