Antibiotic May Benefit New Myeloma Patients

Newly diagnosed myeloma patients who receive antibiotic prophylaxis may have reduced mortality risk, a new study found.

The researchers noted that while significant improvements have been made in myeloma treatment, with the UK seeing a 50% five-year survival rate, about 20% of myeloma-related deaths are due to infection. The early diagnosis period is when the risk is greatest.

“Antimicrobial prophylaxis might reduce death from infections, since it has been shown to improve survival in patients with prolonged neutropenia. However, concerns about increased antibiotic resistance, drug-related side-effects, and the risk of health care-associated infections mean the use of quinolone prophylaxis remains controversial,” the authors wrote. Their findings were published in The Lancet Oncology.

The study described outcomes of the TEAMM trial. This prospective, double-blind placebo-controlled trial included newly diagnosed myeloma patients at 93 UK-based hospitals. Between Aug. 15, 2012, and April 29, 2016, patients were recruited within two weeks of treatment initiation and were randomized 1:1 to levofloxacin or placebo. They received either 500 mg of levofloxacin (two 250 mg tablets) orally once daily or two placebo tablets orally for twelve weeks. Estimated glomerular filtration rate was evaluated every four weeks for dose reduction. The main outcome measure was time to first febrile episode or all-cause mortality over 12 weeks. Patients were excluded if they had a known sensitivity or allergy to levofloxacin or other quinolones or known tendon disorder history related to fluroquinolone administration, were receiving other prophylactic antibiotic treatment (excluding pneumocystis prophylaxis) or amiodarone or arsenic trioxide, were actively receiving antiepileptic treatment, were women at risk of becoming pregnant or currently breastfeeding, had mandatory requirement for prophylactic antibiotics (except pneumocystis prophylaxis), and five-year history or concurrent active malignancies (except surgically removed basal or squamous cell carcinoma of the skin, treated carcinoma in-situ of the breast or cervix, or incidental histological finding of prostate cancer) were excluded.

Final analysis included 977 patients randomized to receive levofloxacin prophylaxis (n = 489) or placebo (n = 488) who were followed for a median (IQR) 12 (8–13) months. The rate of first febrile episode or death in the levofloxacin group was 19% (n = 95) versus 27% (n = 134) in the placebo group (hazard ratio [HR] 0.66, 95% CI 0.51–0.86, P=0.0018). During a 16-week period, a total of 597 serious adverse events (AEs) were recorded: 308 (52%) in the levofloxacin group and 289 (48%) in the placebo group. The AEs were mostly similar between groups, except the levofloxacin group presented five episodes (1%) of tendonitis, most of which were reversible.

The study authors concluded that newly diagnosed myeloma patients could greatly reduce their risk of death or febrile episodes by adding levofloxacin to their treatment regimen compared to placebo.