Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence
Annual rept. 18 Aug 97-17 Aug 98
CANCER THERAPY AND RESEARCH FOUNDATION SAN ANTONIO TX
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Dose intensive anthracycline-based adjuvant regimens improve disease-free survival in breast cancer patients however, recent studies also show an increased risk for development of therapy-related hematologic malignancies. Models of leukemogenesis propose that clonal hematopoiesis may be an early marker of genetic damage, preceding the acquisition of critical, recurring genetic alterations associated with the development of therapy related myelodysplastic syndromes and acute leukemia. The goal of this study is to determine whether dose-intensive adjuvant regimens for breast cancer induce genetic damage to hematopoietic stem cells, defined by the emergence of clonal hematopoiesis in a subset of patients following dose-intensive adjuvant therapy for breast cancer. Clonal hematopoiesis will be evaluated using two different methods, the HUMARA clonality assay based on a methylated X-linked polymorphism and microsatellite instability assays. In year one, the following objectives were completed a activation of the clonal hematopoiesis biological protocol S9719, b introductory protocol presentations at the SWOG Fall 1997 and Spring 1998 meetings, c advertisements mailed to SWOG institutions including revisions of model consent form, d beginning of patient registration, e development of a centralized specimen collectionprocessing repository, f standardization of the HUMARA and microsatellite assays, and g addressing quality control and quality assurance issues.
- Medicine and Medical Research