Table 3.

Definition of response for each core clinicohematologic criterion


Criterion

Complete response

Partial response

Progression
Hemoglobin (Hb) level   Hb ≥ 120 g/L for patients with Hb < 100 g/L; or achievement of transfusion independence, with stable Hb > 110 g/L, for RBC transfusion-dependent patients   Increase of Hb ≥ 20 g/L (but Hb < 120 g/L) for non-RBC transfusion-dependent patients; or reduction ≥ 50% of transfusion requirement for RBC transfusion-dependent patients   Decrease of Hb ≥ 20 g/L or transfusion requirement for non-RBC transfusion-dependent patients; or increase ≥ 50% of transfusion requirement for RBC transfusion-dependent patients  
Splenomegaly*  Spleen not palpable   Decrease of spleen size ≥ 50% in patients with spleen size ≤ 10 cm from the left costal margin; or decrease of spleen size ≥ 30% in patients with spleen size > 10 cm from the left costal margin   Increase of spleen size ≥ 50% in patients with spleen size ≤ 10 cm from the left costal margin; or increase of spleen size ≥ 30% in patients with spleen size > 10 cm from the left costal margin  
Constitutional symptoms  Absence of constitutional symptoms   n/a   Appearance of constitutional symptoms  
Platelet (PTL) count   PTL count 150 × 109/L to 400 × 109/L   Decrease of PTL count ≥ 50% without normalization in patients with PTL count > 800 × 109/L; or increase of PTL count ≥ 50 × 109/L without normalization for patients with PTL count < 100 × 109/L   n/a  
White blood cell (WBC) count
 
WBC count 4 × 109/L to 10 × 109/L
 
Decrease of WBC count ≥ 50% without normalization in patients with WBC count > 20 × 109/L; or increase of WBC count ≥ 1 × 109/L without normalization in patients with WBC count < 4 × 109/L
 
n/a
 

Criterion

Complete response

Partial response

Progression
Hemoglobin (Hb) level   Hb ≥ 120 g/L for patients with Hb < 100 g/L; or achievement of transfusion independence, with stable Hb > 110 g/L, for RBC transfusion-dependent patients   Increase of Hb ≥ 20 g/L (but Hb < 120 g/L) for non-RBC transfusion-dependent patients; or reduction ≥ 50% of transfusion requirement for RBC transfusion-dependent patients   Decrease of Hb ≥ 20 g/L or transfusion requirement for non-RBC transfusion-dependent patients; or increase ≥ 50% of transfusion requirement for RBC transfusion-dependent patients  
Splenomegaly*  Spleen not palpable   Decrease of spleen size ≥ 50% in patients with spleen size ≤ 10 cm from the left costal margin; or decrease of spleen size ≥ 30% in patients with spleen size > 10 cm from the left costal margin   Increase of spleen size ≥ 50% in patients with spleen size ≤ 10 cm from the left costal margin; or increase of spleen size ≥ 30% in patients with spleen size > 10 cm from the left costal margin  
Constitutional symptoms  Absence of constitutional symptoms   n/a   Appearance of constitutional symptoms  
Platelet (PTL) count   PTL count 150 × 109/L to 400 × 109/L   Decrease of PTL count ≥ 50% without normalization in patients with PTL count > 800 × 109/L; or increase of PTL count ≥ 50 × 109/L without normalization for patients with PTL count < 100 × 109/L   n/a  
White blood cell (WBC) count
 
WBC count 4 × 109/L to 10 × 109/L
 
Decrease of WBC count ≥ 50% without normalization in patients with WBC count > 20 × 109/L; or increase of WBC count ≥ 1 × 109/L without normalization in patients with WBC count < 4 × 109/L
 
n/a
 

Values must be stable for at least 4 weeks.

n/a indicates not applicable.

*

Measured in cm below the left costal margin.

Unexplained recurrent fever 38.0°C or above, drenching night sweats, or 10% or more body weight loss.

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