The drug Imatinib mesylate, more commonly known as Gleevec ( Europe: Glivec ), proves safe and effective over the long term in patients with an advanced form of chronic myeloid leukemia ( CML ).
A team of researchers followed 454 patients with chronic-phase chronic myeloid leukemia taking Imatinib for more than six years.
Prior to enrollment, all study participants had experienced either treatment failure or intolerance with Interferon alpha, which was the standard of care for chronic myeloid leukemia at the time the study was initiated.
Imatinib dosage began at 400 milligrams per day and was escalated to 600 mg/d or 800 mg/d in patients who did not achieve positive treatment responses within set time periods or whose disease relapsed.
A complete cytogenetic response, which is the elimination of the genetic abnormality associated with the disease, occurred in 57 percent of the study participants and was achieved in a median time of eight months.
Overall survival rates and avoidance of disease progression were strongly correlated with cytogenetic response by 12 months; those with a minimal or no cytogenetic response within the first year faired poorly.
The incidence of serious side effects was low and, although 15 cases of heart dysfunction were reported in study participants, only four cases were considered to be drug-related.
During the study, 35 patients discontinued the drug because of adverse events or abnormal test results.
This clinical trial was the basis for the first approval of Imatinib for chronic myeloid leukemia, which has since become the standard of care for the disease.
Source: American Society of Hematology, 2007