Congress Abstracts 2006

156

IMPROVING CLINICAL AND QUALITY-OF-LIFE OUTCOMES: RESULTS OF A PHASE III TRIAL OF DECITABINE (DAC) VS SUPPORTIVE CARE (SC) IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS). Jan Davis, RN, BS, University of Texas M.D. Anderson Cancer Center, Houston, TX; Hussein Saba, MD, PhD, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; and Carlos De Castro, MD, Duke University Medical Center, Durham, NC.

MDS is a blood disorder that results in ineffective hematopoiesis and peripheral blood cytopenias. Standard therapy includes supportive care (SC) to manage symptoms related to anemia, thrombocytopenia, and/or neutropenia. Hypomethylating agents, including azacytidine (Vidaza^®) and decitabine (Dacogen™), are also emerging as treatment options for MDS.

This presentation will help educate nurses who manage MDS about DAC, a hypomethylating agent that impacts clinical and quality-of-life (QOL) outcomes.

A phase III, randomized, open-label trial was conducted comparing DAC vs SC in MDS patients with intermediate and high-risk disease. Co-primary endpoints were Response Rate (CR+PR) and Time to Acute Myeloid Leukemia (AML) or Death. Secondary endpoints included transfusion requirements and QOL. QOL was measured using the EORTC scale, which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, social); 3 symptom scales (fatigue, pain, nausea & vomiting); and global health and QOL scales.

170 patients received either DAC (3-hr infusion 15 mg/m2/hr q8h for 3 days q6wk) plus SC (n=89) or SC alone (n=81). Baseline characteristics were comparable. The response rate according to International Working Group MDS criteria was 17% for DAC (9% CR, 8% PR) vs 0% for SC (p<0.001). DAC patients had a median Time to AML or Death that was numerically greater than SC patients (12.1 vs 7.8 months). Additionally, 13% of DAC-treated patients had hematologic improvement vs 7% of SC patients. Responses were durable, lasting a median of 10 months. The median number of cycles was 3, although additional cycles may be warranted. The percentage of patients not requiring red blood cell transfusions increased in the DAC group and did not change in the SC group. A lower percentage of patients received erythropoietic growth factors in the DAC arm vs SC arm. Patients receiving DAC showed significant improvement in global health status, physical functioning, fatigue, and dyspnea. DAC was well tolerated; the most common adverse events were myelosuppression and infections.

DAC is a promising therapy for MDS, demonstrating improved clinical and QOL outcomes and a manageable toxicity profile. In a disease where few treatments exist, DAC represents an important option for patients of oncology nurses managing MDS.