HARMONY
Acute promyelocytic leukemia: long-term outcomes from the HARMONY project
Phase observationalN = 1,438
- Population
- Newly diagnosed APL, diagnosed between 1999 and 2022, median age 50.5 years (range 16 to 94)
- Design
- Observational analysis of the HARMONY Platform pooling patient data from the APL0406 and AML17 trials and four European registries (1438 newly diagnosed patients). Of 1309 patients starting therapy, 562 received ATRA-arsenic trioxide and 747 idarubicin-based chemotherapy (AIDA-like); outcomes were compared between these groups. Not randomized.
- Arms
- ATRA-arsenic trioxide (experimental, n = 562): ATRA plus arsenic trioxide
- AIDA-like chemotherapy (control, n = 747): Idarubicin-based chemotherapy with ATRA (AIDA-like)
- People
- Voso MT
Δ 84-month OS+10 pointsΔ 84-month EFS+18 pointsΔ 84-month Relapse risk−10 points
Show the numbers
| Endpoint | Analysis | ATRA-arsenic trioxide | AIDA-like chemotherapy | Effect |
|---|---|---|---|---|
| OSPatients given ATRA-arsenic trioxide (562) or AIDA-like chemotherapy (747); the abstract does not label the analysis population | finalmedian follow-up 5.5 yearsVoso 2025 | 91% at 7 y | 81% at 7 y | P<0.001 for all outcomesObservational comparison, not randomized. The abstract gives HR 2.14 (95% CI 1.51 to 3.05) next to the AIDA-like value but does not state the reference group, so no hazard-ratio direction is recorded here. |
| EFSPatients given ATRA-arsenic trioxide (562) or AIDA-like chemotherapy (747); the abstract does not label the analysis population | finalmedian follow-up 5.5 yearsVoso 2025 | 89% at 7 y | 71% at 7 y | P<0.001 for all outcomesObservational comparison, not randomized. Published HR 2.72 (95% CI 2.01 to 3.69); reference group not stated in the abstract. |
| Relapse riskPatients given ATRA-arsenic trioxide (562) or AIDA-like chemotherapy (747); the abstract does not label the analysis population | finalmedian follow-up 5.5 yearsVoso 2025 | 3% at 7 y | 13% at 7 y | P<0.001 for all outcomesObservational comparison, not randomized; the abstract does not say whether relapse is a cumulative incidence. Published HR 4.19 (95% CI 2.38 to 7.39); reference group not stated in the abstract. |
| Endpoint | Analysis | ATRA-arsenic trioxide | AIDA-like chemotherapy | Effect |
|---|---|---|---|---|
| OSPatients given ATRA-arsenic trioxide (562) or AIDA-like chemotherapy (747); the abstract does not label the analysis population | finalmedian follow-up 5.5 yearsVoso 2025 | 91% at 7 y | 81% at 7 y | P<0.001 for all outcomesObservational comparison, not randomized. The abstract gives HR 2.14 (95% CI 1.51 to 3.05) next to the AIDA-like value but does not state the reference group, so no hazard-ratio direction is recorded here. |
| EFSPatients given ATRA-arsenic trioxide (562) or AIDA-like chemotherapy (747); the abstract does not label the analysis population | finalmedian follow-up 5.5 yearsVoso 2025 | 89% at 7 y | 71% at 7 y | P<0.001 for all outcomesObservational comparison, not randomized. Published HR 2.72 (95% CI 2.01 to 3.69); reference group not stated in the abstract. |
| Relapse riskPatients given ATRA-arsenic trioxide (562) or AIDA-like chemotherapy (747); the abstract does not label the analysis population | finalmedian follow-up 5.5 yearsVoso 2025 | 3% at 7 y | 13% at 7 y | P<0.001 for all outcomesObservational comparison, not randomized; the abstract does not say whether relapse is a cumulative incidence. Published HR 4.19 (95% CI 2.38 to 7.39); reference group not stated in the abstract. |