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

Autores de FISABIO

• Álvaro Rodríguez Lescure

  Autor

Autores ajenos a FISABIO

• Ruiz-Borrego, M
• Guerrero-Zotano, A
• Bermejo, B
• Ramos, M
• Cruz, J
• Baena-Canada, JM
• Cirauqui, B
• Alba, E
• Martinez-Janez, N
• Munoz, M
• Antolin, S
• Alvarez, I
• Del Barco, S
• Sevillano, E
• Chacon, JI
• Anton, A
• Escudero, MJ
• Ruiz, V
• Carrasco, E
• Martin, M
• Segui, MA
• Ayala, F
• de la Haba, J
• Martinez, P
• Gonzalez, S
• Lahuerta, A
• Toral, JC
• de Duenas, EM
• Florian, J
• Godes, MJ
• Llorca, C
• Blancas, I
• Jara, C
• Morales, S
• Arcusa, A
• Martinez, A
• Vicente, E
• de Juan, A
• Rodriguez, M
• Garcia, M
• Garcia, P
• Bayo, JL
• Caranana, V
• Casinello, J
• Jolis, L
• Gil, M
• Canabate, C
• Oltra, A
• Ramirez, J
• Lomas, M
• Barnadas, A
• Sureda, M
• Carabantes, F
• Moreno, I
• Moreno, AL
• GEICAM

Grupos de Investigación

• HOSPITAL GENERAL UNIVERSITARIO DE ELCHE

Abstract

PurposeGEICAM/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.MethodsMulticenter, open label, phase III study. HR+/HER2- EBC postmenopausal patients were randomized 1:1 to adjuvant A (5years [year]) or A+F (A plus F 250mg/4weeks for 3year followed by 2year 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.ResultsThe 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 5year and 7year 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%).ConclusionsThe 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

• HR; HER2-; Early breast cancer; Fulvestrant; Anastrozole; Luminal