United States multicenter study of arsenic trioxide in relapsed acute promyelocytic leukemia
N = 40
- Population
- Patients with APL in first relapse (21) or second or later relapse (19)
- Design
- Multicenter treatment series: daily arsenic trioxide infusions to a maximum of 60 doses or until leukemic cells were eliminated from bone marrow; one consolidation course for patients in complete remission, then optional maintenance. Phase not stated in the abstract.
- Arms
- Arsenic trioxide (experimental, n = 40): Daily arsenic trioxide infusions, up to 60 doses, then one consolidation course
- People
- Soignet SL
Show the numbers
| Endpoint | Analysis | Arsenic trioxide | Control | Effect |
|---|---|---|---|---|
| Complete remission rate40 treated patients | primarySoignet 2001 | 85% | — | 34 of 40 patients; 31 (91%) of those in complete remission were negative for t(15;17) on cytogenetic testing after treatment. Two patients died during induction, neither from drug-related causes. QT prolongation on electrocardiogram was common (63%), and ten patients developed signs or symptoms suggestive of the APL syndrome. The FDA labels report 28 of 40 patients (70%) for the multicenter study PLRXAS01 under a definition that requires a confirmatory bone marrow at least 30 days later; the EMA scientific discussion gives 34 of 40 (85%) for the same study, as here. |
| OS40 treated patients | primarySoignet 2001 | 66% at 18 mo | — | Estimate as published; the abstract gives no confidence interval. |
| RFS40 treated patients | primarySoignet 2001 | 56% at 18 mo | — | Estimate as published; the abstract gives no confidence interval. Eleven patients had a transplant after arsenic trioxide (eight allogeneic, three autologous). |
| Endpoint | Analysis | Arsenic trioxide | Control | Effect |
|---|---|---|---|---|
| Complete remission rate40 treated patients | primarySoignet 2001 | 85% | — | 34 of 40 patients; 31 (91%) of those in complete remission were negative for t(15;17) on cytogenetic testing after treatment. Two patients died during induction, neither from drug-related causes. QT prolongation on electrocardiogram was common (63%), and ten patients developed signs or symptoms suggestive of the APL syndrome. The FDA labels report 28 of 40 patients (70%) for the multicenter study PLRXAS01 under a definition that requires a confirmatory bone marrow at least 30 days later; the EMA scientific discussion gives 34 of 40 (85%) for the same study, as here. |
| OS40 treated patients | primarySoignet 2001 | 66% at 18 mo | — | Estimate as published; the abstract gives no confidence interval. |
| RFS40 treated patients | primarySoignet 2001 | 56% at 18 mo | — | Estimate as published; the abstract gives no confidence interval. Eleven patients had a transplant after arsenic trioxide (eight allogeneic, three autologous). |