Background:Docetaxel is widely used as a chemotherapeutic agent for gastric cancer treatment. A
combined regimen with sunitinib demonstrated a synergistic antitumour effect in a
preclinical model. The aim of this study was to evaluate the efficacy and safety of this
combination in patients with unresectable or metastatic advanced gastric cancer
following failure of treatment with a fluoropyrimidine and platinum combination.Methods:This open-label, phase II, randomised trial enrolled patients with unresectable or
metastatic gastric cancer. Patients were assigned to either a docetaxel monotherapy arm
(D only arm: 60 mg m−2, every 3 weeks) or a combination
arm (DS arm: docetaxel+sunitinib 37.5 mg every day). The primary end point
of the study was time to progression and the secondary end points were overall response
rate, disease control rate, overall survival, and toxicity profile. A pharmacokinetic
study was also performed.Results:A total of 107 patients were entered into the study. The TTP was not significantly
prolonged 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 was
0.77 (95% CI 0.52–1.16). However, the objective response rate was
significantly higher in the DS arm (41.1% vs 14.3%,
P=0.002). Patients in the DS arm experienced stomatitis, diarrhoea, and
hand–foot syndrome more frequently.Conclusion:The addition of sunitinib to docetaxel did not significantly prolong TTP, although it
significantly increased response.
The paper describes transformation rules that map between IDEFO and IDEF3 integration definitions and Petri net modelling constructs. Use of these rules has enabled the development of an enterprise modelling methodology. This methodology ensures that different yet consistent views of business processes and their underpinning resources can be developed by members of a systems engineering team. In particular, the methodology supports the organized capture of functional models, expressed in IDEFO notation, and links them to the subsequent development of behaviour models expressed in IDEF3 notation. Decomposition rules have also been developed that determine relationships between system elements so that they can be modelled at various levels of granularity. Resultant behaviour models can be translated into an equivalent Petri net form. One target application of the modelling rules and methods has been to model interactions between business partners that share common business processes.
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