Table 2 VOD/SOS risk factors.

From: Real-world use of defibrotide for veno-occlusive disease/sinusoidal obstruction syndrome: the DEFIFrance Registry Study

Characteristic

Primary study population: Severe/very severe VOD/SOS post-HCT (N = 251)

Mild/moderate VOD/SOS post-HCT (N = 81)

Patient-related risk factors, n/N (%)

  Advanced disease (>CR 2 or relapsed/refractory disease)

137/251 (55)

38/81 (47)

  Karnofsky or Lansky score <90%

53/240 (22)

13/77 (17)

  Second HCT

29/239 (12)

5/61 (8)

Transplant-related risk factors, n/N (%)

  Myeloablative conditioning

135/250 (54)

61/81 (75)

Hepatic risk factors,a n/N (%)

  Prior treatment with hepatotoxic drugsb

150/251 (60)

53/81 (65)

  Iron overload (ferritin >1000 ng/mL)

133/231 (58)

30/62 (48)

  Transaminases >2.5 ULN

43/250 (17)

9/81 (11)

  Bilirubinaemia >1.5 ULN

32/250 (13)

11/81 (14)

  Abdominal irradiation or hepatitis

29/251 (12)

11/81 (14)

  Prior treatment with GO or IO

23/251 (9)

9/81 (11)

  1. CR indicates complete response, GO gemtuzumab ozogamicin, HCT haematopoietic cell transplantation, IO inotuzumab ozogamicin, ULN upper limit of normal, VOD/SOS veno-occlusive disease/sinusoidal obstruction syndrome.
  2. aRisk factors occurring in >5% of patients with severe/very severe VOD/SOS post-HCT (primary study population).
  3. bPer the investigators’ discretion; hepatotoxic drugs were not defined in the protocol.
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