Abstract

In these last ten years we have autografted 92 patients in chronic phase CML. The median age was 45 years (range, 20–65). These patients were in late chronic phase and refractory to interferon-alpha (IFN-α) (n=48) (Group A) or in early chronic phase not previously treated with IFN-α (n=44) (Group B). All these patients were treated with ICE/mini-ICE protocols and G-CSF to mobilize hematopoietic stem cells. High dose therapy consisted of TBI-conditioning regimen (n=18) or high-dose Busulfan (4 mg/kg/d for 4 days) (n=74). After engraftment, all patients received immunological therapy with IFN-α or IFN-α/IL-2, in the attempt to delay the blastic evolution. Sixty-eight (74%) patients are alive 2 to 99 months (median, 35 months) after autografting. The statistical analysis with Logrank (Mantel-Cox) test showed a significant difference in terms of survival from autografting in favor of Group B (P value 0.0079) Twenty-one patients (Group A: 17; Group B: 4) have developed blastic crisis from which all patients have died. Twenty-eight (41%) patients (Group B: 19; Group A: 9) are in compete/major cytogenetic remission at a median of 37 months (range, 9–99). One patient in Group B with HBV+ died of fulminant hepatitis 4 months after autografting; two other patients in Group A died of infections during aplasia. All patients had some degree of stomatitis that was more severe in patients of Group A. Gastrointestinal and hepatic toxicities were observed mainly in patients of Group A. Thus, autografting with Ph-negative or ≤35% Ph-positive mobilized hematopoietic progenitor cells can result in prolonged restoration of Ph-negative hematopoiesis for some patients with CML; moreover, most autograft recipients of Group B report normal or near normal activity levels, suggesting that this procedure when employed in the early phase of disease need not to be associated either with prolonged convalescence or with chronic debility.

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