Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03)

帕博西利布 医学 乳腺癌 内科学 肿瘤科 危险系数 佐剂 癌症 人口 临床终点 辅助治疗 妇科
作者
Michael Gnant,Amylou C. Dueck,Sophie Frantal,Miguel Martin,Harold J. Burstein,Richard Greil,Peter Fox,Antonio C. Wolff,Arlene Chan,Eric P. Winer,Georg Pfeiler,Kathy D. Miller,Marco Colleoni,Jennifer M. Suga,Gábor Rubovszky,Judith M Bliss,Ingrid A. Mayer,Christian F. Singer,Zbigniew Nowecki,Olwen Hahn,Jacqui Thomson,Norman Wolmark,Kepa Amillano,Hope S. Rugo,Guenther G. Steger,Blanca Hernando Fernández de Aránguiz,Tufia C. Haddad,Antonia Perelló,Meritxell Bellet,Hannes Fohler,Otto Metzger Filho,Anita Jallitsch-Halper,Kadine Solomon,Céline Schurmans,Kathy Puyana Theall,D. Lu,Kathleen Tenner,Christian Fesl,Angela DeMichele,Erica L. Mayer
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
被引量:11
标识
DOI:10.1200/jco.21.02554
摘要

PURPOSE Palbociclib is a cyclin-dependent kinase 4 and 6 inhibitor approved for advanced breast cancer. In the adjuvant setting, the potential value of adding palbociclib to endocrine therapy for hormone receptor–positive breast cancer has not been confirmed. PATIENTS AND METHODS In the prospective, randomized, phase III PALLAS trial, patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative early breast cancer were randomly assigned to receive 2 years of palbociclib (125 mg orally once daily, days 1-21 of a 28-day cycle) with adjuvant endocrine therapy or adjuvant endocrine therapy alone (for at least 5 years). The primary end point of the study was invasive disease-free survival (iDFS); secondary end points were invasive breast cancer–free survival, distant recurrence-free survival, locoregional cancer-free survival, and overall survival. RESULTS Among 5,796 patients enrolled at 406 centers in 21 countries worldwide over 3 years, 5,761 were included in the intention-to-treat population. At the final protocol-defined analysis, at a median follow-up of 31 months, iDFS events occurred in 253 of 2,884 (8.8%) patients who received palbociclib plus endocrine therapy and in 263 of 2,877 (9.1%) patients who received endocrine therapy alone, with similar results between the two treatment groups (iDFS at 4 years: 84.2% v 84.5%; hazard ratio, 0.96; CI, 0.81 to 1.14; P = .65). No significant differences were observed for secondary time-to-event end points, and subgroup analyses did not show any differences by subgroup. There were no new safety signals for palbociclib in this trial. CONCLUSION At this final analysis of the PALLAS trial, the addition of adjuvant palbociclib to standard endocrine therapy did not improve outcomes over endocrine therapy alone in patients with early hormone receptor–positive breast cancer.
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