Adjuvant Palbociclib for Early Breast Cancer: The PALLAS Trial Results (ABCSG-42/AFT-05/BIG-14-03).
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Date
2022-01-20ICR Author
Author
Gnant, M
Dueck, AC
Frantal, S
Martin, M
Burstein, HJ
Greil, R
Fox, P
Wolff, AC
Chan, A
Winer, EP
Pfeiler, G
Miller, KD
Colleoni, M
Suga, JM
Rubovsky, G
Bliss, JM
Mayer, IA
Singer, CF
Nowecki, Z
Hahn, O
Thomson, J
Wolmark, N
Amillano, K
Rugo, HS
Steger, GG
Hernando Fernández de Aránguiz, B
Haddad, TC
Perelló, A
Bellet, M
Fohler, H
Metzger Filho, O
Jallitsch-Halper, A
Solomon, K
Schurmans, C
Theall, KP
Lu, DR
Tenner, K
Fesl, C
DeMichele, A
Mayer, EL
PALLAS groups and investigators,
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
PALLAS groups and investigators
Humans
Breast Neoplasms
Disease Progression
Piperazines
Pyridines
Antineoplastic Agents, Hormonal
Antineoplastic Combined Chemotherapy Protocols
Protein Kinase Inhibitors
Neoplasm Staging
Disease-Free Survival
Chemotherapy, Adjuvant
Neoadjuvant Therapy
Mastectomy
Prospective Studies
Time Factors
Middle Aged
Female
Progression-Free Survival
Research team
Clinical Trials & Statistics Unit
Language
eng
Date accepted
2021-11-04
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022, 40 (3), pp. 282 - 293
Publisher
LIPPINCOTT WILLIAMS & WILKINS