Suggested modified IWG 2018 HI-N and HI-P criteria for response evaluation
| Newly suggested evaluations: IWG 2018 . | IWG 2006 criteria . | ||
|---|---|---|---|
| Type of response . | Criteria . | Type of response . | Criteria . |
| Platelet response (pretreatment, <100 × 109/L), HI-P | • Absolute increase of 30 × 109/L for patients starting with >20 × 109/L PLTs or | Platelet response (pretreatment, <100 × 109/L), HI-P | • Absolute increase of 30 × 109/L for patients starting with >20 × 109/L PLTs or • Increase from <20 × 109/L to >20 × 109/L and by at least 100% |
| • Increase from <20 × 109/L to >20 × 109/L and by at least 100% | |||
| In addition, | |||
| • Evolution of bleeding symptoms is to be taken into account | |||
| • Increments of platelets also for patients with a pretreatment PLT count of >100 × 109/L are to be reported | |||
| Dose-adjustment policy for PLT counts on treatment | • If the drug under investigation is being stopped or its dose is being reduced in a responding patient for protocol-defined reasons leading to a loss of response, this should not be counted as such, if reintroduction at the same or lower dose of the drug induces a new response | None | |
| • When the investigational drug is stopped or reduced in dose, weekly blood counts are required to monitor the PLT levels | |||
| • 2 subsequent PLT counts >450 × 109/L are a sufficient reason for treatment discontinuation in the case of treatment with TPO agonists | |||
| Neutrophil response (pretreatment, all patients), HI-N | At least 100% increase and an absolute increase >0.5 × 109/L (pretreatment, <1.0 × 109/L) | Neutrophil response (pretreatment, <1.0 × 109/L), HI-N | At least 100% increase and an absolute increase >0.5 × 109/L |
| Increments of neutrophils also for patients with a pretreatment ANC of >1.0 × 109/L are to be reported | |||
| Newly suggested evaluations: IWG 2018 . | IWG 2006 criteria . | ||
|---|---|---|---|
| Type of response . | Criteria . | Type of response . | Criteria . |
| Platelet response (pretreatment, <100 × 109/L), HI-P | • Absolute increase of 30 × 109/L for patients starting with >20 × 109/L PLTs or | Platelet response (pretreatment, <100 × 109/L), HI-P | • Absolute increase of 30 × 109/L for patients starting with >20 × 109/L PLTs or • Increase from <20 × 109/L to >20 × 109/L and by at least 100% |
| • Increase from <20 × 109/L to >20 × 109/L and by at least 100% | |||
| In addition, | |||
| • Evolution of bleeding symptoms is to be taken into account | |||
| • Increments of platelets also for patients with a pretreatment PLT count of >100 × 109/L are to be reported | |||
| Dose-adjustment policy for PLT counts on treatment | • If the drug under investigation is being stopped or its dose is being reduced in a responding patient for protocol-defined reasons leading to a loss of response, this should not be counted as such, if reintroduction at the same or lower dose of the drug induces a new response | None | |
| • When the investigational drug is stopped or reduced in dose, weekly blood counts are required to monitor the PLT levels | |||
| • 2 subsequent PLT counts >450 × 109/L are a sufficient reason for treatment discontinuation in the case of treatment with TPO agonists | |||
| Neutrophil response (pretreatment, all patients), HI-N | At least 100% increase and an absolute increase >0.5 × 109/L (pretreatment, <1.0 × 109/L) | Neutrophil response (pretreatment, <1.0 × 109/L), HI-N | At least 100% increase and an absolute increase >0.5 × 109/L |
| Increments of neutrophils also for patients with a pretreatment ANC of >1.0 × 109/L are to be reported | |||
ANC, absolute neutrophil count; PLT, platelet; TPO, thrombopoietin.