180 (18%)

335 (33%)

Inv(16) or t(8;21)

128 (12%)

22 (2%)


932 (39%)

337 (33%)


265 (26%)

294 (29%)


47 (5%)

32 (3%)

palliative care should be strongly considered given that the 20-30% risk of TRM rate with SCH is not commensurate with the benefits offered by this type of therapy.

Before proceeding to a discussion of investigational therapy, the role of allogeneic stem cell transplant should be discussed. In patients in first CR, "standard" transplant, i.e., using cyclophosphamide and total body irradiation or oral busulfan and cells from an HLA-identical or 1-antigen mismatched sibling donor, is distinguished from "investigational" transplant. The largest trials comparing SCH with standard transplant (allogeneic stem cell transplantation or allo SCT) in first CR minimize selection biases by including patients in the transplant group if they had a donor regardless of whether they had a transplant. These indicate that, on average, patients in the no donor group and donor groups have similar survival.1314 No trials address this issue in a similar fashion, restricting attention to patients with secondary AML/MDS. However, there are studies that examine the effect of having a donor in subgroups defined by other prognostic factors. The largest study to examine the effect of cytogenetics15 found a trend for patients with inv(16) or t(8;21) to live longer if assigned to chemotherapy rather than allo SCT, while patients with prognostically intermediate karyotypes [any but inv(16), t(8;21), -5, -7, 5q-, 7q-, or more than three abnormalities] lived longer with allo SCT, but only if patients were younger than 35. Most importantly, outcome was similarly poor in the adverse karyotype group (-5, -7, 5q-, 7q-, or more than three abnormalities) regardless of whether patients were assigned to allo SCT or chemotherapy. Similarly, autologous SCT does not affect prognosis in these patients.16 Both the Medical Research Council (MRC) AML 10 and AML 12 trials1517 and a previous MRC study18 make clear that the principal determinant of outcome remains the prognostic group regardless of patients' donor status. Further suggestion that similar prognostic factors are operative for allo SCT and chemotherapy are data indicating that (1) in patients transplanted in second CR, RFS is influenced by length of the first chemotherapy-maintained CR, as is the case when patients receive chemotherapy to maintain a second CR,19 and (2) allo SCT does not appear to alter the poor prognosis of patients with FLT3 mutations.20 Furthermore, although approximately 90% of allo SCT survivors are in good health years after the procedure,21 they are clearly at increased risk for subsequent development of solid cancers2223; a similar risk is not apparent in long-term survivors of chemotherapy.9 Thus, unless secondary AML is thought to represent a unique prognostic group, there is no compelling evidence to recommend that patients with secondary AML in first CR receive conventional SCT. If, however, a decision is made to proceed to allo SCT once first CR is observed, administration of consolidation therapy prior to transplantation appears to be of no value.24

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