Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia: results of a multicenter randomized trial (European APL 91 Group)
N = 101
- Population
- Newly diagnosed APL, patients aged 65 years or less; 101 randomized at the time of the first interim analysis
- Design
- Multicenter randomized trial of daunorubicin-cytarabine chemotherapy with or without ATRA. The abstract names event-free survival as the major endpoint and reports that the trial was stopped early after the first interim analysis because EFS was significantly higher in the ATRA group. Phase not stated in the abstract.
- Primary endpoint
- EFS
- Arms
- ATRA plus chemotherapy (experimental, n = 54): ATRA combined with daunorubicin-cytarabine chemotherapy
- Chemotherapy (control, n = 47): Daunorubicin-cytarabine chemotherapy
- People
- Fenaux P, European APL 91 Group
Δ Complete remission rate+10 pointsΔ 12-month EFS+29 pointsΔ 12-month Relapse risk−21 points
Show the numbers
| Endpoint | Analysis | ATRA plus chemotherapy | Chemotherapy | Effect |
|---|---|---|---|---|
| Complete remission rate101 patients randomized at the time of the first interim analysis | interimFenaux 1993 | 91% | 81% | 49 of 54 versus 38 of 47 patients; the abstract states the CR difference was not significant. Early death 5 (9%) versus 4 (8%); resistant leukemia 0 versus 5 (10%). |
| EFS101 patients randomized at the time of the first interim analysis | interimFenaux 1993 | 79% at 12 mo | 50% at 12 mo | P=.001Kaplan-Meier estimates as published: 79% ± 7% and 50% ± 9%; the abstract gives no confidence interval. |
| Relapse risk101 patients randomized at the time of the first interim analysis | interimFenaux 1993 | 19% at 12 mo | 40% at 12 mo | P=.005Kaplan-Meier estimates of relapse as published: 19% ± 8% and 40% ± 12%; the abstract gives no confidence interval. |
| Endpoint | Analysis | ATRA plus chemotherapy | Chemotherapy | Effect |
|---|---|---|---|---|
| Complete remission rate101 patients randomized at the time of the first interim analysis | interimFenaux 1993 | 91% | 81% | 49 of 54 versus 38 of 47 patients; the abstract states the CR difference was not significant. Early death 5 (9%) versus 4 (8%); resistant leukemia 0 versus 5 (10%). |
| EFS101 patients randomized at the time of the first interim analysis | interimFenaux 1993 | 79% at 12 mo | 50% at 12 mo | P=.001Kaplan-Meier estimates as published: 79% ± 7% and 50% ± 9%; the abstract gives no confidence interval. |
| Relapse risk101 patients randomized at the time of the first interim analysis | interimFenaux 1993 | 19% at 12 mo | 40% at 12 mo | P=.005Kaplan-Meier estimates of relapse as published: 19% ± 8% and 40% ± 12%; the abstract gives no confidence interval. |
Appears in
Sources
Fenaux P, Le Deley MC, Castaigne S, Archimbaud E, Chomienne C, Link H, et al. Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia. Results of a multicenter randomized trial. European APL 91 Group. Blood. 1993;82(11):3241-9.