Phase III trials in AML

There have been four large, prospective, randomized trials comparing the outcome of newly diagnosed patients with AML treated with post-remission intensive consolidation chemotherapy versus autologous versus allogeneic transplant and a fifth comparing auto to allo-BMT (Table 35.3). In all cases, allogeneic transplant was not based upon randomization, but on availability of a human leukocyte antigen (HLA)-matched sibling donor. Randomization of remaining patients to either chemotherapy or autologous transplantation was performed. With the exception of the US inter-group study, the other four studies used unpurged marrows as a stem cell source and none used growth factor support following marrow reinfusion. All studies present their results by intention-to-treat analysis.

The AML-8A EORTC-GIMEMA (European Organization for the Research and Treatment of Cancer-Gruppo Italiano Mallatie Ematologiche Maligne dell'Adulto) trial included 941 eligible and evaluable children and younger adults with newly diagnosed AML.29 Median age was 33 years (range 11-59). All patients received infusional ara-C at 200 mg/m2 for 7 days plus daunorubicin 45 mg/m2 by bolus on days 1-3. Those in remission after 1-2 cycles received a single course of intensive consolidation, consisting of intermediate dose cytarabine (500-1000 mg/m2 q12h on days 1-4) with amsacrine. Seventeen

Table 35.3 AML: Phase III trials of autologous transplant versus intensive chemotherapy or allogeneic transplant




TRM/deaths in CR (%)

Number tx/intended

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