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Blood, 1 May 2005, Vol. 105, No. 9, pp. 3420-3427.
Prepublished online as a Blood First Edition Paper on November 30, 2004; DOI 10.1182/blood-2004-08-2977.


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Submitted August 13, 2004
Accepted November 15, 2004

Sequential multiagent chemotherapy is not superior to high-dose cytarabine alone as postremission intensification therapy for acute myeloid leukemia in adults under 60 years of age: cancer and leukemia group B study 9222

Joseph O Moore, Stephen L George, Richard K Dodge, Philip C Amrein, Bayard L Powell, Jonathan E Kolitz, Maria R Baer, Frederick R Davey, Clara D Bloomfield, Richard A Larson*, and Charles A Schiffer

Duke University Medical Center, Durham, NC, USA
Duke University Medical Center, Durham, NC, USA; CALGB Statistical Center, Durham, NC, USA
Massachusetts General Hospital, Boston, MA, USA
Wake Forest University School of Medicine, Winston-Salem, NC, USA
North Shore University Hosptial, Manhasset, NY, USA
Roswell Park Cancer Institute, Buffalo, NY, USA
State University of New York Upstate Medical Center, Syracuse, NY, USA
The Ohio State University, Columbus, OH, USA
The University of Chicago, Chicago, IL, USA
Wayne State University, Detroit, MI, USA

* Corresponding author; email: rlarson{at}medicine.bsd.uchicago.edu.

CALGB study 9222 tested the hypothesis that treatment intensification of acute myeloid leukemia (AML) in first remission with multiple chemotherapy agents is superior to high-dose cytarabine (HiDAC) alone. We enrolled 474 patients < 60 years old with untreated de novo AML. Daunorubicin and cytarabine resulted in complete remission (CR) in 342 patients (72%), and 309 of these patients were randomized to receive one of 2 different intensification regimens. The first regimen consisted of 3 courses of HiDAC. The second regimen consisted of one course of HiDAC, a second course with etoposide and cyclophosphamide, and a third course with diaziquone and mitoxantrone. After a median follow-up time of 8.3 years, the median survival for all randomized patients was 2.8 years (95% CI, 1.9 -6.8 years). There was no difference in DFS between the two regimens (p=0.66). The median disease-free survival (DFS) was 1.1 years (95% CI, 0.9 -1.7 years) for patients receiving HiDAC and 1.0 year (95% CI, 0.9 -1.3 years) for those receiving multiagent chemotherapy. Cytogenetics was the only pretreatment characteristic prognostic for DFS, but there was no evidence of a differential treatment effect within cytogenetic risk groups. Toxicity was greater with multiagent chemotherapy. These two postremission regimens produce similar outcomes.


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