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United States Multicenter Study of Arsenic Trioxide in Relapsed Acute Promyelocytic Leukemia

From the Leukemia and Developmental Chemotherapy Services, Department of Medicine, and Pediatric Department, Memorial Sloan-Kettering Cancer Center and Joan and Sanford Weill Medical College of Cornell University, New York, NY; Lombardi Cancer Center, Georgetown University Medical Center, Washington, DC; Norris Cancer Center and University of Southern California Keck School of Medicine, University of Southern California, Los Angeles; Stanford University Medical Center, Stanford, CA; Northwestern University of Medical School, Chicago, IL; M.D. Anderson Cancer Center, Houston, TX; Dana-Farber Cancer Center, Boston, MA; Cleveland Clinic Foundation, Cleveland, OH; and Fred Hutchinson Cancer Research Center and Cell Therapeutics Inc, Seattle, WA.

Address reprint requests to Steven L. Soignet, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; email: soignets{at}mskcc.org

PURPOSE: To determine the safety and efficacy of arsenic trioxide (ATO) in patients with relapsed acute promyelocytic leukemia (APL).

PATIENTS AND METHODS: Forty patients experiencing first (n = 21) or second (n = 19) relapse were treated with daily infusions of ATO to a maximum of 60 doses or until all leukemic cells in bone marrow were eliminated. Patients who achieved a complete remission (CR) were offered one consolidation course of ATO that began 3 to 4 weeks later. Patients who remained in CR were eligible to receive further cycles of ATO therapy on a maintenance study.

RESULTS: Thirty-four patients (85%) achieved a CR. Thirty-one patients (91%) with CRs had posttreatment cytogenetic tests negative for t(15;17). Eighty-six percent of the patients who were assessable by reverse transcriptase polymerase chain reaction converted from positive to negative for the promyelocytic leukemia/retinoic acid receptor-alpha transcript by the completion of their consolidation therapy. Thirty-two patients received consolidation therapy, and 18 received additional ATO as maintenance. Eleven patients underwent allogeneic (n = 8) or autologous (n = 3) transplant after ATO treatment. The 18-month overall and relapse-free survival (RFS) estimates were 66% and 56%, respectively. Twenty patients (50%) had leukocytosis (> 10,000 WBC/µL) during induction therapy. Ten patients developed signs or symptoms suggestive of the APL syndrome and were effectively treated with dexamethasone. Electrocardiographic QT prolongation was common (63%). One patient had an absolute QT interval of > 500 msec and had an asymptomatic 7-beat run of torsades de pointe. Two patients died during induction, neither from drug-related causes.

CONCLUSION: This study establishes ATO as a highly effective therapy for patients with relapsed APL.

S.L.S. is a Mortimer J. Lacher fellow.

Presented in part at the Annual Meeting of the American Society of Hematology, San Francisco, CA, December 1-5, 2000.

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