Journal Article
. 2019 Jun; 177(1):115-125.
doi: 10.1007/s10549-019-05296-8.

Phase III evaluating the addition of fulvestrant (F) to anastrozole (A) as adjuvant therapy in postmenopausal women with hormone receptor-positive HER2-negative (HR+/HER2-) early breast cancer (EBC): results from the GEICAM/2006-10 study

Manuel Ruíz-Borrego 1 Angel Guerrero-Zotano 2 Begoña Bermejo 3 Manuel Ramos 4 Josefina Cruz 5 Jose Manuel Baena-Cañada 6 Beatriz Cirauqui 7 Álvaro Rodríguez-Lescure 8 Emilio Alba 9 Noelia Martínez-Jáñez 10 Montserrat Muñoz 11 Silvia Antolín 12 Isabel Álvarez 13 Sonia Del Barco 14 Elena Sevillano 15 José Ignacio Chacón 16 Antonio Antón 17 María José Escudero 18 Victoria Ruiz 18 Eva Carrasco 18 Miguel Martín 19 GEICAM  
Affiliations
  • PMID: 31152327
  •     1 citations

Abstract

Purpose: GEICAM/2006-10 compared anastrozole (A) versus fulvestrant plus anastrozole (A + F) to test the hypothesis of whether a complete oestrogen blockade is superior to aromatase inhibitors alone in breast cancer patients receiving hormone adjuvant therapy.

Methods: Multicenter, open label, phase III study. HR+/HER2- EBC postmenopausal patients were randomized 1:1 to adjuvant A (5 years [year]) or A + F (A plus F 250 mg/4 weeks for 3 year followed by 2 year of A). Stratification factors: prior chemotherapy (yes/no); number of positive lymph nodes (0/1-3/≥ 4); HR status (both positive/one positive) and site.

Primary Objective: disease-free survival (DFS). Planned sample size: 2852 patients.

Results: The study has an early stop due to the financer decision with 870 patients (437 randomized to A and 433 to A + F). Patient characteristics were well balanced. After a median follow-up of 6.24y and 111 DFS events (62 in A and 49 in A + F) the Hazard Ratio for DFS (combination vs. anastrozole) was 0.84 (95% CI 0.58-1.22; p = 0.352). The proportion of patients disease-free in arms A and A + F at 5 year and 7 year were 90.8% versus 91% and 83.6% versus 86.7%, respectively. Most relevant G2-4 toxicities (≥ 5% in either arm) with A versus A + F were joint pain (14.7%; 13.7%), fatigue (2.5%; 7.2%), bone pain (3%; 6.5%), hot flushes (3.5%; 5%) and muscle pain (2.8%; 5.1%).

Conclusions: The GEICAM/2006-10 study did not show a statistically significant increase in DFS by adding adjuvant F to A, though no firm conclusions can be drawn because of the limited sample size due to the early stop of the trial. ClinicalTrials.gov: NCT00543127.

Keywords: Anastrozole; Early breast cancer; Fulvestrant; HR+/HER2−; Luminal.

Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis.
Elizabeth M Salvo, Abril Oliva Ramirez, +4 authors, Imtiaz A Samjoo.
Breast, 2021 Mar 08; 57. PMID: 33677313    Free PMC article.
Systematic Review.