A Randomized Phase 2 Study Exploring the Role of Bevacizumab and a Chemotherapy-Free Approach in HER2-Positive Metastatic Breast Cancer: The HAT Study (BOOG 2008-2003), a Dutch Breast Cancer Research Group Trial

作者：Drooger Jan C^*; van Tinteren Harm; de Groot Steffen M; ten Tije Albert J; de Graaf Hiltje; Portielje Johanneke E A; Jager Agnes; Honkoop Aafke; Linn Sabine C; Kroep Judith R; Erdkamp Frans L G; Hamberg Paul; Imholz Alex L T; van Rossum Schornagel Quirine C; Heijns Joan B; van Leeuwen Stok A Elise; Sleijfer Stefan

来源：Cancer, 2016, 122(19): 2961-2970.

DOI：10.1002/cncr.30141

• bevacizumab
• human epidermal growth factor receptor 2
• metastatic breast cancer
• paclitaxel
• trastuzumab

BACKGROUND: To explore the role of bevacizumab and a chemotherapy-free approach, the authors evaluated the combination of bevacizumab, trastuzumab, and paclitaxel (HAT) and the regimen of trastuzumab and bevacizumab (HA) with the addition of paclitaxel after progression (HA-HAT) as first-line treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. METHODS: In a noncomparative phase 2 trial, patients were randomized between HAT and HA-HAT. The primary endpoint was the progression-free rate at 1 year (1-year PFR). In the HA-HAT group, progression-free survival (PFS) was separately established for HA (PFS1) and HAT (PFS2). RESULTS: Eighty-four patients received HAT (n = 39) or HA-HAT (n = 45). The 1-year PFR was 74.4% (95% confidence interval [CI], 61.8%-89.4%) and 62.2% (95% CI, 49.6%-89.4%) in the HAT and HA-HAT arms, respectively. The median PFS was 19.8 months (95% CI, 14.9-25.6 months) in the HAT arm and 19.6 months (95% CI, 12.0-32.0 months) in the HA-HAT arm. In the HA-HAT arm, the median PFS1 was 10.4 months (95% CI, 6.2-15.0 months), and the median PFS2 was 8.2 months (95% CI, 7.0-12.6 months). The number and severity of adverse events were comparable between the arms. CONCLUSIONS: Both HAT and HA-HAT have promising activity in patients with HER2-positive metastatic breast cancer. In particular, starting with only targeted agents and delaying chemotherapy is worth further exploration.

• 出版日期2016-10-1