Projects / Strategies for the next years
Projects
Two new studies for patients with MDS have been approved by the EORTC Executive Committee. EORTC 06102 trial: Randomized Phase III Study to compare the efficacy and safety of Vidaza versus best supportive care (BSC) in low- and intermediate-1 risk MDS patients: a study of the LG - German MDS Study Group. Recently, the use of hypomethylating agents, such as vidaza or decitabine, has emerged as a possible new treatment option for patients with MDS. These drugs induce the re-expression of previously silenced genes that are relevant for cell growth, differentiation, and apoptotic processes, thus providing a rationale for an epigenetic therapy in MDS. Recent data have demonstrated that vidaza is the first agent to induce a significant survival advantage compared with conventional care regimens in patients with high risk MDS in a large, international, randomized, phase III trial (AZA-001). The proposed study will include all these patients with unmet medical need in order to answer the question of efficacy, safety, and quality of life of vidaza versus BSC in low /int-1 risk MDS patients.
EORTC 06101 trial: A Randomized Phase III Study of vorinostat (MK-0683) in combination with vidaza versus vidaza alone in patients with Intermediate-2 or high risk MDS or high risk Chronic Myelomonocytic Leukemia (CMML). Hypomethylating agents and histone deacetylase (HDAC) inhibitors have each, as single drugs, demonstrated clinical responses in patients with MDS. Vorinostat, when combined with vidaza, may enhance clinical activity with less toxicity than other alternative regimens such as intensive antileukemic chemotherapy or allogeneic stem cell transplantation.
Strategies
Platforms for special population
The LG together with the EORTC Headquarters team is developing a strategic platform for elderly AML with participation of the Cancer in the Elderly Task Force and the Infectious Disease Group. The objectives are to better assess the fitness for treatment and quality of life in this poor risk population by developing a better understanding of the disease biology and designing adaptive strategies for using innovative agents. The platform will also include strategies for supportive care and a registry to explore the feasibility of reduced intensity conditioning for bone marrow transplant in subsets of the elderly population.