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Prepublished online as a Blood First Edition Paper on August 15, 2002; DOI 10.1182/blood-2002-02-0632. This Article Full Text Full Text (PDF) All Versions of this Article: 2002-02-0632v1 100/13/4298    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Tallman, M. S. Articles by Wiernik, P. H. Search for Related Content PubMed PubMed Citation Articles by Tallman, M. S. Articles by Wiernik, P. H. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 15 December 2002, Vol. 100, No. 13, pp. 4298-4302 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS All-trans retinoic acid in acute promyelocytic leukemia: long-term outcome and prognostic factor analysis from the North American Intergroup protocol Martin S. Tallman, Janet W. Andersen, Charles A. Schiffer, Frederick R. Appelbaum, James H. Feusner, William G. Woods, Angela Ogden, Howard Weinstein, Lois Shepherd, Cheryl Willman, Clara D. Bloomfield, Jacob M. Rowe, and Peter H. Wiernik From Northwestern University, Feinburg School of Medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL (Eastern Cooperative Oncology Group [ECOG], Brookline, MA); Harvard School of Public Health, Boston, MA (ECOG); Karmanos Cancer Center, Wayne State University, Detroit, MI (Cancer and Leukemia Group B [CALGB], Chicago, IL); Fred Hutchinson Cancer Research Center, University of Washington, Seattle (Southwest Oncology Group [SWOG], San Antonio, TX); Children's Hospital of Northern California-Oakland; Emory University/ Children's Healthcare of Atlanta, GA; Texas Children's Cancer Center, Houston (Pediatric Oncology Group [POG], Chicago, IL); Massachusetts General Hospital, Harvard Medical School, Boston (POG); National Cancer Institute of Canada Clinical Trials Group, Kingston, ON; University of New Mexico, Albuquerque (SWOG); The Ohio State University, Columbus (CALGB); Rambam Medical Center, Technion, Haifa, Israel (ECOG); and Our Lady of Mercy Cancer Center, New York Medical College, Bronx (ECOG). We previously reported a benefit for all-trans retinoic acid (ATRA) in both induction and maintenance therapy in patients with acute promyelocytic leukemia (APL). To determine the durability of this benefit and identify important prognostic factors, long-term follow-up of the North American Intergroup APL trial is reported. A total of 350 patients with newly diagnosed APL were randomized to either daunorubicin and cytarabine (DA) or ATRA for induction and then either ATRA maintenance or observation following consolidation chemotherapy. The complete remission (CR) rates were not significantly different between the ATRA and DA groups (70% and 73%, respectively). However, the 5-year disease-free survival (DFS) and overall survival (OS) were longer with ATRA than with DA for induction (69% vs 29% and 69% vs 45%, respectively). Based on both induction and maintenance randomizations, the 5-year DFS was 16% for patients randomized to DA and observation, 47% for DA and ATRA, 55% for ATRA and observation, and 74% for ATRA and ATRA. There was no advantage of either induction regimen among any subgroups when CR alone was considered. However, female sex, classical M3 morphology (vs the microgranular variant [M3v]), and treatment-white blood cell count (WBC) interaction (ATRA/WBC below 2 × 109/L [2000/µL] best, DA/WBC above 2 × 109/L worst) were each significantly associated with improved DFS (P < .05). Treatment with ATRA, WBC below 2 × 109/L, and absence of bleeding disorder were each significantly associated with improved OS. Age more than 15 years, female sex, and treatment-morphology interaction (DA/M3v worst, ATRA best regardless of morphology) were each significantly associated with improved DFS based on maintenance randomization. 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	Copyright © 2002 by American Society of Hematology         Online ISSN: 1528-0020