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Proffered Paper - Breast cancer, early stage

LBA12 - PALLAS: A randomized phase III trial of adjuvant palbociclib with endocrine therapy versus endocrine therapy alone for HR+/HER2- early breast cancer

Date

20 Sep 2020

Session

Proffered Paper - Breast cancer, early stage

Presenters

Erica Mayer

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

E.L. Mayer1, M.I. Gnant2, A. DeMichele3, M. Martin4, H. Burstein1, A. Prat5, G. Rubovszky6, K.D. Miller7, G. Pfeiler2, E.P. Winer1, N. Zdenkowski8, D. Anderson9, Z. Nowecki10, S. Loibl11, H. Fohler12, O. Metzger1, D. Fumagalli13, K. Puyana Theall14, C. Fesl15, A. Dueck16

Author affiliations

  • 1 Breast Oncology Center, Dana Farber Cancer Institute, 02215 - Boston/US
  • 2 Comprehensive Cancer Center, Medical University of Vienna, Vienna/AT
  • 3 Medical Oncology, University of Pennsylvania-Perelman Center for Advanced Medicine, 19104 - Philadelphia/US
  • 4 Departamento De Medicina, Instituto de Investigación Sanitaria Gregorio Marañón Universidad Complutense, 28009 - Madrid/ES
  • 5 Medical Oncology Department, Hospital Clinic, University of Barcelona, 8036 - Barcelona/ES
  • 6 Department Of Medical Oncology And Clinical Pharmacology, National Institute of Oncology, 1122 - Budapest/HU
  • 7 Department Of Medicine Hematology/oncology Division, Indiana University School of Medicine, Indianapolis/US
  • 8 The Breast And Endocrine Center, Lake Macquarie Private Hospital, 2290 - Gateshead/AU
  • 9 Medical Oncology Department, Regions Hospital Cancer Care Center, St Paul/US
  • 10 Oncology Centre, Instytut im. Marii-Sklodowskiej, 02-781 - Warsaw/PL
  • 11 Department Of Medicine And Research, German Breast Group, GBG Forschungs GmbH, 63263 - Neu-Isenburg/DE
  • 12 Trial Office, Austrian Breast and Colorectal Cancer Study Group, Vienna/AT
  • 13 Institut Jules Bordet, BIG Against Breast Cancer, Brussels/BE
  • 14 Oncology Clinical Development, Pfizer Inc, Cambridge/US
  • 15 Department Of Statistics, ABCSG - Austrian Breast Cancer Study Group, 1190 - Vienna/AT
  • 16 Department Of Biostatistics, Mayo Clinic, Scottsdale/US
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Resources

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Abstract LBA12

Background

Palbociclib (P) added to endocrine therapy (ET) improves progression-free survival in hormone receptor positive (HR+)/HER-2 negative (HER2-) metastatic breast cancer. The global PALLAS trial (NCT02513394) was designed to determine if the addition of two years of P to adjuvant ET improves invasive disease-free survival (iDFS) over ET alone in patients (pts) with HR+/HER2- early-stage breast cancer.

Methods

In this phase III open-label trial, pts with stage II-III HR+/HER2- breast cancer were randomized to receive either 2 years of P with adjuvant ET, or ET alone. Eligible pts were within 12 months of diagnosis and 6 months of initiating adjuvant ET. The primary objective was to compare invasive disease-free survival (iDFS) between arms; secondary objectives include other recurrence endpoints and safety, as well as quality of life, adherence, and translational science. The study had 85% power to detect a 25% improvement in iDFS (0.75 hazard ratio [HR]). Interim analyses (IA) were predefined in the protocol; IA2 was triggered when 67% of events were observed.

Results

5,760 pts (median age 52 years) were randomized and included in the analysis; 1,013 (17.6%) had stage IIA disease and 4,729 (82.1%) stages IIB/III. 4,754 (82.5%) had received prior chemotherapy. At IA2, after a median follow-up of 23.7 months (351 events), iDFS was similar between the two arms, with 3-year iDFS of 88.2% for P and ET, and 88.5% for ET alone (HR 0.93, 95% confidence interval 0.76-1.15), crossing a pre-specified futility boundary. No benefit from P was observed within clinicopathologic subgroups. Grade 3 or 4 neutropenia was more common with P (61.3% vs 0.4%) but febrile neutropenia was uncommon (1.0%). Other all-grade toxicities occurring more often with P included leukopenia, fatigue, thrombocytopenia, anemia, upper respiratory tract infection, and alopecia. 42.2% of pts discontinued P prior to the planned 2 year duration, primarily due to adverse events.

