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 50mg/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 [95% 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.