ORLANDO, FL—Treating pediatric patients newly diagnosed with acute lymphoblastic leukemia (ALL) with antibiotics throughout the induction phase reduces bacterial infections, a prospective study reported at the 57th American Society of Hematology (ASH) Annual Meeting.1
In addition, such prophylaxis does not increase fungal infections or incidence of Clostridium difficile enterocolitis, said Maria Luisa Sulis, MD, of Columbia University in New York, NY, on behalf of the Dana Farber Cancer Institute ALL Consortium.
Between 2012 and 2015, 229 patients aged 1 to 21 years with ALL were enrolled at 9 sites; 88.5% had B-ALL and 11.5%, T-ALL. Median age was 5.1 years (range, 1.0-20.9 years).
“Induction therapy, regardless of risk group, included vincristine, methylprednisolone, doxorubicin, low-dose methotrexate, and pegylated L-asparaginase,” Dr. Sulis said.
A total of 86 afebrile patients (37.5%) were “started on fluoroquinolone prophylaxis at the time of initiation of therapy and continued until count recovery at the end of induction,” she noted. For fever or documented infection, patients were switched to broad-spectrum antibiotics, such as cefepime; of the 86 who began prophylaxis, 37 (43%) subsequently developed fever. “Two afebrile patients did not receive antibiotic prophylaxis for unknown reasons.”
A total of 141 patients (61.6%) had fever at diagnosis and received broad-spectrum antibiotics “and either remained on broad-spectrum antibiotics or were switched to fluoroquinolone prophylaxis until count recovery per treating clinician,” she outlined.
The rates of infection in this study were compared to those from a predecessor study, “which included nearly identical induction chemotherapy but did not include guidelines regarding antibiotic prophylaxis or duration during induction.”
Toxicity data, available for 222 patients, showed that 38 episodes of infection occurred in 29 patients. “Age, presenting white blood cell count and immunophenotype were not associated with the development of infection,” Dr. Sulis said.
Prophylaxis with fluoroquinolones decreased the rate of both Gram negative and Gram positive infections. Compared with the previous study, the proportion of patients experiencing an infection was significantly lower (26.6% vs 13.5%; P < .0001), which was associated with decreased incidence of bacterial infection (24.7% vs 10.5%; P < .0001).
There were significantly fewer episodes of bacteremias due to Gram negative rods (P < .0001), S. aureus (P = .0006) and S. viridans (P = .02) compared with the previous study. No significant difference was observed in incidence of fungal infection (4.4% vs 3.9%, P = 0.35).
Nineteen (8.3%) patients developed C. difficile enterocolitis during induction; 15 were grade 2, 3 were grade 3, and 1 was grade 4.
In this study, induction death rate was 0.9%, compared with 2% for the previous study (P = .34).
“Larger, randomized studies are necessary to confirm the safety and efficacy of this approach during the induction phase,” Dr. Sulis concluded.
1. Sulis ML, Blonquist TM, Athale UH, et al. Effectiveness of antibacterial prophylaxis during induction chemotherapy in children with acute lymphoblastic leukemia. Oral presentation at: 57th American Society of Hematology (ASH) Annual Meeting; December 6, 2015, Orlando, FL.