Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial.
OBJECTIVE
To evaluate the efficacy of trastuzumab in patients with node-positive breast cancer treated with surgery, adjuvant chemotherapy, radiotherapy, and hormone therapy if applicable.


METHODS
Three thousand ten patients with operable node-positive breast cancer were randomly assigned to receive adjuvant anthracycline-based chemotherapy with or without docetaxel. Patients who presented human epidermal growth factor receptor 2 (HER2) -overexpressing tumors were secondary randomly assigned to either a sequential regimen of trastuzumab (6 mg/kg every 3 weeks) for 1 year or observation. The primary end point was disease-free survival (DFS).


RESULTS
Overall 528 patients were randomly assigned between trastuzumab (n = 260) and observation (n = 268) arm. Of the 234 patients (90%) who received at least one administration of trastuzumab, 196 (84%) received at least 6 months of treatment, and 41 (18%) discontinued treatment due to cardiac events (any grade). At the date of analysis (October 2007), 129 DFS events were recorded. Random assignment to the trastuzumab arm was associated with a nonsignificant 14% reduction in the risk of relapse (hazard ratio, 0.86; 95% CI, 0.61 to 1.22; P = .41, log-rank stratified on pathologic node involvement). Three-year DFS rates were 78% (95% CI, 72.3 to 82.5) and 81% (95% CI, 75.3 to 85.4) in the observation and trastuzumab arms, respectively.


CONCLUSIONS
After a 47-month median follow-up, 1 year of trastuzumab given sequentially after adjuvant chemotherapy was not associated with a statistically significant decrease in the risk of relapse.
Spielmann
Marc
M
Institut Gustave Roussy, Département de Médecine, 39, rue Camille Desmoulins, 94908 Villejuif, France. marc.spielmann@igr.fr
Roché
Henri
H
Delozier
Thierry
T
Canon
Jean-Luc
JL
Romieu
Gilles
G
Bourgeois
Hugues
H
Extra
Jean-Marc
JM
Serin
Daniel
D
Kerbrat
Pierre
P
Machiels
Jean-Pascal
JP
Lortholary
Alain
A
Orfeuvre
Hubert
H
Campone
Mario
M
Hardy-Bessard
Anne-Claire
AC
Coudert
Bruno
B
Maerevoet
Marie
M
Piot
Gilles
G
Kramar
Andrew
A
Martin
Anne-Laure
AL
Penault-Llorca
Frédérique
F
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001365:Axilla / Q000473:pathology; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000068878:Trastuzumab; D055815:Young Adult
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D000068878:Trastuzumab; D005472:Fluorouracil