Randomised phase II trial of docetaxel and sunitinib in patients with metastatic gastric cancer who were previously treated with fluoropyrimidine and platinum

Background:

Docetaxel is widely used as a chemotherapeutic agent for gastric cancer treatment. Acombined regimen with sunitinib demonstrated a synergistic antitumour effect in apreclinical model. The aim of this study was to evaluate the efficacy and safety of thiscombination in patients with unresectable or metastatic advanced gastric cancerfollowing failure of treatment with a fluoropyrimidine and platinum combination.

Methods:

This open-label, phase II, randomised trial enrolled patients with unresectable ormetastatic gastric cancer. Patients were assigned to either a docetaxel monotherapy arm(D only arm: 60 mg m⁻², every 3 weeks) or a combinationarm (DS arm: docetaxel+sunitinib 37.5 mg every day). The primary end pointof the study was time to progression and the secondary end points were overall responserate, disease control rate, overall survival, and toxicity profile. A pharmacokineticstudy was also performed.

Results:

A total of 107 patients were entered into the study. The TTP was not significantlyprolonged in the DS arm when compared with the D only arm (DS vs D only arm:3.9 months (95% confidence interval (CI) 2.9–4.9) vs 2.6 months(95% CI 1.8–3.5) (P=0.206). The hazard ratio for TTP was0.77 (95% CI 0.52–1.16). However, the objective response rate wassignificantly higher in the DS arm (41.1% vs 14.3%,P=0.002). Patients in the DS arm experienced stomatitis, diarrhoea, andhand–foot syndrome more frequently.

Conclusion:

The addition of sunitinib to docetaxel did not significantly prolong TTP, although itsignificantly increased response.