TY - JOUR
T1 - A randomized phase 2 study exploring the role of bevacizumab and a chemotherapy-free approach in HER2-positive metastatic breast cancer
T2 - The HAT study (BOOG 2008-2003), a Dutch Breast Cancer Research Group trial
AU - Drooger, Jan C.
AU - van Tinteren, Harm
AU - de Groot, Steffen M.
AU - ten Tije, Albert J.
AU - de Graaf, Hiltje
AU - Portielje, Johanneke E A
AU - Jager, Agnes
AU - Honkoop, Aafke
AU - Linn, Sabine C.
AU - Kroep, Judith R.
AU - Erdkamp, Frans L G
AU - Hamberg, Paul
AU - Imholz, Alex L T
AU - van Rossum-Schornagel, Quirine C.
AU - Heijns, Joan B.
AU - van Leeuwen-Stok, A. Elise
AU - Sleijfer, Stefan
PY - 2016/10
Y1 - 2016/10
N2 - 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.
AB - 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.
KW - Bevacizumab
KW - Human epidermal growth factor receptor 2
KW - Metastatic breast cancer
KW - Paclitaxel
KW - Trastuzumab
UR - http://www.scopus.com/inward/record.url?scp=84993973273&partnerID=8YFLogxK
U2 - 10.1002/cncr.30141
DO - 10.1002/cncr.30141
M3 - Article
C2 - 27315546
AN - SCOPUS:84993973273
SN - 0008-543X
VL - 122
SP - 2961
EP - 2970
JO - Cancer
JF - Cancer
IS - 19
ER -