Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia. Results of a multicenter randomized trial. European APL 91 Group
作者： P Fenaux , MC Le Deley , S Castaigne , E Archimbaud , C Chomienne
DOI: 10.1182/BLOOD.V82.11.3241.3241
关键词:
摘要: We designed a multicenter randomized trial comparing chemotherapy with daunorubicin-Ara C (chemotherapy group) and all transretinoic acid (ATRA) combined to the same (ATRA in newly diagnosed APL patients aged 65 years or less. The major endpoint of study was event-free survival (EFS) (“events” being defined as failure achieve complete remission [CR], occurrence relapse, death CR). Early termination decided after first interim analysis, EFS significantly higher ATRA group. At time, 101 had been (54 group 47 group). In group, 49 (91%) achieved CR, 5 (9%) early death, 0 resistant leukemia, compared 38 (81%), 4 (8%), (10%) patients, respectively, difference CR rate between two groups not significant. duration coagulopathy reduced six relapsed 7 15.5 months. 12 1 16 months, 2 died CR. Kaplan-Meier estimated at 79% +/- 7% 50% 9% (P = .001). estimate relapse 19% 8% 40% 12% months .005). conclusion, followed by increases APL. These results strongly suggest that should be incorporated front line therapy
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