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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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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

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

From the Duke University Medical Center, Durham, NC; CALGB (Cancer and Leukemia Group B) Statistical Center, Durham, NC; Massachusetts General Hospital, Boston, MA; Wake Forest University School of Medicine, Winston-Salem, NC; North Shore University Hospital, Manhasset, NY; Roswell Park Cancer Institute, Buffalo, NY; State University of New York Upstate Medical Center, Syracuse, NY; Ohio State University, Columbus, OH; University of Chicago, Chicago, IL; Wayne State University, Detroit, MI; and the Cancer and Leukemia Group B, Chicago, IL.

The Cancer and Leukemia Group B (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 younger than 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 disease-free survival (DFS) between the 2 regimens (P = .66). The median 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 2 postremission regimens produced similar outcomes.


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