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. 2022 Apr:62:135-143.
doi: 10.1016/j.breast.2022.02.005. Epub 2022 Feb 8.

Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study

Fábio Cardoso Borges  1 , Filipa Alves da Costa  2 , Adriana Ramos  3 , Catarina Ramos  4 , Catarina Bernardo  5 , Cláudia Brito  6 , Alexandra Mayer-da-Silva  7 , Cláudia Furtado  8 , Arlindo R Ferreira  9 , Diogo Martins-Branco  10 , Ana Miranda  11 , António Lourenço  12
Affiliations

Real-world effectiveness of palbociclib plus fulvestrant in advanced breast cancer: Results from a population-based cohort study

Fábio Cardoso Borges et al. Breast. 2022 Apr.

Abstract

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.

Keywords: Advanced breast cancer; Cancer registries; Effectiveness; Fulvestrant; Palbociclib; Real-world data.

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Conflict of interest statement

We have read the journal's policy and the authors of this manuscript have the following competing interests: ARF reports travel grants from Roche and advisory board fees from Daiichi Sankyo, Gilead, Merck Sharp & Dohme, Novartis and Roche, outside the submitted work. DMB reports travel grants from LEO Farmacêuticos, Merck Sharp & Dohme, Ipsen, Janssen, Roche, and Novartis, advisory board fees from Janssen, Pfizer, Merck Sharp & Dohme, Angelini, AstraZeneca, and Novartis, and institutional grants from F. Hoffmann-La Roche, outside the submitted work. The other authors have declared that no competing interests exist.

Figures

Fig. 1
Fig. 1
Kaplan-Meier estimation on rwPFS (A) and rwOS (B) for patients exposed to palbociclib plus fulvestrant.
Fig. 2
Fig. 2
Kaplan-Meier estimation on rwTPF (A) and rwTTNT (B) for patients exposed to palbociclib plus fulvestrant.
Fig. 3
Fig. 3
Univariate and multivariable analysis for rwPFS. CI, Confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HR, Hazard ratio; NST, No special type; Ref, Reference.
Fig. 4
Fig. 4
Univariate and multivariable analysis for rwOS. CI, Confidence interval; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HR, Hazard ratio; NST, No special type; Ref, Reference.
See this image and copyright information in PMC

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