Out-Patient Consolidation Therapy in Patients with AML by Mitoxan-trone, Etoposide and Cytarabine

Abstract

History and Goals: Now a days, the main purpose of treatment in patients with Acute Myeloid Leukemia (AML), is achiev¬ing a "definite cure", and this goal is impossible unless stem cell transplantation (bone marrow transplantation) or the ad¬ministration of high-dose Cytarabine is performed. As these therapies are very expensive and money consuming, and due to restricted application of these procedures in Iran, most hematological clinics in Iran, prefer to have a classical approach in such instances. These approaches consist of 4 cycle performing a 4 months period of hospitalization. In patients who can not pay the cost of treatment and have a low socioeconomic and cultural status, maintaining therapy is very difficult and usually unsuccessful. Out patient consolidation therapy is an alternative to cope with such problems.
Material and Methods: As a clinical trial, all cases of AML, admitted to Taleghani Hospital (Kermanshah-Iran) from De¬cember, 1998, after achieving complete remission and receiving first consolidation therapy were selected to be evaluated. For patients who could not accept long time hospitalization because of their socioeconomic, financial status, consolidation therapy was arranged for them as outpatients, for 6 continuous cycles, every 3-4 weeks. Other patients received 2 runs of classic consolidation therapy in hospital.
Findings: Till October 2002, of the 57 patients admitted with AML diagnosis, 7 cases were excluded because of advanced age (age>65) and functional weakness and 3 patients died as a result of early complications. Of the 47 remaining patients, 39 cases achieved complete remission with induction therapy. 23 of the treated patients received out-patient consolidation therapy and 16 cases underwent classical therapy. During the follow-up period which lasted between 7 to 47 months, in the classica  therapy group, 8 cases of relapse occurred leading to the death of 5 patients, whereas in the out-patient group, 12 relapses occurred in which 7 persons died. From an overall survival (OS) and disease free survival (DFS) point of view, no notable and meaningful difference was seen. But, complications of therapy necessitated blood product administration and increased amount of hospitalization, which was significantly more frequent in patients assigned to classical therapy compared to the out-patient group.
Discussion: According to the results of this study and a few identical studies performed previously in Imam Khomeini and Dr Shariati Hospitals (Tehran-Iran), although, out-patient consolidation therapy takes more time, but, because of shortened hospitalization time, ease of performance and tolerance by patients, this therapy can be applied to all patients with a low so-cioeconomic status. Moreover, from an ethical point of view, physicians can be assured that there is no difference in relapse and mortality rate compared with the classical approaches. Obviously, this therapeutic approach can be generalized and extended to other regions of Iran, and in underdeveloped coun¬tries with the same limitations and problems.