Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Proffered Paper - Breast cancer, metastatic 2

LBA19 - 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)

Date

21 Sep 2020

Session

Proffered Paper - Breast cancer, metastatic 2

Presenters

Joan Albanell

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

J. Albanell1, M.T.M. Martinez2, M. Ramos2, M. O' Connor3, L. Merino de la Cruz4, A. Santaballa Bertran5, N. Martínez-Jáñez6, F. Moreno7, I. Fernández Pérez8, J. Alarcon Company9, J.A. Virizuela Echaburu10, J. De la Haba Rodríguez11, P. Sánchez-Rovira12, L. González-Cortijo13, M. Margeli Vila14, A. Sánchez Munoz15, I. Garau Llinas16, M. Casas17, S. Bezares Montes18, F. Rojo Todo19

Author affiliations

  • 1 Medical Oncology Department, Hospital del Mar. Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute). CIBERONC ISCIII. GEICAM Spanish Breast Cancer Group, 08003 - Barcelona/ES
  • 2 Oncology, Centro oncológico de Galicia. GEICAM Spanish Breast Cancer Group., 15009 - A Coruna/ES
  • 3 Oncology, University Hospital Waterford. Cancer Trials Ireland., X91 ER8E - Waterford/IE
  • 4 Oncology, 7 Hospital Virgen de la Macarena. GEICAM Spanish Breast Cancer Group., 41009 - Sevilla/ES
  • 5 Oncology, Hospital Universitario y Politécnico de la Fe. GEICAM Spanish Breast Cancer Group., 46026 - Valencia/ES
  • 6 Oncology, Hospital Universitario Ramón y Cajal. GEICAM Spanish Breast Cancer Group., 28034 - Madrid/ES
  • 7 Oncology, Hospital Clínico Universitario San Carlos. GEICAM Spanish Breast Cancer Group., 28040 - Madrid/ES
  • 8 Oncology, Complejo Hospitalario de Vigo Hospital Álvaro Cunqueiro. GEICAM Spanish Breast Cancer Group., 36213 - VIGO/ES
  • 9 Oncology, Hospital Son Espases. GEICAM Spanish Breast Cancer Group., 07010 - Palma de Mallorca/ES
  • 10 Oncology, Hospital Quirón Sagrado Corazón. GEICAM Spanish Breast Cancer Group. SEOM Sociedad Española de Oncología Médica, 41013 - Sevilla/ES
  • 11 Oncology, Hospital Reina Sofía. Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII. GECAM Spanish Breast Cancer Group., 14004 - Córdoba/ES
  • 12 Oncology, Complejo Hospitalario de Jaén. GEICAM Spanish Breast Cancer Group, 23007 - Jaén/ES
  • 13 Oncology, Hospital Universitario Quirosalud. GEICAM Spanish Breast Cancer Group, 28223 - Madrid/ES
  • 14 Oncology, B-ARGO Group, Catalan Institut of Oncology, Hospital Universitari Germans Trias i Pujol. GEICAM Spanish Breast Cancer Group., 08916 - Badalona/ES
  • 15 Oncology, Hospital Universitario Virgen de la Victoria. GEICAM Spanish Breast Cancer Group., 29010 - Málaga/ES
  • 16 Oncology, Hospital Son Llàtzer. GEICAM Spanish Breast Cancer Group., 07198 - Palma de Mallorca/ES
  • 17 Statistical Department, GEICAM Spanish Breast Cancer Group, 28703 - San Sebastian de los Reyes/ES
  • 18 Scientific, GEICAM Spanish Breast Cancer Gropup, 28703 - Madrid/ES
  • 19 Oncology, Hospital Universitario Fundacion Jimenez Diaz. GEICAM Spanish Breas Cancer Group. Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, 28040 - Madrid/ES
More

Resources

Login to access the resources on OncologyPRO.

Abstract LBA19

Background

The role of P combined with F in improving outcomes of endocrine sensitive ABC patients (pts) in the first-line setting deserved clinical testing. To study this, postmenopausal HR+/HER2– ABC with de novo metastatic disease or relapsing after >12 months of completing ≥5 years of adjuvant endocrine therapy were included in FLIPPER study.

Methods

In this double-blind phase II study, pts were randomly assigned in 1:1 ratio to F 500mg/P vs. F/PL. Stratification criteria were: visceral vs. non-visceral and recurrent vs. de novo metastatic disease. The primary objective was progression-free survival (PFS) at 1 year (investigator’s assessment by RECIST 1.1). With a sample size of 190 pts and a two-sided alpha of 0.2, the analysis has 80% power to detect a difference between both treatment groups, assuming PFS proportions of 0.545 and 0.695 for F/PL and F/P, respectively (constant HR of 0.6).

Results

From Feb’2016 to Jan’2019, 189 pts were randomised (94 F/P, 95 F/PL). Median age was 64 years, 45.5% of pts had de novo metastatic disease, 60.3% visceral involvement. The study met the pre-specified primary endpoint: PFS rates at 1-year were 83.5% and 71.9% in F/P and F/PL groups, respectively (HR 0.55; 80% CI 0.36-0.83, p=0.064). Median PFS was 31.8 mo (F/P) vs. 22.0 mo (F/PL) (HR 0.52; 95% CI 0.34-0.78; p=0.002). Overall response rates were 68.3% (F/P) vs. 42.2% (F/PL) (p=0.004). The most frequent G2/4 non-haematological toxicities were diarrhoea (3.2% vs. 2.1%) and fatigue (12.8% vs. 5.3%) with F/P and F/PL, respectively. G3/4 haematological toxicities were neutropenia (64.9% vs. 0%), leukopenia (26.6% vs. 0%) and lymphopenia (14.9% vs. 2.1%). There were no reported cases of febrile neutropenia nor treatment related deaths. OS data are immature.

Conclusions

P/F significantly improved 1-year PFS rate compared to F/PL in pts with HR+/HER2- endocrine sensitive ABC. P/F also improved median PFS and ORR. These data provide evidence for superiority of F/P vs. F/PL in an ABC population not represented in the pivotal PALOMA3 trial.

Clinical trial identification

NCT02690480.

Editorial acknowledgement

Legal entity responsible for the study

GEICAM Spanish Breast Cancer Group.

Funding

AstraZeneca.

Disclosure

J. Albanell: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly. M. Ramos: Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Pfizer. M. O' Connor: Research grant/Funding (institution): HRB grant to UHW Oncology; Full/Part-time employment: University Hospital Waterford. L. De la Cruz-Merino: Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck; Research grant/Funding (institution): Celgene; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: MSD. A. Santaballa Bertran: Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: GSK; Advisory/Consultancy: Clovis; Advisory/Consultancy: Roche; Advisory/Consultancy: Pierre Fabre. F. Moreno: Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): MSD; Honoraria (self): AstraZeneca. I. Fernández Pérez: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Roche; Advisory/Consultancy: Tesaro- MSD. M. Margeli Vila: Advisory/Consultancy: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Kern-Pharma. F. Rojo Todo: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: Genomic Health; Advisory/Consultancy: Guardant Health; Advisory/Consultancy: Archer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pierre Fabre. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings