Real-world study of patients with HR+/ HER2-metastatic breast cancer treated with palbociclib and fulvestrant

被引:0
作者
Robert, Nicholas [1 ]
Chen, Connie [2 ]
Doan, Justin [2 ]
Venkatasetty, Divea [1 ]
Espirito, Janet L. [1 ]
Aguilar, Kathleen M. [1 ]
机构
[1] Ontada, Real World Res, C-O Ontada 33 Arch St,20th Floor, Boston, MA 02109 USA
[2] Pfizer, Breast Canc & Precis Med, New York, NY USA
关键词
Community oncology; electronic health records; fulvestrant; metastatic breast cancer; palbociclib; real-world clinical outcomes; retrospective; treatment patterns; PATIENTS RECEIVING PALBOCICLIB; TREATMENT PATTERNS; AROMATASE INHIBITOR; ENDOCRINE THERAPY; FDA APPROVAL; COMBINATION; PLUS; LETROZOLE; OUTCOMES;
D O I
10.1080/14796694.2024.2442302
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
AimsTo investigate real-world treatment patterns and outcomes among patients with hormone receptor-positive/human epidermal growth factor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who initiated first-line palbociclib-fulvestrant.Patients & MethodsRetrospective observational study of iKnowMed electronic health records among patients who initiated first-line palbociclib-fulvestrant between 1 February 2016 and 31 December 2019 and were followed through 30 June 2020. Demographic, clinical, and treatment characteristics were evaluated descriptively. Endpoints including real-world progression-free survival, overall survival, time to chemotherapy, real-world duration of therapy, and time to next treatment were assessed using Kaplan-Meier methods from first-line treatment initiation.Results317 patients were included (median age 67.3 years, 90.5% post-menopausal, 36.9% bone-only disease, 15.9 months median follow-up). Among those with prior adjuvant treatment (n = 269), 66.2% (n = 178) had disease-free intervals less than 12 months. Median real-world progression-free survival was 19.6 months (95% CI 15.2-23.6).ConclusionsThese results suggest favorable real-world clinical outcomes associated with first-line palbociclib-fulvestrant among patients with HR+/HER2- mBC. (clinical trial registration: NCT04498481).
引用
收藏
页码:83 / 94
页数:12
相关论文
共 28 条
[1]   GEICAM/2014-12 (FLIPPER) study: First analysis from a randomized phase II trial of fulvestrant (F)/palbociclib (P) versus (vs) F/placebo (PL) as first-line therapy in postmenopausal women with HR (hormone receptor)+/HER2-endocrine sensitive advanced breast cancer (ABC) [J].
Albanell, J. ;
Martinez, M. T. M. ;
Ramos, M. ;
O'Connor, M. ;
De la Cruz-Merino, L. ;
Santaballa Bertran, A. ;
Martinez-Janez, N. ;
Moreno, F. ;
Fernandez Perez, I. ;
Alarcon Company, J. ;
Virizuela Echaburu, J. A. ;
De la Haba Rodriguez, J. ;
Sanchez-Rovira, P. ;
Gonzalez-Cortijo, L. ;
Margeli Vila, M. ;
Sanchez Munoz, A. ;
Garau Llinas, I. ;
Casas, M. ;
Bezares Montes, S. ;
Rojo Todo, F. .
ANNALS OF ONCOLOGY, 2020, 31 :S1151-S1151
[2]   Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study [J].
Beachler, Daniel C. ;
de Luise, Cynthia ;
Jamal-Allial, Aziza ;
Yin, Ruihua ;
Taylor, Devon H. ;
Suzuki, Ayako ;
Lewis, James H. ;
Freston, James W. ;
Lanes, Stephan .
BMC CANCER, 2021, 21 (01)
[3]   FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer [J].
Beaver, Julia A. ;
Amiri-Kordestani, Laleh ;
Charlab, Rosane ;
Chen, Wei ;
Palmby, Todd ;
Tilley, Amy ;
Zirkelbach, Jeanne Fourie ;
Yu, Jingyu ;
Liu, Qi ;
Zhao, Liang ;
Crich, Joyce ;
Chen, Xiao Hong ;
Hughes, Minerva ;
Bloomquist, Erik ;
Tang, Shenghui ;
Sridhara, Rajeshwari ;
Kluetz, Paul G. ;
Kim, Geoffrey ;
Ibrahim, Amna ;
Pazdur, Richard ;
Cortazar, Patricia .
