Many hospitals lack key treatment for acute promyelocytic leukemia
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Less than one-third of hospitals had access to the life-saving agent all-trans retinoic acid for patients with acute promyelocytic leukemia, according to study results published in Journal of the National Comprehensive Cancer Network.
“As leukemia physicians at a tertiary care academic hospital, we receive requests for the transfer of care of patients with leukemia from other regional hospitals. When discussing the clinical background of the patient with the referring provider, we discuss whether a clinical or pathologic concern exists for acute promyelocytic leukemia [APL]. If so, we review whether all-trans retinoic acid [ATRA] has been initiated while awaiting transfer,” Dale L. Bixby, MD, PhD, researcher at University of Michigan Medical School, told Healio. “We often hear from the referring providers that ATRA is not available. After hearing this repeatedly, we began to wonder how common the lack of ATRA availability is for patients with a possible diagnosis of APL in hospitals around the United States.”
Bixby and colleagues conducted a phone survey of 120 randomly selected hospitals across the U.S. to assess the availability of ATRA and factors associated with limited access to the agent.
“NCCN guidelines for the care and management of patients with acute myeloid leukemia indicate that for patients with clinical or morphologic concerns for APL, ATRA should be immediately initiated to lower the risk [for] complications from disseminated intravascular coagulopathy,” Bixby said. “Prior studies have show that when administration of ATRA is delayed for patients suspected of having APL, there is an increased risk [for] early hemorrhagic death.”
Nevertheless, among the hospitals surveyed, only 31% had ATRA in stock. Of those that treated patients with APL, 58% had ATRA in stock, compared with 14% of hospitals that referred patients with APL. The size of the hospital did not affect the availability of ATRA, nor did its status as academic vs. nonacademic (53% vs. 31%).
Researchers found that the main reasons for lack of availability of ATRA included that the agent had not been recently requested, the inpatient pharmacist was not familiar with it, or the facility relied on hospitals or cancer centers to provide it.
“We hope that this manuscript will shed a light on the lack of availability of ATRA at many hospitals and spur a discussion by hematologists and medical oncologists with their formulary committees to increase access to ATRA and, hopefully, minimize unnecessary deaths due to the lack of availability of this important medication,” Bixby said. “The final connection would be demonstrating an increased mortality in [patients with APL] who present to hospitals that do not have ATRA on their formulary compared with hospitals that do have ATRA immediately available for their patients.”
Bixby and colleagues are interested in identifying mechanisms for the FDA to consider expanding the indication for ATRA.
“This medication has been utilized in many front-line treatment protocols for the care and management of [patients with APL] for at least 25 years, yet the current FDA approval for ATRA is only for patients who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated,” Bixby said. “The lack of this FDA indication may hamper clinical availability of this medication and limits the ability of pharmaceutical manufacturers from assisting patients in obtaining front-line access. If the FDA could review the labeled indication of some older chemotherapeutics, including ATRA, and align these indications with current comprehensive guidelines, this may also improve access to this important medication.”
For more information:
Dale L. Bixby, MD, PhD, can be reached at University of Michigan Medical School, F4811A University Hospital South, 1500 E. Medical Center Drive, Ann Arbor, MI 48109; email: dbixby@umich.edu.
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