BCIRG 006: Docetaxel and trastuzumab-based regimens improve DFS and OS over AC-T in node positive and high risk node negative HER2 positive early breast cancer patients: Quality of life (QOL) at 36 months follow-up

• DOI: 10.1200/jco.2007.25.18_suppl.19647
• Publication Date: 2020-03-06T21:16:25Z
• Authors: N. J. Robert; W. Eiermann; T. Pienkowski; J. Crown; M. Martin; M. Pawlicki; A. Chan; V. Bee; D. Slamon; H. Au
• Keywords: Clinical endpoint; Interim analysis

19647 Background: The primary objective of the BCIRG 006 trial was to determine if use trastuzumab in early high-risk HER2-positive breast cancer significantly improved clinical outcomes. A secondary evaluate QOL patients receiving 2 treatments. Methods: compared adjuvant standard AC (doxorubicin/cyclophosphamide x 4 cycles) followed by docetaxel [AC-T] or trastuzumab-containing regimens, T with 1 year [AC-TH] TCarbo 6 [TCH] node positive negative (n=3222). Results: 2nd planned interim analysis, median follow-up at 36 months, showed that both AC-TH and TCH DFS OS over control (relative reduction risk relapse 39% (P<0.0001) 33% (P=0.0003) respectively, for vs control). Relative death 41% (P=0.0041) 34% (P =0.017) control. Congestive heart failure occurred 0.4% AC-T 1.9% AC-TH. Global safety profile acceptable all 3 arms more favourable than QOL, a endpoint this trial, assessed using EORTC QLQC-30, BR-23, EQ5D. We will present endpoints comparing Physical Function, Health Status, Future Perspectives, Systemic Treatment Effects change scores from baseline mid-chemotherapy, end chemotherapy, 12 months (with 10% considered clinically important). proportion improved/stable/worsened be chi-square tests. Other exploratory analyses presented. [Table: see text]