Pazopanib and 5-FU/oxaliplatin as first-line treatment in advanced gastric cancer: PaFLO, a randomized phase II study from the AIO (Arbeitsgemeinschaft Internistische Onkologie).

4033 Background: Pazopanib is an oral tyrosine kinase inhibitor which selectively inhibits angiogenesis via VEGFR-1, -2, -3, ckit and PDGF-R. Recent positive trials show that angiogenesis is an effective target in gastric cancer. In this randomized phase II trial we treated patients (pts) with FLO +/- Pazopanib. Methods: Pts with metastatic or locally advanced gastric or gastro-esophageal junction adenocarcinoma, HER2 negative and with measurable disease were randomized in a 2:1 ratio to 5-FU (2,6g/m²/24h, d1) + Leukovorin (200mg/m², d1) + Oxaliplatin (85mg/m², d1) (FLO) + Pazopanib (800mg/d d1-14, q2w) (arm A) or the same chemotherapy without Pazopanib (arm B). Analysis was planned with a Simon Minimax design with PFS rate at 6 month in arm A as the primary endpoint expecting a minimum of 40% of pts progression free. Results: 87 pts were randomized, eligible and evaluable were 51 pts in arm A and 27 in arm B. Pts characteristics in % (arm A/arm B): male: 72/63%, female: 28/37%; median age: 65/60 yrs; ECO...