Cited by 235Advanced Breast Cancer TherapiesBreast Cancer Treatment StudiesPARP inhibition in cancer therapy

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

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Gnant, Michael, Dueck, Amylou C., Frantal, Sophie, Martin, Miguel, Burstein, Hal J., Greil, Richard, Fox, Peter, Wolff, Antonio C., Chan, Arlene, Winer, Eric P., Pfeiler, Georg, Miller, Kathy D., Colleoni, Marco, Suga, Jennifer M., Rubovsky, Gabor, Bliss, Judith M., Mayer, Ingrid A., Singer, Christian F., Nowecki, Zbigniew, Hahn, Olwen, Thomson, Jacqui, Wolmark, Norman, Amillano, Kepa, Rugo, Hope S., Steger, Guenther G., Hernando Fernández de Aránguiz, Blanca, Haddad, Tufia C., Perelló, Antonia, Bellet, Meritxell, Fohler, Hannes, Metzger Filho, Otto, Jallitsch-Halper, Anita, Solomon, Kadine, Schurmans, Céline, Theall, Kathy P., Lu, Dongrui R., Tenner, Kathleen, Fesl, Christian, DeMichele, Angela, Mayer, Erica L., on behalf of the PALLAS groups and investigators·2022·Journal of Clinical Oncology

DOI 10.1200/jco.21.02554PMC PMC10476784

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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.

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Authors: Gnant, M., Dueck, A. C., Frantal, S., Martin, M., Burstein, H. J., Greil, R., Fox, P., Wolff, A. C., Chan, A., Winer, E. P., Pfeiler, G., Miller, K. D., Colleoni, M., Suga, J. M., Rubovsky, G., Bliss, J. M., Mayer, I. A., Singer, C. F., Nowecki, Z., Hahn, O., Thomson, J., Wolmark, N., Amillano, K., Rugo, H. S., Steger, G. G., Hernando Fernández de Aránguiz, B., Haddad, T. C., Perelló, A., Bellet, M., Fohler, H., Metzger Filho, O., Jallitsch-Halper, A., Solomon, K., Schurmans, C., Theall, K. P., Lu, D. R., Tenner, K., Fesl, C., DeMichele, A., Mayer, E. L., & on behalf of the PALLAS groups and investigators
Affiliations: Comprehensive Cancer Center Vienna (AT)
Mayo Clinic (US)
Austrian Breast & Colorectal Cancer Study Group (AT)
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Dana-Farber Cancer Institute (US)
Paracelsus Medical University (AT)
Government of New South Wales (AU)
Johns Hopkins University (US)
Curtin University (AU)
Indiana University Health (US)
European Institute of Oncology (IT)
Kaiser Permanente Vallejo Medical Center (US)
National Institute of Oncology, Budapest, Hungary
Institute of Cancer Research (GB)
Vanderbilt University Medical Center (US)
The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
University of Chicago (US)
Peninsula Health (AU)
University of Pittsburgh (US)
Hospital Universitari Sant Joan de Reus (ES)
University of California, San Francisco (US)
GEICAM Spanish Breast Cancer Group, Madrid, Spain
Hospital Universitario Son Espases (ES)
Vall d'Hebron Institute of Oncology (ES)
Alliance Foundation Trials (US)
BIG, Brussels, Belgium
Pfizer (United States) (US)
University of Pennsylvania (US)
GEICAM – Spanish Breast Cancer Group (ES)
ORCID: Gnant, Michael
Dueck, Amylou C.
Martin, Miguel
Greil, Richard
Fox, Peter
Wolff, Antonio C.
Chan, Arlene
Winer, Eric P.
Pfeiler, Georg
Miller, Kathy D.
Colleoni, Marco
Suga, Jennifer M.
Rubovsky, Gabor
Bliss, Judith M.
Mayer, Ingrid A.
Singer, Christian F.
Nowecki, Zbigniew
Thomson, Jacqui
Wolmark, Norman
Amillano, Kepa
Rugo, Hope S.
Steger, Guenther G.
Hernando Fernández de Aránguiz, Blanca
Haddad, Tufia C.
Perelló, Antonia
Bellet, Meritxell
Metzger Filho, Otto
Schurmans, Céline
Lu, Dongrui R.
Tenner, Kathleen
Fesl, Christian
DeMichele, Angela
Mayer, Erica L.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2022-01-20
Volume: 40
Issue: 3
Pages: 282-293
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.21.02554
PMC: PMC10476784
OpenAlex: W4200066800
Cited by: 235
References: 46
Citations by year: 2026: 26 · 2025: 70 · 2024: 56 · 2023: 51 · 2022: 32
FWCI: 22.57
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
IUScholarWorks (Indiana University) (submittedVersion)
eScholarship (California Digital Library) (submittedVersion)
Funders: Pfizer
Cancer Research UK (25351)
National Institute for Health and Care Research (NIHR202432)
National Cancer Institute (U10CA180868, R01CA214893)
Topics: Health Sciences › Medicine › Oncology › Advanced Breast Cancer Therapies
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
Keywords: palbociclib, early breast cancer, hormone receptor-positive breast cancer, HER2-negative breast cancer, adjuvant therapy, endocrine therapy, invasive disease-free survival, PALLAS trial
MeSH terms: Progression-Free Survival, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Mastectomy, Middle Aged, Neoplasm Staging, Piperazines, Prospective Studies, Pyridines, Time Factors, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Antineoplastic Agents, Hormonal, Neoadjuvant Therapy, Protein Kinase Inhibitors

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

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