Abk�rzung zur Hauptnavigation Abk�rzung zu den Newsmeldungen Abk�rzung zu den Topstories  
  Barrierefreiheit    Kontakt MedUni Wien    Intranet    MedUni Wien - Shop    Universitätsbibliothek    Universitätsklinikum AKH Wien  
 
ccc_logo_en.gif
 
AKH Wien
 
 
Hauptnavigation
  • Livestream 2021
  • Home
  • Über das CCC
    • Allgemeines
    • Leitung der Organisationseinheit
    • CCC-Office Team
    • Kliniken und Partner
    • Qualitätsmanagement
    • Kontakt
  • PatientInnen
    • Covid-19
    • Allgemeines
    • Cancer School
    • Terminvereinbarung
    • Pflegeambulanz
    • PatientInnenvertretung
    • Links
  • Klinischer Bereich
    • Allgemeines
    • CCC Tumorboards
  • Wissenschaft & Forschung
    • Young CCC
    • CCC-ExpertInnenvideos
    • CCC Forschungscluster
    • CCC Units
    • CCC Platforms
    • Translationale Forschung
    • CCC Best Paper Award
    • CCC-TRIO Symposium
    • Kontakt/Links
  • Lehre
    • CCC Cancer School
    • Vienna International Summer School on Clinical and Experimental Oncology - VSSO
    • CCC Excellence Lecture
    • Interdisziplinäre onkologische Ausbildung
    • Klinisch-Praktisches Jahr (KPJ)
    • PhD Programme
    • Postgraduelle Fort- und Weiterbildung
    • Information/Contact
 
 
Subnavigation
    Inhaltsbereich


    Zurück zur Übersicht
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2022 Jan 7. doi: 10.1200/JCO.21.01918
    Treatment Exposure and Discontinuation in the PALbociclib CoLlaborative Adjuvant Study of Palbociclib With Adjuvant Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer (PALLAS/AFT-05/ABCSG-42/BIG-14-03).
    Mayer EL1,  Fesl C2,  Hlauschek D3,  Garcia-Estevez L4,  Burstein HJ5,  Zdenkowski N6,  Wette V7,  Miller KD8,  Balic M9,  Mayer IA10,  Cameron D11,  Winer EP12,  Ponce Lorenzo JJ13,  Lake D14,  Pristauz-Telsnigg G15,  Haddad TC16,  Shepherd L17,  Iwata H18,  Goetz M19,  Cardoso F20,  Traina TA21,  Sabanathan D22,  Breitenstein U23,  Ackerl K24,  Metzger Filho O25,  Zehetner K26,  Solomon K27,  El-Abed S28,  Theall KP29,  Lu DR30,  Dueck A31,  Gnant M32,  DeMichele A33
    Author information
    1Dana-Farber Cancer Institute, Boston, MA.
    2Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.
    3Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.
    4MD Anderson Cancer Center, Madrid, Spain.
    5Dana-Farber Cancer Institute, Boston, MA.
    6The Breast and Endocrine Centre, Gateshead, NSW, Australia.
    7Breast Centre, Sankt Veit an der Glan, Austria.
    8Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN.
    9Medical University Graz, Graz, Austria.
    10Vanderbilt University, Nashville, TN.
    11Cancer Research UK Edinburgh Centre, Edinburgh, United Kingdom.
    12Dana-Farber Cancer Institute, Boston, MA.
    13GEICAM Spanish Breast Cancer Group, Madrid, Spain.
    14Memorial Sloan Kettering Cancer Center, New York, NY.
    15Medical University Graz, Graz, Austria.
    16Mayo Clinic, Rochester, MN.
    17Queen's University, Kingston, Canada.
    18Aichi Cancer Center Hospital, Aichi, Japan.
    19Mayo Clinic, Rochester, MN.
    20Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisboa, Portugal.
    21Hospital General Universitario de Alicante, Alicante, Spain.
    22Lakeside Specialist Breast Clinic and Nepean Cancer Care Centre, Norwest, NSW, Australia.
    23Brust-Zentrum, Zürich, Switzerland.
    24Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.
    25Dana-Farber Cancer Institute, Boston, MA.
    26Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.
    27Alliance Foundation Trials, Boston, MA.
    28Breast International Group, Brussels, Belgium.
    29Pfizer, Inc, Cambridge, MA.
    30Pfizer, Inc, La Jolla, CA.
    31Alliance Statistics and Data Center, Mayo Clinic, Phoenix, AZ.
    32Medical University of Vienna, Vienna, Austria.
    33Penn Medicine, Philadelphia, PA.
    Abstract

    PURPOSE: The PALLAS study investigated whether the addition of palbociclib, an oral CDK4/6 inhibitor, to adjuvant endocrine therapy (ET) improves invasive disease-free survival (iDFS) in early hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In this analysis, we evaluated palbociclib exposure and discontinuation in PALLAS.

    METHODS: Patients with stage II-III HR+, HER2- disease were randomly assigned to 2 years of palbociclib with adjuvant ET versus ET alone. The primary objective was to compare iDFS between arms. Continuous monitoring of toxicity, dose modifications, and early discontinuation was performed. Association of baseline covariates with time to palbociclib reduction and discontinuation was analyzed with multivariable competing risk models. Landmark and inverse probability weighted per-protocol analyses were performed to assess the impact of drug persistence and exposure on iDFS.

    RESULTS: Of the 5,743 patient analysis population (2,840 initiating palbociclib), 1,199 (42.2%) stopped palbociclib before 2 years, the majority (772, 27.2%) for adverse effects, most commonly neutropenia and fatigue. Discontinuation of ET did not differ between arms. Discontinuations for non-protocol-defined reasons were greater in the first 3 months of palbociclib, and in the first calendar year of accrual, and declined over time. No significant relationship was seen between longer palbociclib duration or ≥ 70% exposure intensity and improved iDFS. In the weighted per-protocol analysis, no improvement in iDFS was observed in patients receiving palbociclib versus not (hazard ratio 0.89; 95% CI, 0.72 to 1.11).

    CONCLUSION: Despite observed rates of discontinuation in PALLAS, analyses suggest that the lack of significant iDFS difference between arms was not directly related to inadequate palbociclib exposure. However, the discontinuation rate illustrates the challenge of introducing novel adjuvant treatments, and the need for interventions to improve persistence with oral cancer therapies.


    Publikations ID: 34995105
    Quelle: öffnen
     
    Drucken
     
    ccc_logo_en.gif
    ccc_logo_en.gif
    ccc_logo_en.gif

    Schnellinfo

     
    -- Initiative Krebsforschung / Krebsforschungslauf

    -- Cancer Care
    -- Kliniken und Partner
    -- CCC Cancer School
    -- Young CCC
    -- CCC Tumorboards
    -- CCC Forschungscluster
    -- CCC Units
    -- CCC Platforms
    -- SOPs / Leitlinien
    -- Kontakt
    Zuklappen
     
    Ausklappen
     
     

    Featured

     
     
     
     
     
     
     
     
     
     
     
     
     
    © MedUni Wien |
     Impressum | Nutzungsbedingungen | Kontakt