Levofloxacin prophylaxis in patients with newly diagnosed myeloma

February 2020 Pharma News Jolien Blokken

Around a quarter of myeloma patients will experience a serious infection within three months after diagnosis. In a recent edition of the Lancet Oncology, results of the TEAMM study were published in which the potential benefit from antibiotic prophylaxis with levofloxacin was assessed in patients aged 21 years and older with newly diagnosed myeloma. A total number of 977 patients were randomly assigned (1:1) to receive 500 mg levofloxacin orally once daily for 12 weeks or placebo in the same regimen, with dose reduction according to estimated glomerular filtration rate every four weeks.

Follow-ups occurred at weeks 4, 8, 12, 16 and after 1 year. After a median follow-up of 12 months, 95 (19%) first febrile episodes or deaths occurred in the levofloxacin group, as compared to 134 (27%) in the placebo group (HR[95%CI]: 0.66[0.51-0.86], p= 0.0018). In de levofloxacin group, 308 (52%) serious adverse events were reported up to 16 weeks from the start of treatment, as compared to 289 (48%) in the placebo group. Tendonitis was reported in five (1%) of 489 patients in the levofloxacin group (vs. none in the placebo group) but was mostly reversible. All other serious adverse events were similar between both arms.

Overall, the addition of levofloxacin to active myeloma treatment in the first 12 weeks of therapy seems to lower the risk of febrile episodes and deaths by 34% without increasing the health care-associated infections. Patients with newly diagnosed myeloma could thus benefit from levofloxacin prophylaxis.

References

Drayson MT, Bowcock S, Planche T, et al. Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. Lancet Oncol. 2019; 20(12):1760-72.

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