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This randomised trial showed that the vitamin A derivative retinoic acid, used in induction and as maintenance, sharply improved survival in acute promyelocytic leukaemia compared with chemotherapy alone.
Phase 3 trial of 346 patients with newly diagnosed APL randomised to induction with all-trans retinoic acid or with daunorubicin plus cytarabine, and then to maintenance retinoic acid or observation.
Three-year disease-free survival was 67 percent after retinoic acid induction against 32 percent after chemotherapy, and maintenance retinoic acid further reduced relapse. The trial established retinoic acid as essential to APL therapy.
Differentiation therapy, making leukaemic cells mature rather than killing them, became the first targeted treatment in leukaemia. Every modern APL regimen starts with retinoic acid on suspicion of the diagnosis.