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Trastuzumab for patients with axillary-node-positive breast cancer: Results of the FNCLL-PACS 04 trial
Journal of Clinical Oncology, 11/24/09

Spielmann M et al. – 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.

• 3010 patients with operable node-positive breast cancer randomly assigned to receive adjuvant anthracycline-based chemotherapy with or without docetaxel
• Patients who presented human epidermal growth factor receptor 2 (HER2) -overexpressing tumors secondary randomly assigned to either sequential regimen of trastuzumab (6 mg/kg every 3 weeks) for 1 year or observation
• Primary end point DFS

  Results
  • Overall 528 patients randomly assigned between trastuzumab (n = 260) and observation (n = 268) arm
  • Of 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 date of analysis (October 2007), 129 DFS events recorded
  • Random assignment to trastuzumab arm was associated with nonsignificant 14% reduction in risk of relapse (hazard ratio, 0.86; 95% CI, 0.61 to 1.22; log-rank stratified on pathologic node involvement)
  
  

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