Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study
Fábio Cardoso Borges,
Filipa Alves da Costa,
Adriana Ramos,
Catarina Ramos,
Catarina Bernardo,
Cláudia Brito,
Alexandra Mayer-da-Silva,
Cláudia Furtado,
Arlindo R. Ferreira,
Diogo Martins-Branco,
Ana Miranda,
António Lourenço
Affiliations
Fábio Cardoso Borges
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal; Corresponding author. Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Filipa Alves da Costa
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal; Department of Pharmacy, Pharmacology and Health Technologies, Faculty of Pharmacy, University of Lisbon (FFULisboa), Avenida Prof. Gama Pinto, 1649-003, Lisboa, Portugal
Adriana Ramos
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Catarina Ramos
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Catarina Bernardo
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Cláudia Brito
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Alexandra Mayer-da-Silva
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Cláudia Furtado
Health Technology Assessment Department, Autoridade Nacional Do Medicamento e Produtos de Saúde (INFARMED), Parque da Saúde de Lisboa, Avenida Do Brasil, 53, 1749-004, Lisboa, Portugal
Arlindo R. Ferreira
Breast Unit, Champalimaud Clinical Centre, Champalimaud Foundation, Avenida Brasília, 1400-038, Lisboa, Portugal
Diogo Martins-Branco
Academic Trials Promoting Team, Institute Jules Bordet, Rue Meylemeersch 90, 1070, Bruxelles, Belgium; Oncology Department, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
Ana Miranda
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal
António Lourenço
National Cancer Registry and Epidemiology Research Unit, Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE, Rua Professor Lima Basto, 1099-023, Lisboa, Portugal; NOVA Medical School, Universidade Nova de Lisboa, Campo Mártires da Pátria 130, 1169-056, Lisboa, Portugal
Background: Real-world (RW) data may provide valuable information on the effectiveness and safety of medicines, which is particularly relevant for clinicians, patients and third-party payers. Evidence on the effectiveness of palbociclib plus fulvestrant is scarce, which highlights the need of additional studies. The aim of this study was to evaluate the effectiveness of palbociclib plus fulvestrant in advanced breast cancer (ABC). Materials and methods: We conducted a population-based retrospective cohort study and cases of interest were identified through the Portuguese National Cancer Registry database and additional data sources. Patients aged≥18 years, diagnosed with ABC and exposed to palbociclib plus fulvestrant between May 31, 2017 and March 31, 2019 were included. Patients were followed-up until death or cut-off date (February 28, 2021). Primary outcome was rw-progression-free survival (rwPFS). Secondary outcomes were rw-overall survival (rwOS), rw-time to palbociclib failure (rwTPF) and rw-time to next treatment (rwTTNT). Results: A total of 210 patients were included. Median age was 58 years (range 29–83) and 99.05% were female. Median follow-up time was 23.22 months and, at cut-off date, treatment had been discontinued in 189 patients, mainly due to disease progression (n = 152). Median rwPFS was 7.43 months (95% confidence interval [CI] 6.28–9.05) and 2-year rwPFS was 16.65% (95%CI 11.97–22.00). Median rwOS was 24.70 months (95%CI 21.58–29.27), median rwTPF was 7.5 months (95%CI 6.51–9.08) and median rwTTNT was 11.74 months (95%CI 10.33–14.08). Conclusion: Palbociclib plus fulvestrant seems an effective treatment for ABC in real-world context. Compared to registrations studies, rwPFS and rwOS were shorter in real-life setting.
