Prior treatment with gemtuzumab ozogamicin and the risk of veno-occlusive disease after allogeneic haematopoietic stem cell transplantation.
This was a retrospective multicenter study including 44 acute leukaemia patients who have received allogeneic haematopoietic SCT (allo-HSCT) after prior exposure to Gemtuzumab Ozogamicin (GO) + chemotherapy. Median interval between last administration of GO and allo-HSCT was 4.2 (range, 0.8-26.3) months. At time of allo-HSCT, 33 patients were in CR. The majority of patients (n=36) received a reduced-intensity conditioning (RIC) regimen before allo-HSCT. All but one patient received low-dose heparin for veno-occlusive disease (VOD) prophylaxis. With a median follow-up of 15 (range, 1.1-63) months, overall survival and disease-free survival after allo-HSCT were 45% (95% confidence interval (CI), 30-61%) and 38% (95% CI, 24-54%) at 2 years, respectively. The cumulative incidence of grade 3-4 hyperbilirubinemia was 13.5% (n=6), with this being 21% in patients with a short (< or =3.5 months) GO-allo-HSCT interval (n=4/19) vs 8% in all others (P=NS). Overall, the cumulative incidence of VOD was 7% (n=3), with this being 10.5% (n=2/19) in patients with a short GO-allograft interval (< or =3.5 months) vs 4% (n=1/25) for all others (P=NS), and 5.5% (n=2/36) in patients receiving an RIC regimen vs 12.5% for the others (n=1/8) (P=NS). These results suggest that GO-based chemotherapy before allo-HSCT is feasible and does not result in an excessive rate of liver toxicity, especially VOD, after allo-HSCT.
Chevallier
P
P
Service d'Hématologie Clinique, CHU Hotel-Dieu, Nantes, Cedex 01, France. patrice.chevallier@chu-nantes.fr
Prebet
T
T
Turlure
P
P
Hunault
M
M
Vigouroux
S
S
Harousseau
J-L
JL
Blaise
D
D
Ifrah
N
N
Milpied
N
N
Mohty
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000009:adverse effects* / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D005260:Female; D000079982:Gemtuzumab; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006493:Heparin / Q000627:therapeutic use; D006504:Hepatic Veno-Occlusive Disease / Q000209:etiology* / Q000517:prevention & control; D006801:Humans; D007938:Leukemia / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D019172:Transplantation Conditioning / Q000379:methods; D016896:Treatment Outcome
D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D006493:Heparin; D000079982:Gemtuzumab