Abstract
Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2- ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole significantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748; P = 0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor-positive (ER+)/HER2- ABC. Here, we present the final overall survival (OS) and updated safety results. Postmenopausal women with ER+/HER2- ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety. A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified hazard ratio for OS was 0.897 (95% CI 0.623-1.294; P = 0.281); median OS in the palbociclib plus letrozole and letrozole alone arms w...Continue Reading
References
Jan 5, 2002·Journal of the National Cancer Institute. Monographs·A H PartridgeE P Winer
Oct 31, 2009·Breast Cancer Research : BCR·Richard S FinnDennis J Slamon
Nov 12, 2009·Journal of the National Cancer Institute·Kristine R Broglio, Donald A Berry
Aug 19, 2014·Expert Review of Pharmacoeconomics & Outcomes Research·Shaloo GuptaGuy Jerusalem
Dec 20, 2014·The Lancet Oncology·Richard S FinnDennis J Slamon
Jun 2, 2015·The New England Journal of Medicine·Nicholas C TurnerUNKNOWN PALOMA3 Study Group
May 25, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hope S RugoHarold J Burstein
Nov 3, 2016·The New England Journal of Medicine·Gabriel N HortobagyiJoyce O'Shaughnessy
Dec 14, 2016·The New England Journal of Medicine·Richard S FinnDennis J Slamon
Jun 6, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·George W SledgeAntonio Llombart-Cussac
Oct 3, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Matthew P GoetzAngelo Di Leo
Apr 28, 2018·Breast Cancer : the Journal of the Japanese Breast Cancer Society·Dorota Kwapisz
May 29, 2018·The Lancet Oncology·Debu TripathyYen-Shen Lu
Jun 5, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Dennis J SlamonGuy Jerusalem
Jul 23, 2018·Journal of the National Cancer Institute·Véronique DiérasRichard S Finn
Sep 13, 2018·CA: a Cancer Journal for Clinicians·Freddie BrayAhmedin Jemal
Oct 23, 2018·The New England Journal of Medicine·Nicholas C TurnerMassimo Cristofanilli
Jan 12, 2019·Breast Cancer Research and Treatment·H S RugoD J Slamon
Jun 6, 2019·The New England Journal of Medicine·Seock-Ah ImDebu Tripathy
Sep 30, 2019·JAMA Oncology·George W SledgeAntonio Llombart-Cussac
Dec 12, 2019·The New England Journal of Medicine·Dennis J SlamonGuy Jerusalem
Dec 1, 2018·Oncology and Therapy·Simon J Johnston, Kwok-Leung Cheung
Citations
Sep 10, 2020·International Journal of Molecular Sciences·Michela PiezzoMichelino De Laurentiis
Sep 10, 2020·International Journal of Molecular Sciences·Michela PiezzoMichelino De Laurentiis
Jan 25, 2021·The Oncologist·Richard S FinnVéronique Diéras
Mar 26, 2021·Breast Cancer Research : BCR·Angela DeMicheleRichard S Finn
Apr 4, 2021·The Breast : Official Journal of the European Society of Mastology·Debora BasileFabio Puglisi
Jun 23, 2021·Bulletin du cancer·Florence CoussyPaul Cottu
Jul 3, 2021·Journal of Personalized Medicine·Vittoria BarberiAlessandra Fabi
Aug 8, 2021·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·E PanagiotouE Kotteas
Sep 7, 2021·Journal of Chemotherapy·Hikmat Abdel-RazeqRayan Bater
Oct 9, 2021·Journal of Cutaneous Pathology·Riyad N H SeervaiJonathan L Curry
Oct 29, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Virginia F Borges
Nov 13, 2021·Journal of Medical Economics·Josh J CarlsonScott D Ramsey