The karyotype of the leukemic cells is the strongest prognostic factor for response to induction therapy and for survival.16,17 Younger adult patients are commonly categorized into 3 risk groups, favorable, intermediate, or adverse.49-52 The most appropriate risk group assignment for a number of the rarer cytogenetic abnormalities, for example, del(7q), isolated trisomy 8, del(9q), t(v;11)(v;q23) other than t(9;11), and del(20q), remains uncertain due to limitations of sample size and differences in treatment schedule among studies. The impact of secondary genetic lesions in cases with balanced translocations or inversions requires further investigation. With the possible exception of trisomy 22 in AML with inv(16) or t(16;16) that has been associated with an improved relapse-free survival (RFS),53,54 no such impact has been shown for other secondary cytogenetic changes.
Ley 137 De 1994 Pdf Free
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Most response criteria and survival measures as described in the previous recommendations have been widely used by clinicians and cooperative groups (for definitions see Tables 5 and 6).2 Response criteria should meet the specific objective of a study, for example, in phase 2 and 3 clinical trials CR or CR with incomplete blood recovery (CRi) should be the appropriate end point, whereas in phase 1 clinical trials, the criteria of partial remission (PR) and morphologic leukemia-free state may also be useful. Other response criteria are cytogenetic CR (CRc)112-115 and molecular CR (CRm; Table 5).
This category may be useful in the clinical development of novel agents within phase 1 clinical trials, in which a transient morphologic leukemia-free state may be achieved at the time of early response assessment.
The value of allogeneic HSCT needs to be reassessed based on the identification of AML-related genetic changes that profoundly impact on prognosis, on the availability of different transplant sources (bone marrow, blood) and donor types (matched related, unrelated and haploidentical donors, umbilical cord stem cell grafts), and in light of the use of reduced-intensity conditioning (RIC) regimens.65,159 Finally, it is important to consider TRM that may vary between less than 15% and up to 50%. It is essential to assess whether the benefit of the reduced relapse rate outweighs TRM or will be offset by a high TRM. Comorbidity scores, such as the HCTCI,48,160 provide useful guidance in these decisions. Furthermore, a composite risk score, previously established for CML,161 that includes patient age, disease stage, time interval from diagnosis to transplant, donor type, and donor-recipient sex combination, has been shown to be highly predictive of TRM, leukemia-free survival, and OS also in patients with AML.162 Further risk factors include cytomegalovirus (CMV) serum status of recipient and donor,163 and non-HLA genetics, that is, SNPs or microsatellites of cytokines, cytokine receptor genes, or genes associated with innate immunity.164
Allogeneic HSCT is the preferred consolidation therapy once a new remission has been attained.234 This can be a transplant from an HLA identical sibling donor, or a matched unrelated donor. If such a donor is not available, an alternative donor can be considered, that is, an umbilical cord blood unit, or a haploidentical donor. In this situation, the risk of the disease has to be balanced with the risk of the transplant.234 The long-term value of allogeneic HSCT after RIC regimens remains to be evaluated but current experience suggests a greater relapse incidence compared with transplants after high-dose preparative regimens. If an allogeneic HSCT is not possible (eg, due to lack of a suitable donor), an autologous HSCT is often regarded as the second best option.149,240 However, often it is not possible to collect an adequate leukemia-free autograft at this phase of the disease. Retrospective studies show that patients who achieve second CR and proceed to autologous HSCT have a probability of long-term survival in the range of 20% to 50%.149 The outcome obviously applies to a highly selected minority of patients. Patients who have already undergone an allogeneic HSCT before relapse generally have immunoprophylaxis discontinued, and they may receive donor lymphocyte infusions.241-243 These interventions are not an option in patients who already have active graft-versus-host disease (GVHD). Finally, transplant recipients with a late relapse (> 1 year after allogeneic HSCT) may be offered a second transplant.244
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