Speaker: Biju George, MD, Hematologist/Oncologist, Hematology Department, Christian Medical College, Vellore, Tamil-nadu, India
An open-label study resulted in long-term hematological and molecular remission in more than 75% of adults and children with newly diagnosed acute promyelocytic leukemia (APML) who were treated with arsenic trioxide (Trisenox®, cti) alone.
Between 1997 and 2004, 58 patients who were unable to receive all-trans retinoic acid (ATRA)-based therapy were given arsenic trioxide. In an effort to induce remission, the investigators administered arsenic trioxide 10 mg/day to the adults and 0.15 mg/kg per day to the children until complete hematological remission was achieved for a maximum of 60 days. This was followed by a single course of consolidation therapy lasting 28 days, one month after the remission was achieved. Maintenance therapy was administered for 10 days every month for six months. Hydroxyurea was used to stabilize white blood cell counts.
The response to arsenic trioxide was evaluable in 49 patients. Nine patients died less than two weeks after treatment began. Forty-seven patients (95%) in the evaluable group achieved hematological remission. The two patients who did not achieve remission died during the third week of therapy, one from intracranial bleeding and the other from bacterial sepsis. One patient who did achieve hematological remission died of fungal pneumonia on day 60. Forty-six patients received subsequent courses of arsenic trioxide.
At a median follow-up of 23 months, four patients experienced a relapse; of these, three patients achieved a second remission with arsenic trioxide and ATRA. At the time of this writing, 45 patients (77.5%) were alive and in molecular remission, with a leukemia-free survival rate of 93.3%.
Imatinib Mesylate in Newly Diagnosed Chronic Myeloid Leukemia
Speaker: Francois Guilhot, MD, Professor and Head, Oncology, Hematology, and Cell Therapy Department, Centre Hos-pitalier Universitaire, La Miletrie, Poitiers, France
Patients with newly diagnosed chronic myeloid leukemia (CML) who were treated early with imatinib mesylate (Gleevec®, Novartis) were more likely to achieve complete cytogenetic responses (CCRs), resulting in the elimination of leukemic cells and in an improvement of long-term, progression-free survival.
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Long-term data were assessed from the International Randomized Interferon vs. ST I 571 study (IRIS), the largest clinical trial of CML ever conducted. The study enrolled 1,106 patients from 117 centers in 16 countries from June 2000 to January 2001. The patients were randomly selected to receive imatinib or interferon plus cytosine arabinoside (ara-C) (Depo-Cyt®, Chiron/SkyePharma). Initial findings demonstrated that imatinib was significantly superior to interferon plus ara-C in these patients.
In a long-term, 42-month follow-up, 98% of these patients receiving imatinib achieved complete hematological responses (CHRs), 91% had major cytogenetic responses (MCRs), and 84% achieved CCRs. For the patients achieving CCRs and a thousand-fold or greater reduction in Bcr/Ab1 transcript levels (a molecular response, at 12 months), the progression-free survival rate at 42 months was 98%. For the patients who did not achieve CCRs, the survival rate was 74%.
At the 42-month follow-up, the responses to imatinib were durable. Approximately 91% of the patients continued to achieve CHRs, 91% maintained MCRs, and 87% of patients had CCRs. The overall survival rate, based on the number of CML-related deaths, was 97% for the patients treated with ima-tinib. online pharmacy uk
Patients taking imatinib as first-line therapy who achieved CCRs within 12 months of treatment had a progression-free survival rate of 93% at 42 months. Patients who did not achieve CCRs had a progression-free survival rate of 74%.