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

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

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8 Citaten (Scopus)

Samenvatting

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.

Originele taal-2Engels
Pagina's (van-tot)2961-2970
Aantal pagina's10
TijdschriftCancer
Volume122
Nummer van het tijdschrift19
DOI's
StatusGepubliceerd - okt. 2016
Extern gepubliceerdJa

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