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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.
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 9222From 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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