HI-E Response Evaluation

Proposed IWG 2018 criteria for response evaluation, HI-E¹⁶⁸

Item	Proposed IWG 2018 criteria
Baseline criteria
Transfusion burden categories	NTD: No transfusions in 16 weeks** LTB: 3-7 RBCU in 16 weeks in 2-3 transfusion episodes, max 3 in 8 wk HTB: ≥ 8 RBCU in 16 weeks, ≥ 4 U in 4 weeks
Pre-treatment RBC transfusion policy§	Individualized for the patient, maintain individualized policy during screening
Response evaluation criteria, HI-E*
NTD	≥ 2 consecutive Hb measurements ≥ 1.5g/dL for ≥ 8 weeks in a 16-24 week period compared with mean of lowest 2 Hb measurements in the 16-week baseline period
LTB	TI: No transfusions for ≥ 8 weeks in a 16-24 week period†,‡
HTB	Major response: TI, as above
	Minor response: Reduction by ≥ 50% over 16 weeks†,‡
Dose adjustment for high Hb	Hb decreases following dose reductions or interruptions should not be considered loss of response

^*For lower risk MDS where anemia is the prominent cytopenia. For severe thrombocytopenia, a shorter screening period may suffice; ^**Duration of >16 weeks is clinically meaningful; ^†Using the same transfusion policy; ^‡Compared with 16 weeks prior to start of therapy; ^§ Only transfusions for Hb <9g/dL are taken into account; ^¶ Baseline <100 (x10⁹/L), increments for patients with baseline >100 (x10⁹/L) should also be reported; evolution of bleeding symptoms should be reported; ^#2 subsequent platelet counts >450 on TPO and TPO should be stopped; declines in platelet count following dose reductions or interruptions should not be considered loss of response; ^†† Baseline >1.0 (x10⁹/L), increases are also to be reported.
HI-E, hematologic improvement erythroid; HI-N, hematologic improvement neutrophil; HI-P, hematologic improvement platelet; HTB, high transfusion burden; IWG, International Working Group; LTB, low transfusion burden; MDS, myelodysplastic syndrome; NTD, not transfusion dependent; RBC, red blood cell; U, units.
Modified from 168.