1. Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03).
- Author
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Steger, Guenther, Hernando Fernández de Aránguiz, Blanca, Haddad, Tufia, Perelló, Antonia, Bellet, Meritxell, Fohler, Hannes, Metzger Filho, Otto, Jallitsch-Halper, Anita, Solomon, Kadine, Schurmans, Céline, Theall, Kathy, Lu, Dongrui, Tenner, Kathleen, Fesl, Christian, DeMichele, Angela, Mayer, Erica, Gnant, Michael, Dueck, Amylou, Frantal, Sophie, Martin, Miguel, Burstein, Hal, Greil, Richard, Fox, Peter, Wolff, Antonio, Chan, Arlene, Winer, Eric, Pfeiler, Georg, Miller, Kathy, Colleoni, Marco, Suga, Jennifer, Rubovsky, Gabor, Bliss, Judith, Mayer, Ingrid, Singer, Christian, Nowecki, Zbigniew, Hahn, Olwen, Thomson, Jacqui, Wolmark, Norman, Amillano, Kepa, and Rugo, Hope
- Subjects
Antineoplastic Agents ,Hormonal ,Antineoplastic Combined Chemotherapy Protocols ,Breast Neoplasms ,Chemotherapy ,Adjuvant ,Disease Progression ,Disease-Free Survival ,Female ,Humans ,Mastectomy ,Middle Aged ,Neoadjuvant Therapy ,Neoplasm Staging ,Piperazines ,Progression-Free Survival ,Prospective Studies ,Protein Kinase Inhibitors ,Pyridines ,Time Factors - Abstract
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.
- Published
- 2022