IWG 2023 time-to-event end points for HR-MDS
| Time-to-event–based outcome . | IWG 2006 . | IWG 2023 . |
|---|---|---|
| OS | Death from any cause | Defined for all participants of a trial. Measured from the date of study registration (for nonrandomized studies) or randomization (for randomized studies) to the date of death from any cause. Patients not known to have died are censored on the last date they were last known to be alive. |
| EFS | Treatment failure or death from any cause | Defined for all participants of a trial. Measured from the date of study registration (or randomization) to the date of the first of the following events:•PD as defined in Table 2.•Failure to achieve CR (or CR equivalent), PR, CRL CRh, or HI within 6 mo of study entry.•Relapse from CR (or CR equivalent), PR, CRL CRh, or HI.•Death from any cause.Patients not known to have any of these events are censored on the last date they were known not to have any of these events. |
| PFS | Disease progression or death from any cause | Defined for all participants of a trial. Measured from the date of study entry (or randomization) to the date of the first of the following events:•PD as defined in Table 2.•Relapse from CR (or CR equivalent), PR, CRLCRh, or HI.•Death from any cause.Patients not known to have any of these events are censored on the last date they were known not to have any of these events. |
| Disease-free survival | Time to relapse | Eliminated |
| Time-to-event–based outcome . | IWG 2006 . | IWG 2023 . |
|---|---|---|
| OS | Death from any cause | Defined for all participants of a trial. Measured from the date of study registration (for nonrandomized studies) or randomization (for randomized studies) to the date of death from any cause. Patients not known to have died are censored on the last date they were last known to be alive. |
| EFS | Treatment failure or death from any cause | Defined for all participants of a trial. Measured from the date of study registration (or randomization) to the date of the first of the following events:•PD as defined in Table 2.•Failure to achieve CR (or CR equivalent), PR, CRL CRh, or HI within 6 mo of study entry.•Relapse from CR (or CR equivalent), PR, CRL CRh, or HI.•Death from any cause.Patients not known to have any of these events are censored on the last date they were known not to have any of these events. |
| PFS | Disease progression or death from any cause | Defined for all participants of a trial. Measured from the date of study entry (or randomization) to the date of the first of the following events:•PD as defined in Table 2.•Relapse from CR (or CR equivalent), PR, CRLCRh, or HI.•Death from any cause.Patients not known to have any of these events are censored on the last date they were known not to have any of these events. |
| Disease-free survival | Time to relapse | Eliminated |