Trastuzumab for patients with axillary-node-positive breast cancer : results of the FNCLCC-PACS 04 trial
(2009) Journal of Clinical Oncology — Vol. 27, n° 36, p. 6129-6134 (2009)
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- PURPOSE: 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). 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. CONCLUSION: 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.
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Spielmann, M., Roché, H., Delozier, T., Canon, J.-L., Romieu, G., Bourgeois, H., Extra, J.-M., Serin, D., Kerbrat, P., Machiels, J.-P., Lortholary, A., Orfeuvre, H., Campone, M., Hardy-Bessard, A.-C., Coudert, B., Maerevoet, M., Piot, G., Kramar, A., Martin, A.-L., & Penault-Llorca, F. (2009). Trastuzumab for patients with axillary-node-positive breast cancer : results of the FNCLCC-PACS 04 trial. Journal of Clinical Oncology, 27(36), 6129-6134. https://doi.org/10.1200/JCO.2009.23.0946 (Original work published 2009)