In:
Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 14, No. 17 ( 2008-09-01), p. 5585-5593
Abstract:
Purpose: Gemtuzumab ozogamicin (GO) has been associated with an increased risk of liver sinusoidal obstruction syndrome (SOS) when applied within 3 months of allogeneic hematopoietic cell transplantation (HCT). We hypothesized that GO might be safe and effective as part of a reduced-intensity conditioning regimen as salvage therapy of CD33+ acute myeloid leukemia. Experimental Design: Thirty-one patients with acute myeloid leukemia which relapsed following conventional therapy (n = 15), autologous (n = 3), or allogeneic (n = 13) HCT were included in a prospective phase I/II trial. The preparative regimen contained 6 and 3 mg/m2 of GO on days −21 and −14 before transplantation, leading to a reduction of marrow blasts in 18 patients (58%). Eight patients received further cytoreductive chemotherapy before conditioning therapy was initiated. Fludarabine-based reduced-intensity (n = 11) or nonmyelablative (n = 16) conditioning and peripheral blood stem cell infusion from related (n = 6) or unrelated (n = 21) donors could be done in 27 patients during cytopenia. Results: Primary engraftment occurred in all evaluable patients. Only one case of reversible hepatic sinusoidal obstruction syndrome was documented. Non–relapse mortality until day 100 was 22% (n = 6). The probabilities of overall and disease-free survival at 24 months were 39% and 35%, respectively. Relapse of leukemia occurring between 2 and 24 months after transplantation (median, 8 months) was the major reason for treatment failure and death. Conclusion: These data suggest that GO can be combined with reduced-intensity conditioning even after previous autologous or allogeneic HCT.
Type of Medium:
Online Resource
ISSN:
1078-0432
,
1557-3265
DOI:
10.1158/1078-0432.CCR-08-0894
Language:
English
Publisher:
American Association for Cancer Research (AACR)
Publication Date:
2008
detail.hit.zdb_id:
1225457-5
detail.hit.zdb_id:
2036787-9