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31.05.2019 | Clinical trial | Ausgabe 1/2019

Breast Cancer Research and Treatment 1/2019

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

Zeitschrift:
Breast Cancer Research and Treatment > Ausgabe 1/2019
Autoren:
Manuel Ruíz-Borrego, Angel Guerrero-Zotano, Begoña Bermejo, Manuel Ramos, Josefina Cruz, Jose Manuel Baena-Cañada, Beatriz Cirauqui, Álvaro Rodríguez-Lescure, Emilio Alba, Noelia Martínez-Jáñez, Montserrat Muñoz, Silvia Antolín, Isabel Álvarez, Sonia Del Barco, Elena Sevillano, José Ignacio Chacón, Antonio Antón, María José Escudero, Victoria Ruiz, Eva Carrasco, Miguel Martín, GEICAM
Wichtige Hinweise
Trial results have been presented as a Proffered Paper (Oral) presentation in the European Society for Medical Oncology (ESMO) 2017.
The members of GEICAM participant investigators are listed in “Acknowledgement” section.

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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.

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