Drug Shortages Delay Cancer Clinical Trials.

T he 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 cardio-vascular 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. however, accrual to the planned 747-patient trial, which launched in January 2011, slowed sharply in the first 3 months of this year. It wasn't because patients feared being randomized to the more toxic arm. rather, the trial's 145 sites were plagued by periodic shortages of daunorubicin, one of the two drugs in the comparison arm. each of the three generic manufacturers that formulate the drug have at various points in the past year informed the FDA that they suspended or curtailed production because of " manufacturing issues, " according to the American Society of health-System Pharmacists. the drug shortage dramatically slowed accrual to the trial. the trial enrolled less than 60% of the expected number of patients in the first year, and at least one major site—memorial Sloan–Kettering Cancer Center in New york—postponed enrollment entirely after the center decided to give priority to pediatric patients for its limited supplies of daunorubicin. Clinicians who treat the 13,000 patients who get AmL each year can substitute ida-rubicin for daunorubicin in their first-line treatment. But study organizers are wary of changing protocols in the middle of their study to cope with the shortages. " …