An open-label, multicentre biomarker-oriented AIO phase II trial of sunitinib for patients with chemo-refractory advanced gastric cancer

Background: Sunitinib monotherapy in pretreated patients with advanced gastric cancer (AGC) was investigated. Preplanned analyses of tumour biomarkers on treatment outcome were performed. Patients and methods: Patients received sunitinib 50 mg/day for 4 weeks with 2 weeks rest until disease progression or unacceptable toxicity. The primary end-point was objective response rate (ORR). Secondary end-points included progression-free survival (PFS), overall survival (OS) and safety. Results: Fifty-two patients were enrolled and treated (safety population, SP). In the intention to treat population (n = 51); the ORR was 3.9%, median PFS was 1.28 months 195% CI, 1.18-1.90], median OS was 5.81 months [95% CI, 3.48-12.32], the estimated one-year survival rate was 23.7% [95%CI: 12.8-36.5]. In subgroup analyses, tumour VEGF-C expression compared with no expression was associated with significantly shorter median PFS (1.23 versus 2.86 months, logrank p = 0.0119) but there was no difference in tumour control rate (p = 0.142). In the SP, serious adverse events occurred in 26 patients, leading to 13 deaths, all sunitinib unrelated. Thirty-eight patients died from progressive disease, nine died <60 days after treatment start. Conclusion: Sunitinib monotherapy was associated with limited tumour response and good/moderate tolerability in this setting. (C) 2011 Elsevier Ltd. All rights reserved.