AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance.

Abstract

All-trans-retinoic acid (ATRA) has greatly modified the prognosis of acute promyelocytic leukemia; however, the role of maintenance in patients in molecular complete remission after consolidation treatment is still debated. From July 1993 to May 2000, 807 genetically proven newly diagnosed acute promyelocytic leukemia patients received ATRA plus idarubicin as induction, followed by 3 intensive consolidation courses. Thereafter, patients reverse-transcribed polymerase chain reaction-negative for the PML-RARA fusion gene were randomized into 4 arms: oral 6-mercaptopurine and intramuscular methotrexate (arm 1); ATRA alone (arm 2); 3 months of arm1 alternating to 15 days of arm 2 (arm 3); and no further therapy (arm 4). Starting from February 1997, randomization was limited to ATRA-containing arms only (arms 2 and 3). Complete remission was achieved in 761 of 807 (94.3%) patients, and 681 completed the consolidation program. Of these, 664 (97.5%) were evaluated for the PML-RARA fusion gene, and 586 of 646 (90.7%) who tested reverse-transcribed polymerase chain reaction-negative were randomized to maintenance. The event-free survival estimate at 12 years was 68.9% (95% confidence interval, 66.4%-71.4%), and no differences in disease-free survival at 12 years were observed among the maintenance arms.

• Authors: Giuseppe Avvisati, Francesco Lo-Coco, Francesca Paola Paoloni, Maria Concetta Petti, Daniela Diverio, Marco Vignetti, Roberto Latagliata, Giorgina Specchia, Michele Baccarani, Eros Di Bona, Giuseppe Fioritoni, Filippo Marmont, Alessandro Rambaldi, Francesco Di Raimondo, Maria Grazia Kropp, Giovanni Pizzolo, Enrico M Pogliani, Giuseppe Rossi, Nicola Cantore, Francesco Nobile, Attilio Gabbas, Felicetto Ferrara, Paola Fazi, Sergio Amadori, Franco Mandelli, GIMEMA, AIEOP, and EORTC Cooperative Groups
• Journal: Blood (Blood) Vol. 117 Issue 18 Pg. 4716-25 (May 05 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21385856 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Oncogene Proteins, Fusion
• promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein
• Tretinoin
• Idarubicin

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols
• Child
• Child, Preschool
• Clinical Protocols
• Disease-Free Survival
• Female
• Humans
• Idarubicin (administration & dosage)
• Infant
• Leukemia, Promyelocytic, Acute (diagnosis, drug therapy, genetics)
• Male
• Middle Aged
• Oncogene Proteins, Fusion (genetics)
• Remission Induction
• Tretinoin (administration & dosage)
• Young Adult