Randomized clinical study comparing aggressive chemotherapy with or without G-CSF support for high-risk myelodysplastic syndromes or secondary acute myeloid leukaemia evolving from MDS

Carlo Bernasconi, E. Paolo Alessandrino, Paolo Bernasconi, Maurizio Bonfichi, Mario Lazzarino, Angelo Canevari, Guglielmo Castelli, Ercole Brusamolino, Guido Pagnucco, Carlo Castagnola

Research output: Contribution to journalArticlepeer-review

Abstract

One hundred and five consecutive primary high-risk myelodysplastic syndromes (MDS) or secondary acute myeloid leukaemia (sAML) evolving from MDS (performance status 0-3, ECOG) entered this study. Induction chemotherapy (CT) consisted of idarubicine 12 mg/m2 i.v. on days 1 and 2, etoposide 60 mg/m2/12 h i.v. for 5 d, Ara-C 120 mR/m2/12 h i.v. for 5d (one or two courses). Patients were randomized to receive or not G-CSF (5 μg/kg/d subcutaneously 48 h after the end of CT). 52 cases underwent CT alone and 53 CT+G-CSF. The CT+G-CSF patients had a significantly shorter duration of neutropenia (8 v 16 d) with a lower incidence of infections and significantly better responses (CR+PR: 74% v 52%, P2 every 12 h for 3 d). Most CRs were clonal. At present 21 responders have relapsed (median relapse-free survival 4.5 months). Eight responders received an allo-BMT, six are alive in CR 7-57 months post-transplant. Therefore allo-BMT only increases the chance of a long survival and possible cure. In conclusion, CT+G-CSF did not prolong either CR duration or survival; the growth factor support, however, increased the number of allo-transplantable cases by inducing higher remission rates and improving clinical conditions.

Original languageEnglish
Pages (from-to)678-683
Number of pages6
JournalBritish Journal of Haematology
Volume102
Issue number3
DOIs
Publication statusPublished - 1998

Keywords

  • Chemotherapy
  • G-CSF
  • MDS
  • sAML
  • Survival

ASJC Scopus subject areas

  • Hematology

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