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A prospective randomized toxicity study to compare reduced‐intensity and myeloablative conditioning in patients with myeloid leukaemia undergoing allogeneic haematopoietic stem cell transplantation
Author(s) -
Ringdén O.,
Erkers T.,
Aschan J.,
GarmingLegert K.,
Blanc K.,
Hägglund H.,
Omazic B.,
Svenberg P.,
Dahllöf G.,
Mattsson J.,
Ljungman P.,
Remberger M.
Publication year - 2013
Publication title -
journal of internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.625
H-Index - 160
eISSN - 1365-2796
pISSN - 0954-6820
DOI - 10.1111/joim.12056
Subject(s) - medicine , mucositis , gastroenterology , transplantation , toxicity , hematology , hematopoietic stem cell transplantation , myeloid , hemorrhagic cystitis , surgery , immunology
Background To our knowledge, no randomized toxicity studies have been conducted to compare myeloablative conditioning ( MAC ) and reduced‐intensity conditioning ( RIC ) in allogeneic haematopoietic stem cell transplantation ( HSCT ). Methods Adult patients ≤60 years of age with myeloid leukaemia were randomly assigned (1 : 1) to treatment with RIC ( n = 18) or MAC ( n = 19) in this Phase II single‐centre toxicity study. Results There was a maximum median mucositis grade of 1 in the RIC group compared with 4 in the MAC group ( P < 0.001). Haemorrhagic cystitis occurred in eight of the patients in the MAC group and none in the RIC group ( P < 0.01). Results of renal and hepatic tests did not differ significantly between the two groups. RIC ‐treated patients had faster platelet engraftment ( P < 0.01) and required fewer erythrocyte and platelet transfusions ( P < 0.001) and less total parenteral nutrition ( TPN ) than those treated with MAC ( P < 0.01). Cytomegalovirus ( CMV ) infection was more common in the MAC group (14/19) than in the RIC group (6/18) ( P = 0.02). Donor chimerism was similar in the two groups with regard to CD 19 and CD 33, but was delayed for CD 3 in the RIC group. Five‐year transplant‐related mortality ( TRM ) was approximately 11% in both groups, and rates of relapse and survival were not significantly different. Patients in the MAC group with intermediate cytogenetic acute myeloid leukaemia had a 3‐year survival of 73%, compared with 90% among those in the RIC group. Conclusion Reduced‐intensity conditioning had several advantages compared with MAC , including less mucositis, less haemorrhagic cystitis, faster platelet engraftment, the need for fewer transfusions and less TPN , and fewer CMV infections. Both regimens were tolerated and TRM was low.