Trastuzumab for Patients With Axillary-Node–Positive Breast Cancer: Results of the FNCLCC-PACS 04 Trial

Journal of Clinical Oncology, 20 Décembre 2009, vol. 27 n°36, 6129-6134

Marc Spielmann, Henri Roché, Thierry Delozier, Jean-Luc Canon, Gilles Romieu, Hugues Bourgeois, Jean-Marc Extra, Daniel Serin, Pierre Kerbrat, Jean-Pascal Machiels, Alain Lortholary, Hubert Orfeuvre, Mario Campone, Anne-Claire Hardy-Bessard, Bruno Coudert, Marie Maerevoet, Gilles Piot, Andrew Kramar, Anne-Laure Martin, and Fre´de´rique Penault-Llorca


To evaluate the efficacy of trastuzumab in patients with node-positive breast cancer treated with
surgery, adjuvant chemotherapy, radiotherapy, and hormone therapy if applicable.

Patients and 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).


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.


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.

More informations