Certara, a provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, announced that its Pharsight Consulting Services has developed a mathematical model of tumour growth inhibition.
The model, when combined with baseline prognostic factors, predicts the treatment effect of bevacizumab – a drug that slows the growth of new blood vessels – for patients with metastatic colorectal cancer.
These results have been published online in the Journal of Clinical Oncology. A copy of the results can be obtained here, together with a commentary by Michael Maitland, assistant professor of medicine in the Section of Haematology/Oncology at the University of Chicago Medicine, Chicago, IL.
Researchers estimated several tumour-size response metrics using longitudinal tumour-size models and data from two Phase III clinical trials, which compared bevacizumab with chemotherapy versus chemotherapy alone as first-line therapy for colorectal cancer.
Trial participants included 923 Western and 203 Chinese patients. Baseline prognostic factors and the tumour-size metric estimates were assessed in multivariate models to predict overall survival. Multiple simulations of the Phase III studies were used to test the models’ predictive capabilities.
René Bruno, Ph.D., managing director of Certara’s Pharsight Consulting Services Europe, and senior author of the paper, said: 'This approach of combining modelling with longitudinal tumour-size data may contribute to improved design and analysis of more informative early-stage clinical studies (Phase Ib, II). It could also enable researchers to select the most promising treatments and reduce the high attrition rate in Phase III oncology studies.'