ATRA in acute promyelocytic leukaemia trial

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.