Chemotherapy drug arsenic trioxide had a significantly better event-free survival for patients with acute promyelocytic leukemia (APL).
Positive results of a phase III cancer clinical trial in an uncommon form of leukemia were released today. The results showed that adult patients with previously untreated acute promyelocytic leukemia (APL) who had standard chemotherapy to induce remission of their disease, and then received the chemotherapy drug arsenic trioxide to maintain remission, had a significantly better event-free survival (more patients free of leukemia) and better overall survival than those who received only standard chemotherapy . The trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and was led by one of its Cooperative Clinical Trials Groups ? the Cancer and Leukemia Group B (CALGB).
?The positive result in a clinical trial of a common element holding an uncommon disease in remission for a significant period of time is very encouraging,? said NIH Director Elias A. Zerhouni, M.D.
Acute promyelocytic leukemia, an uncommon subtype of acute myeloid leukemia (AML), accounts for approximately 10 percent of AML cases, or about 1,500 cases per year, in the United States. It is most often diagnosed in young and middle aged adults, but it also occurs in children and older adults. Standard chemotherapy regimens produce complete remission rates of approximately 70 percent and show a five-year survival without the recurrence of disease in 35 to 45 percent of patients.
“Achieving success in a clinical trial for a rare cancer is a difficult task due to the limited number of patients eligible to enroll in the trial, so this is very encouraging news for all patients with this form of leukemia,” said NCI Director John Niederhuber, M.D. “This positive outcome demonstrates, yet again, the benefits of clinical trials and will hopefully serve as encouragement for others to join such trials.”