CLINICAL CANCER RESEARCH, 2015, 21 (21) :4760-4766
[4]   Demographic Characteristics and Treatment Patterns Among Patients Receiving Palbociclib for HR+/HER2-Advanced Breast Cancer: A Nationwide Real-World Experience [J].
Boer, Katalin ;
Rubovszky, Gabor ;
Rokszin, Gyorgy ;
Abonyi-Toth, Zsolt ;
Foldesi, Csenge ;
Dank, Magdolna .
ONCOTARGETS AND THERAPY, 2021, 14 :3971-3981
[5]   Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study [J].
Borges, Fabio Cardoso ;
da Costa, Filipa Alves ;
Ramos, Adriana ;
Ramos, Catarina ;
Bernardo, Catarina ;
Brito, Claudia ;
Mayer-da-Silva, Alexandra ;
Furtado, Claudia ;
Ferreira, Arlindo R. ;
Martins-Branco, Diogo ;
Miranda, Ana ;
Lourenco, Antonio .
BREAST, 2022, 62 :135-143
[6]   Overall survival (OS) with palbociclib (PAL) plus fulvestrant (FUL) in women with hormone receptor-positive (HR plus ), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): Updated analyses from PALOMA-3. [J].
Cristofanilli, Massimo ;
Rugo, Hope S. ;
Im, Seock-Ah ;
Slamon, Dennis J. ;
Harbeck, Nadia ;
Bondarenko, Igor ;
Masuda, Norikazu ;
Colleoni, Marco ;
DeMichele, Angela ;
Iwata, Sherene Loi Hiroji ;
O'Leary, Ben ;
Bananis, Eustratios ;
Liu, Yuan ;
Huang, Xin ;
Kim, Sindy ;
Lechuga, Mariajose ;
Turner, Nicholas C. .
JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (15)
[7]   Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [J].
Cristofanilli, Massimo ;
Turner, Nicholas C. ;
Bondarenko, Igor ;
Ro, Jungsil ;
Im, Seock-Ah ;
Masuda, Norikazu ;
Colleoni, Marco ;
DeMichele, Angela ;
Loi, Sherene ;
Verma, Sunil ;
Iwata, Hiroji ;
Harbeck, Nadia ;
Zhang, Ke ;
Theall, Kathy Puyana ;
Jiang, Yuqiu ;
Bartlett, Cynthia Huang ;
Koehler, Maria ;
Slamon, Dennis .
LANCET ONCOLOGY, 2016, 17 (04) :425-439
[8]   Effectiveness and Safety of Palbociclib plus Endocrine Therapy in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: Real-World Results [J].
Fernandez-Cuerva, Cristina ;
Valencia, Juan Carlos del Rio ;
Tamayo Bermejo, Rocio .
CANADIAN JOURNAL OF HOSPITAL PHARMACY, 2022, 75 (01) :26-33
[9]   Palbociclib and Letrozole in Advanced Breast Cancer [J].
Finn, Richard S. ;
Martin, Miguel ;
Rugo, Hope S. ;
Jones, Stephen ;
Im, Seock-Ah ;
Gelmon, Karen ;
Harbeck, Nadia ;
Lipatov, Oleg N. ;
Walshe, Janice M. ;
Moulder, Stacy ;
Gauthier, Eric ;
Lu, Dongrui R. ;
Randolph, Sophia ;
Dieras, Veronique ;
Slamon, Dennis J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (20) :1925-1936
[10]   The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study [J].
Finn, Richard S. ;
Crown, John P. ;
Lang, Istvan ;
Boer, Katalin ;
Bondarenko, Igor M. ;
Kulyk, Sergey O. ;
Ettl, Johannes ;
Patel, Ravindranath ;
Pinter, Tamas ;
Schmidt, Marcus ;
Shparyk, Yaroslav ;
Thummala, Anu R. ;
Voytko, Nataliya L. ;
Fowst, Camilla ;
Huang, Xin ;
Kim, Sindy T. ;
Randolph, Sophia ;
Slamon, Dennis J. .
LANCET ONCOLOGY, 2015, 16 (01) :25-35