TY - JOUR
T1 - Intensified induction chemotherapy in adult acute myeloid leukemia followed by high-dose chemotherapy and autologous peripheral blood stem cell transplantation
T2 - An eastern cooperative oncology group trial (E4995)
AU - Cassileth, Peter A.
AU - Lee, Sandra J.
AU - Litzow, Mark R.
AU - Miller, Kenneth B.
AU - Stadtmauer, Edward A.
AU - Tallman, Martin S.
AU - Lazarus, Hillard M.
AU - Bennett, John M.
AU - Paietta, Elisabeth
AU - Dewald, Gordon W.
AU - Rowe, Jacob M.
N1 - Funding Information:
This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA13650, CA07190, CA15488, CA17145, CA11083 from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
PY - 2005/1
Y1 - 2005/1
N2 - The feasibility of intensified therapy in adults < 61-years-old with de novo acute myeloid leukemia (AML) was evaluated by adding high-dose cytarabine (HDAC) to conventional induction therapy and in post-remission therapy prior to peripheral blood stem cell transplantation (PBSCT). Patients were treated with conventional induction therapy (daunorubicin days 1 - 3 and cytarabine days 1 - 7), followed by HDAC (2 gm/M2) every 12 h ( × 6) on days 8 - 10. Patients in complete remission (CR) with HLA-matched siblings were assigned to allogeneic PBSCT; the others received two courses of HDAC (3 gm/M2 every 12 h on days 1, 3, and 5) given 1 month apart. Peripheral blood stem cells were then harvested and infused after high-dose chemotherapy. Of 62 eligible, evaluable patients, 47 (76%) achieved CR. The mortality rate was 10% (6 patients); no deaths occurred during the two post-remission courses of HDAC. Fifteen patients were assigned to allogeneic PBSCT and 32 to autologous PBSCT. All surviving patients have been followed for more than 4 years. Including all patients scheduled to receive autoPBSCT in an intent-to-treat analysis, after a median 5-year follow-up the current, non-actuarial, four-year event-free and overall survival was 47% and 47%, respectively. Intensified induction therapy was associated with more toxicity than conventional induction therapy, and the CR rate did not improve. Nevertheless, intensive post-remission therapy was well tolerated, no treatment-related mortality occurred with autologous PBSCT, and disease-free survival and overall survival were lengthy.
AB - The feasibility of intensified therapy in adults < 61-years-old with de novo acute myeloid leukemia (AML) was evaluated by adding high-dose cytarabine (HDAC) to conventional induction therapy and in post-remission therapy prior to peripheral blood stem cell transplantation (PBSCT). Patients were treated with conventional induction therapy (daunorubicin days 1 - 3 and cytarabine days 1 - 7), followed by HDAC (2 gm/M2) every 12 h ( × 6) on days 8 - 10. Patients in complete remission (CR) with HLA-matched siblings were assigned to allogeneic PBSCT; the others received two courses of HDAC (3 gm/M2 every 12 h on days 1, 3, and 5) given 1 month apart. Peripheral blood stem cells were then harvested and infused after high-dose chemotherapy. Of 62 eligible, evaluable patients, 47 (76%) achieved CR. The mortality rate was 10% (6 patients); no deaths occurred during the two post-remission courses of HDAC. Fifteen patients were assigned to allogeneic PBSCT and 32 to autologous PBSCT. All surviving patients have been followed for more than 4 years. Including all patients scheduled to receive autoPBSCT in an intent-to-treat analysis, after a median 5-year follow-up the current, non-actuarial, four-year event-free and overall survival was 47% and 47%, respectively. Intensified induction therapy was associated with more toxicity than conventional induction therapy, and the CR rate did not improve. Nevertheless, intensive post-remission therapy was well tolerated, no treatment-related mortality occurred with autologous PBSCT, and disease-free survival and overall survival were lengthy.
KW - AML
KW - Autologous stem cell transplantation
KW - High-dose cytarabine
KW - Intensive therapy
UR - http://www.scopus.com/inward/record.url?scp=19944430945&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=19944430945&partnerID=8YFLogxK
U2 - 10.1080/10428190412331283288
DO - 10.1080/10428190412331283288
M3 - Article
C2 - 15621781
AN - SCOPUS:19944430945
SN - 1042-8194
VL - 46
SP - 55
EP - 61
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 1
ER -