September 11, 2018
By Megan Brooks
NEW YORK (Reuters Health) - Levofloxacin prophylaxis significantly reduces the risk of bacteremia in children with acute leukemia receiving intensive chemotherapy, but the benefit is unclear in those undergoing stem cell transplantation (HSCT), according to a randomized controlled trial.
"The findings indicate the implementation of levofloxacin prophylaxis should be a standard component of supportive care for these leukemia patients, who are at very high risk for bacterial blood infections," said Dr. Sarah Alexander from The Hospital for Sick Kids in Toronto, Canada, in email to Reuters Health.
Bacteremia is the chief cause of illness and death in children receiving strong chemotherapy for acute myeloid leukemia (AML) and relapsed acute lymphoblastic leukemia (ALL) and for those undergoing HSCT.
Research has shown a benefit of prophylactic antibiotics in adults with neutropenia secondary to cancer therapy, but data are lacking on its value in children with cancer, researchers note in their report in JAMA September 11.
To investigate, Dr. Alexander and colleagues with the Children's Oncology Group randomly allocated 200 children with acute leukemia to receive levofloxacin prophylaxis for two consecutive cycles of chemotherapy or no prophylaxis (100 in each arm).
An additional group of children undergoing HSCT were randomized to receive levofloxacin prophylaxis during one HSCT procedure (210 children) or no prophylaxis (214 children).
In children undergoing chemotherapy, the likelihood of bacteremia was significantly lower with than without levofloxacin prophylaxis (21.9% vs. 43.4%; P=0.001). However, there was no significant reduction in bacteremia with levofloxacin among children undergoing HSCT (11.0% vs. 17.3%; P=0.06).
The researchers say it's possible that the effect of levofloxacin was similar in the chemotherapy and HSCT groups "but that there was reduced power to detect a significant difference related to fewer events among patients undergoing HSCT."
Fever and neutropenia were less common with levofloxacin. There were no significant differences between levofloxacin and control groups in severe infection, invasive fungal disease, C. difficile-associated diarrhea or musculoskeletal toxic effects at two or 12 months.
The open-label design of the study is a limitation, the authors note, and one that may have affected patient care decisions. Also, the study evaluated short-term prophylaxis and the effect of longer-term prophylaxis requires further study.
The authors note that their study included children receiving intensive chemotherapy for acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) or undergoing HSCT. "Further study is required to assess the utility of levofloxacin prophylaxis on the largest group of pediatric patients with leukemia, those undergoing primary therapy for ALL," they conclude.
The study had no commercial funding. Two study authors disclosed relationships with pharmaceutical companies.
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