SBW/4Pharma contributed to the final data of the SSG XVIII study which was presented in the plenary session of the American Society of Clinical Oncology (ASCO) 2011 congress – improvement in overall survival. SSG XVIII is a randomised multicentre phase III study comparing three years of treatment with imatinib after surgery in patients with high-risk gastrointestinal stromal tumors (GIST) with one year of treatment. Altogether 400 patients were randomised in Finland, Germany, Norway and Sweden and followed-up for a median time of 54 months. The final results were presented in the plenary session of the American Society of Clinical Oncology (ASCO) congress by professor Heikki Joensuu from Helsinki University Central Hospital. There was a significant difference both in the pre-defined primary endpoint, recurrence-free survival (hazard ratio=0.46 for 3-year vs 1-year treatment, p<0.0001) and overall survival (hazard ratio=0.45, p=0.019). The findings could result in the 3-year course of therapy becoming the new standard of care for the GIST patients who are at risk for relapse. The SBW/4Pharma team contributed by being responsible for the statistical analysis.
SBW/4Pharma is a part of SBW Corporation providing clinical trials data management, biostatistics and medical writing services to drug development companies.
SBW – An integrated CRO for drug discovery and development
