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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In this article we report the final survival results of the PENELOPE-B trial.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>The study concluded that palbociclib did not significantly improve survival outcomes in the overall population. 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Patients (n = 1250) were randomly assigned to receive either palbociclib 125 mg or placebo d1-21 q4w for 13 cycles in addition to ET.</p><p><strong>Results: </strong>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. 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引用次数: 0
摘要
背景：在PENELOPE-B试验中，与安慰剂相比，在内分泌治疗（ET）中增加1年的帕博西尼并没有提高侵袭性无病生存（iDFS）。在此，我们报告PENELOPE-B试验的最终生存结果。方法：PENELOPE-B试验研究了在紫杉烷为基础的新辅助化疗后伴有残留疾病和高复发风险（ps - eg评分≥3或2和ypN+）的乳腺癌（BC）患者中，激素受体阳性（HR+）、人表皮生长因子受体2阴性（HER2-）患者，在ET中添加1年帕博西尼是否会提高患者的生存率。患者（n=1250）被随机分配接受帕博西尼125 mg或安慰剂d1-21 q4w，持续13个周期，除了et。结果：在中位随访77.8个月后，我们记录了225例死亡(108例帕博西尼；帕博西尼组的6年总生存率（OS）为82.4%，安慰剂组为80.3%[危险度hr0.87, 95% CI 0.67-1.14, p=0.31]。与安慰剂相比，帕博西尼在iDFS、远端无病生存期（DDFS）或局部区域复发率（LRR）方面没有显著改善，即使随访时间更长。在分层分析中，我们发现在主要亚组中没有获益。然而，对小叶BC （LBC）亚组的探索性事后分析显示，帕博西尼的生存率有更好的趋势，OS的HR为0.45 (95% CI 0.19-1.07, p=0.062)， iDFS的HR为0.52 （95% CI 0.28-0.97, p=0.035）。结论：该研究得出帕博西尼没有显著改善总体人群的生存结果。探索性事后分析表明，接受帕博西尼治疗的小叶乳腺癌患者的iDFS结果有更好的趋势。
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-PENELOPE-B.
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.
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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