Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer: the Penelope-B trial
PURPOSE - - About one third of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy (NACT) will relapse. Thus, additional therapy is needed. Palbociclib is a cyclin-dependent kinase...
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
April 1, 2021
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| In: |
Journal of clinical oncology
Year: 2021, Jahrgang: 39, Heft: 14, Pages: 1518-1530 |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.20.03639 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.20.03639 Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.20.03639 
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| Verfasserangaben: | Sibylle Loibl; Frederik Marmé; Miguel Martin; Michael Untch; Hervé Bonnefoi; Sung-Bae Kim; Harry Bear; Nicole McCarthy; Mireia Melé Olivé; Karen Gelmon; José García-Sáenz; Catherine M. Kelly; Toralf Reimer; Masakazu Toi; Hope S. Rugo; Carsten Denkert; Michael Gnant; Andreas Makris; Maria Koehler; Cynthia Huang-Bartelett; Maria Jose Lechuga Frean; Marco Colleoni; Gustavo Werutsky; Sabine Seiler; Nicole Burchardi; Valentina Nekljudova; and Gunter von Minckwitz |
| Zusammenfassung: | PURPOSE - - About one third of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy (NACT) will relapse. Thus, additional therapy is needed. Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor demonstrating efficacy in the metastatic setting. - - PATIENTS AND METHODS - - PENELOPE-B (NCT01864746) is a double-blind, placebo‐controlled, phase III study in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative primary breast cancer without a pathological complete response after taxane‐containing NACT and at high risk of relapse (clinical pathological staging-estrogen receptor grading score ≥ 3 or 2 and ypN+). Patients were randomly assigned (1:1) to receive 13 cycles of palbociclib 125 mg once daily or placebo on days 1-21 in a 28-day cycle in addition to endocrine therapy (ET). Primary end point is invasive disease-free survival (iDFS). Final analysis was planned after 290 iDFS events with a two-sided efficacy boundary P < .0463 because of two interim analyses. - - RESULTS - - One thousand two hundred fifty patients were randomly assigned. The median age was 49.0 years (range, 19-79), and the majority were ypN+ with Ki-67 ≤ 15%; 59.4% of patients had a clinical pathological staging-estrogen receptor grading score ≥ 3. 50.1% received aromatase inhibitor, and 33% of premenopausal women received a luteinizing hormone releasing hormone analog in addition to either tamoxifen or an aromatase inhibitor. After a median follow-up of 42.8 months (92% complete), 308 events were confirmed. Palbociclib did not improve iDFS versus placebo added to ET-stratified hazard ratio, 0.93 (95% repeated CI, 0.74 to 1.17) and two-sided weighted log-rank test (Cui, Hung, and Wang) P = .525. There was no difference among the subgroups. Most common related serious adverse events were infections and vascular disorders in 113 (9.1%) patients with no difference between the treatment arms. Eight fatal serious adverse events (two palbociclib and six placebo) were reported. - - CONCLUSION - - Palbociclib for 1 year in addition to ET did not improve iDFS in women with residual invasive disease after NACT. |
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| Beschreibung: | 13 gezählte Seiten, 11 ungezählte Seiten (Supplement) Gesehen am 29.09.2021 |
| Beschreibung: | Online Resource |
| ISSN: | 1527-7755 |
| DOI: | 10.1200/JCO.20.03639 |