We analyzed the efficacy of all-trans retinoic acid (ATRA) as an early treatment for four acute promyelocytic leukemia (APL) patients in remission who were PML/RARalpha-positive by reverse transcription-polymerase chain reaction or fluorescence in situ hybridization. ATRA 45 mg/m2 was administered orally. All became negative for PML/RARalpha transcripts after 3 to 6 months of ATRA treatment. However, the PML/RARalpha transcripts subsequently reverted to positive in three cases. Although retreatment with ATRA failed to prevent hematological relapse in two patients, one case remains in hematological remission. No serious side effects were encountered during ATRA treatment. These findings suggest that early treatment of ATRA for PML/RARalpha-positive APL patients in remission may have a therapeutic benefit and prolong the duration of hematological remission without chemotherapy.

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