Treatment of acute myeloid leukemia (AML) in older patients remains challenging. Several host- and disease-related factors contribute to poor outcome in elderly AML patients, including medical comorbidities, physical frailty, and increased incidence of poor-risk biological features (adverse cytogenetics, expression of multidrug resistance proteins, prior myelodysplasia). As a result most elderly patients are not considered suitable for an intensive treatment approach and therefore are treated with best supportive care (BSC) including hydroxyurea or low-dose cytarabine, however outcomes remain dismal.
Building on their long-lasting collaboration, EORTC and GIMEMA Leukemia Groups, partnered with Pfizer, performed a phase III trial evaluating the efficacy and safety profile of Gemtuzumab Ozogamicin (GO, Mylotarg®), an antibody conjugated with a DNA intercalating agent, which specifically targets myeloid cells. These Groups are now reporting the final results of this study in a paper appearing in a recent issue of Journal of Clinical Oncology*. GO improved significantly overall survival as compared to BSC in elderly AML patients ineligible for intensive chemotherapy. Prof Amadori from GIMEMA and EORTC commented: “The findings of this study offer a new treatment option for older AML patients, an unaddressed patient population demonstrating the feasibility of clinical trials in frail patient groups which remain under served. This trial constitutes a landmark in the field of hemato-oncology”.
Dr Baron, chair of the EORTC Leukemia Group pointed: “This achievement highlights the role of academic groups best placed to address specific public health questions. In addition, contribution of the academic sector in positioning new treatments is valued and of specific importance here as GO was prematurely withdrawn from the market in 2010”.
This study coordinated by the EORTC headquarters recruited 237 patients from 35 sites in 3 European countries between 2004 and 2013. This trial was supported by Pfizer Inc., the manufacturer of GO, which was voluntarily withdrawn from the US market in 2010.
The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 2,500 collaborators from all disciplines involved in cancer treatment and research in more than 300 hospitals in over 30 countries. Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices. EORTC Headquarters, a unique pan European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.
Gruppo italiano malattie ematologiche dell’adulto (GIMEMA) Foundation aims at promoting academic clinical research, spreading awareness, disclosing scientific knowledge and organizing training sessions. Since its foundation, more than 30 years ago, GIMEMA has had one objective, that of guaranteeing that all patients receive the same treatment, no matter where they come from. Through a network organization, which also boasts a complex centralized diagnostic tasks, over 150 Italian Hospitals belonging GIMEMA are able to provide patients.
The Central Office of GIMEMA Foundation, based in Rome, obtained in 2002 the UNI EN ISO 9001:2000 certification for the activities of the “Design, implementation and management of clinical trials.” In 2011, the certification was extended to the field of education. The Central Office has in fact, built a sector called “GIMEMA inFormazione”, dealing with the organization of events and professional courses dedicated, to young people who want to venture into the world of clinical trials. Work carried out by GIMEMA has allowed to achieve outstanding scientific results. GIMEMA collaborates with the most important European cooperative groups such as EORTC (European Organisation for Research and Treatment of Cancer), MRC (Medical Research Council, UK), SAL (Study Alliance Leukemia, Germany), and with organizations from the United States such as CALGB (Cancer and Leukemia Group B), as well as with regulatory bodies such as AIFA (Italian Medicines Agency) and EMA (European Medicines Agency).
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