Drug Shortages Delay Cancer Clinical Trials

Extract

The mean survival time for people older than 60 years with acute myeloid leukemia (AML) is about 7 months. Only 15% survive 5 years or longer, and that percentage hasn’t changed in decades.

The poor prognosis for these patients is due in part to the fact that many cannot tolerate the toxic chemotherapy used as first-line treatment, a combination of cytarabine and daunorubicin. Both are generic intravenous drugs that have been around since the 1960s, with severe cardiovascular and other side effects. That’s why clinicians were hopeful when a small phase II trial offered preliminary evidence that clofarabine, a less toxic drug that the U.S. Food and Drug Administration approved in 2004 for acute lymphoblastic leukemia in children, had extended life in older AML patients by 3 months.

The Eastern Cooperative Oncology Group launched a major trial to definitively test the comparability or superiority of the less toxic regimen. “Try giving a person over 70 heavy chemo; one in six dies within the first 30 days,” said the Mayo Clinic’s James M. Foran, M.D., principal investigator in a National Cancer Institute–funded phase III trial comparing clofarabine to the standard regimen. The goal is to show that clofarabine has at least comparable, if not better, survival rates.