Conclusions

Within the PALLAS trial, at IA2, two years of adjuvant palbociclib with ET did not improve iDFS compared to ET alone. Ongoing long-term follow-up and additional clinical and translational analyses will explore the effect of P in this patient population.

Clinical trial identification

NCT02513394.

Editorial acknowledgement

Legal entity responsible for the study

Alliance Foundation Trials, LLC; Austrian Breast and Colorectal Cancer Study Group (ABCSG).

Funding

Pfizer, Inc.

Disclosure

E.L. Mayer: Advisory/Consultancy, Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Myriad; Research grant/Funding (institution): Roche/Genentech. M.I. Gnant: Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Celgene; Travel/Accommodation/Expenses: Lilly; Travel/Accommodation/Expenses: Invectys; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Puma; Travel/Accommodation/Expenses: NanoString; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Medison; Travel/Accommodation/Expenses: Lifebrain; Spouse/Financial dependant: Sandoz. A. DeMichele: Honoraria (self), Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Menarini; Advisory/Consultancy: Context Therapeutics; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Calithera. M. Martin: Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): Puma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Amgen; Advisory/Consultancy: Taiho Oncology; Honoraria (self), Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: PharmaMar; Honoraria (self), Advisory/Consultancy: Lilly; Advisory/Consultancy: Daiichi-Sankyo; Honoraria (self), Advisory/Consultancy: Pfizer. A. Prat: Honoraria (self), Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Honoraria (self): BMS; Honoraria (self), Research grant/Funding (institution): Daiichi-Sankyo; Advisory/Consultancy: Puma; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: MSD; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Honoraria (self), Research grant/Funding (institution): Nanostring Technologies; Research grant/Funding (institution): Boehringer; Research grant/Funding (institution): Sysmex Europa GmbH; Research grant/Funding (institution): Medica Scientia Inno Research; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Astellas Pharma. G. Rubovszky: Honoraria (self), Advisory/Consultancy: Pfizer. G. Pfeiler: Advisory/Consultancy: Amgen; Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy: Pfizer; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD. E.P. Winer: Advisory/Consultancy: Carrick; Advisory/Consultancy: Jounce; Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution): Roche/Genentech; Advisory/Consultancy: GSK; Advisory/Consultancy, Officer/Board of Directors: Leap; Advisory/Consultancy: InfiniteMD; Advisory/Consultancy: Gi Theraputics; Advisory/Consultancy: Genomic Health; Advisory/Consultancy: Novartis; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Syros. Z. Nowecki: Honoraria (self): Samsung; Honoraria (self): Roche. S. Loibl: Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy: Seattle Genetics; Honoraria (institution): PriME/Medscape; Honoraria (self): Chugai; Research grant/Funding (institution): Teva; Research grant/Funding (institution): Vifor; Honoraria (institution), Research grant/Funding (institution): Daiichi-Sankyo; Advisory/Consultancy: Lilly; Advisory/Consultancy: Samsung; Advisory/Consultancy: Eirgenix; Advisory/Consultancy: BMS; Advisory/Consultancy: Puma; Honoraria (institution): MSD; Honoraria (institution): Immunomedics; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca. O. Metzger: Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Breast Cancer Research Foundation; Research grant/Funding (institution): Cascadian Therapeutics; Research grant/Funding (institution): Eisai; Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Roche/Genentech; Research grant/Funding (institution): Komen for the Cure; Advisory/Consultancy: G1 Therapeutics; Advisory/Consultancy, Travel/Accommodation/Expenses: Group Oncoclinicas. D. Fumagalli: Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Roche/Genentech; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Tesaro. K. Puyana Theall: Shareholder/Stockholder/Stock options, Full/Part-time employment: Pfizer. All other authors have declared no conflicts of interest.

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