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.