Autologous transplantation gives encouraging results for young adults with favorable-risk acute myeloid leukemia, but is not improved with gemtuzumab ozogamicin

Blood - Tập 117 - Trang 5306-5313 - 2011
Hugo F. Fernandez1, Zhuoxin Sun2, Mark R. Litzow3, Selina M. Luger4, Elisabeth M. Paietta5, Janis Racevskis5, Gordon Dewald3, Rhett P. Ketterling3, Jacob M. Rowe6, Hillard M. Lazarus7, Martin S. Tallman8
1Moffitt Cancer Center and Research Institute, Tampa, FL
2Dana-Farber Cancer Institute, Boston, MA
3Mayo Clinic, Rochester, MN
4University of Pennsylvania, Philadelphia, PA
5Montefiore Medical Center, North Division, Bronx, NY;
6Rambam Medical Center, Haifa, Israel
7University Hospitals Case Medical Center, Cleveland, OH;
8Memorial Sloan Kettering Cancer Center, New York, NY

Tóm tắt

AbstractWe report the results of a prospective, randomized phase 3 trial evaluating the use of gemtuzumab ozogamicin (GO) in an intensive consolidation approach in 657 patients 17-60 years of age. Patients in first complete remission (CR1) after cytarabine and standard- or high-dose daunorubicin induction received 2 cycles of consolidation with high-dose cytarabine followed by peripheral blood progenitor cell collection. The 352 patients who entered consolidation were randomized to receive GO (n = 132) or not (n = 138) and then proceeded to autologous hematopoietic cell transplantation (HCT). GO was given to 67 patients. Median follow-up was 50.9 months. Results of the intention-to-treat analysis demonstrated a 4-year disease-free survival (DFS) of 33.6% versus 35.9% (P = .54) and an overall survival (OS) of 41.3% versus 41.9% (P = .52) for those randomized to receive GO versus no GO, respectively. Patients with favorable- and intermediate-risk acute myeloid leukemia (AML) treated with high-dose daunorubicin and autologous HCT had 4-year DFS rates of 60% and 40% and OS rates of 80% and 49.3%, respectively. For younger AML patients in CR1, autologous HCT should be considered in favorable- and intermediate-cytogenetic risk patients who do not have an allogeneic donor. The addition of a single dose of GO in this setting did not improve outcomes. This trial is registered at http://www.clinicaltrials.gov as NCT00049517.

Tài liệu tham khảo

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Blood

Tập 117

5306-5313

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