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Prepublished online as a Blood First Edition Paper on August 15, 2002; DOI 10.1182/blood-2002-02-0632.
Submitted February 27, 2002
Accepted June 17, 2002
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
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Medical School, Chicago, IL, USA
Harvard School of Public Health, Boston, MA, USA; Eastern Cooperative Oncology Group, Brookline, MA, USA
Karmanos Cancer Center, Wayne State University, Detroit, MI, USA; Cancer and Leukemia Group B, Chicago, IL, USA
Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, USA
Children's Hospital of Northern California, Oakland, CA, USA
Emory University/Children's Healthcare of Atlanta, Atlanta, GA, USA
Texas Children's Cancer Center, Houston, TX, USA
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Pediatric Oncology Group, Chicago, IL, USA
National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada
University of New Mexico, Albuquerque, NM, USA; Southwest Oncology Group, San Antonio, TX, USA
The Ohio State University, Columbus, OH, USA; Cancer and Leukemia Group B, Chicago, IL, USA
Technion, Rambam Medical Center, Haifa, Israel; Eastern Cooperative Oncology Group, Brookline, MA, USA
Our Lady of Mercy Cancer Center, New York Medical College, Bronx, NY, USA; Eastern Cooperative Oncology Group, Brookline, MA, USA
* Corresponding author; email: m-tallman{at}northwestern.edu.
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. Three hundred fifty patients with newly diagnosed APL were randomized to either daunorubicin and cytarabine (DA) or ATRA for induction, then either ATRA maintenance or observation following consolidation chemotherapy. The complete remission (CR) rates were not significantly different (70% and 73% respectively). However, the 5-year disease-free survival (DFS), and overall survival (OS) were longer with ATRA for induction (29% vs. 69% and 45% vs. 69%, 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 gender, classical M3 morphology [vs. the microgranular variant (M3v)] and treatment/white blood cell count (WBC) interaction (ATRA/WBC <2,000/mL best, DA/WBC >2,000/mL worst) were each significantly associated with improved DFS (P <0.05). Treatment with ATRA, WBC <2,000/mL and absence of bleeding disorder were each significantly associated with improved OS. Age >15 years, female gender and treatment/morphology interaction (DA/M3v worst, ATRA best regardless of morphology) were each significantly associated with improved DFS based on maintenance randomization. The improvement in outcome with ATRA in APL was maintained with long-term follow-up.
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