Maintenance therapy with decitabine in younger adults with acute myeloid leukemia in first remission: a phase 2 Cancer and Leukemia Group B Study (CALGB 10503).
In this prospective phase 2 clinical trial conducted by Cancer and Leukemia Group B (CALGB, now the Alliance), we studied decitabine as maintenance therapy for younger adults with acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive induction and consolidation. Given that decitabine is clinically active in AML and with hypomethylating activity distinct from cytotoxic chemotherapy, we hypothesized that 1 year of maintenance therapy would improve disease-free survival (DFS) for AML patients <60 years, who did not receive allogeneic stem cell transplantation in CR1. After blood count recovery from final consolidation, patients received decitabine at 20 mg/m2intravenously daily for 4-5 days, every 6 weeks for eight cycles. One hundred and thirty-four patients received decitabine and 85 (63%) had favorable risk AML. The median number of cycles received was 7 (range: 1-8) and the primary reason for discontinuation was relapse. DFS at 1 year and 3 years was 79% and 54%, respectively. These results are similar to the outcomes in the historical control comprising similar patients treated on recent CALGB trials. Thus, maintenance with decitabine provided no benefit overall. Standard use of decitabine maintenance in younger AML patients in CR1 is not warranted. This trial was registered at www.clinicaltrials.gov as NCT00416598.
Division of Hematology and the Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
W
W
Blum
The Alliance for Clinical Trials in Oncology Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
B L
BL
Sanford
Division of Hematology and the Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
R
R
Klisovic
Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, USA.
D J
DJ
DeAngelo
Department of Medicine, Washington University in St. Louis, St. Louis, MO, USA.
G
G
Uy
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, NC, USA.
B L
BL
Powell
Department of Medicine, University of Chicago, Chicago, IL, USA.
W
W
Stock
Department of Medicine and Greenebaum Cancer Center University of Maryland, Baltimore, MD, USA.
M R
MR
Baer
Hofstra North Shore-Long Island Jewish School of Medicine, Manhasset, NY, USA.
J E
JE
Kolitz
Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.
E S
ES
Wang
The Alliance for Clinical Trials in Oncology Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
E
E
Hoke
Division of Hematology and the Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
K
K
Mrózek
Division of Hematology and the Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.|The Alliance for Clinical Trials in Oncology Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
J
J
Kohlschmidt
Division of Hematology and the Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
C D
CD
Bloomfield
Health Informatics Institute, University of South Florida, Tampa, FL, USA.
S
S
Geyer
Gehr Family Leukemia Center, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
G
G
Marcucci
Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, USA.
R M
RM
Stone
Department of Medicine, University of Chicago, Chicago, IL, USA.
R A
RA
Larson
D000293:Adolescent; D000328:Adult; D001374:Azacitidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077209:Decitabine; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D015996:Survival Rate; D055815:Young Adult
D000077209:Decitabine; D001374:Azacitidine