Neuraminidase-Treated Allogeneic Blasts for Maintenance in Acute Myelogenous Leukemia: Results of a Prospective Randomized Trial

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Abstract
Between July 1, 1981, and July 1, 1985, 167 patients with acute myelogeneous leukemia (AML) were treated with one or, if necessary, two courses of a modified TAD regimen (TAD9) for induction. 96 patients (58%) achieved a complete remission (CR); 62 achieved CR after one and 34 patients after two courses of TAD9. 29 patients (17%) were considered early deaths, and 42 patients (25%) nonresponders. For CR maintenance 64 patients were eligible according to protocol criteria; 33 patients were randomized to chemotherapy, only, (CT) by monthly courses of cytosine arabinoside (ARA-C) alternatingly combined with daunorubicin or thioguanine or cyclophosphamide, while 31 patients were randomized to receive immunotherapy in addition to chemotherapy (CIT) by intradermal injections of 1010 neuraminidase-treated viable allogeneic blasts per immunization interspersed between the CT courses. Maintenance therapy was given for up to 3 years. The median survival in CT patients is 23 months, while in CIT patients the median has not been reached after 54 months; corresponding median relapse-free survival is 15 months for the CT patients as opposed to 40 months for the CIT group. The differences are not significant. Comparing CT with CIT, the survival data show a persistent trend in favor of CIT; under the conditions of the study, however, a substantial benefit of immunotherapy may be restricted to a certain subset of patients with low risk for early relapse.

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