Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node-positive, and hormone-receptor positive, early breast cancer patients: 7-year follow-up results of French Adjuvant Study Group 06 randomised trial.
BACKGROUND
The purpose of this study was to determine optimal adjuvant therapy between complete hormonal blockade in premenopausal patients with hormone receptor positive breast cancer and one to three positive nodes.


METHODS
We randomised 333 patients to receive either LHRH agonist (triptorelin 3.75 mg i.m., monthly) plus tamoxifen 30 mg/day for 3 years (TAM-LHRHa, n=164), or fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 21 days for six cycles, without any hormonal treatment (FEC50, n=169).


RESULTS
The 7-year disease-free survival (DFS) was 76% with TAM-LHRHa, and 72% with FEC50 (P=0.13). The 7-year overall survival (OS) was 91% and 88%, respectively (P=0.20). The multivariate analysis confirmed that both treatments were not different for DFS and OS (P=0.83 and P=0.41, respectively). Amenorrhoea occurred in 64% of patients treated with FEC50; it was temporary in 58% of cases after hormonotherapy and in 31% after chemotherapy.


CONCLUSIONS
In intermediate-risk breast cancer, complete hormonal blockade and chemotherapy provided similar outcomes. Hormonal treatment is an alternative to chemotherapy in hormone-sensitive patients, considering the preference of patients in terms of quality of life.
Roché
H
H
Institut Claudius Régaud, Toulouse, France. roche@icr.fnclcc.fr
Kerbrat
P
P
Bonneterre
J
J
Fargeot
P
P
Fumoleau
P
P
Monnier
A
A
Clavère
P
P
Goudier
M-J
MJ
Chollet
P
P
Guastalla
J-P
JP
Serin
D
D
D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000627:therapeutic use; D018572:Disease-Free Survival; D015251:Epirubicin / Q000627:therapeutic use*; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D008197:Lymph Node Excision; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced; D017697:Premenopause / Q000187:drug effects; D011987:Receptors, Steroid / Q000032:analysis; D013629:Tamoxifen / Q000627:therapeutic use; D017329:Triptorelin Pamoate / Q000627:therapeutic use
D004965:Estrogen Antagonists; D011987:Receptors, Steroid; D017329:Triptorelin Pamoate; D013629:Tamoxifen; D007987:Gonadotropin-Releasing Hormone; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil