ATRA in acute promyelocytic leukaemia trial

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This trial compared disease-free survival and overall survival in patients with previously untreated acute promyelocytic leukaemia who were randomised to ATRA+chemotherapy or chemotherapy alone.

346 patients were randomised to one of two protocols:

  • ATRA induction:
    • ATRA as induction treatment
    • patients in complete remission underwent another cycle of ATRA treatment
    • high dose daunorubicin and cytarabine
    • patients still in complete remission were randomised to maintenance with ATRA or observation

  • chemotherapy induction:
    • daunorubicin and cytarabine induction
    • patients in complete remission had another cycle of chemotherapy
    • high dose daunorubicin and cytarabine
    • patients still in complete remission were randomised to maintenance with ATRA or observation

Results:

  • ATRA and chemotherapy were equally effective as induction agents
  • disease-free survival was higher in regimens containing ATRA
  • overall survival was higher in regimens containing ATRA

Reference:

  • Tallman, MS. et al. (1997). All-trans-retinoic acid in acute promyelocytic leukaemia. New Engl. J. Med. 337, 1021-8.

Last reviewed 01/2018