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Prophylactic levofloxacin reduces infection and death risk in myeloma patients: TEAMM trial

Prophylactic levofloxacin reduces infection and death risk in myeloma patients: TEAMM trial

UK: Addition of prophylactic levofloxacin to active myeloma treatment during the first 12 weeks of therapy (after the diagnosis) reduces the risk of early death and infection, according to a recent study. Results of the TEAMM trial, published in The Lancet Oncology journal, suggests that prophylactic levofloxacin could be used for patients with newly diagnosed myeloma undergoing anti-myeloma therapy.

“To our knowledge, this is the first double-blind randomised placebo-controlled trial of antibiotic prophylaxis in patients with myeloma and the first trial to show improved survival and reduced infections,” write the authors.

According to Mayo Clinic, multiple myeloma is cancer that forms in a type of white blood cell called a plasma cell. Plasma cells help to fight infections by making antibodies that recognize and attack germs.  causes cancer cells to accumulate in the bone marrow, where they crowd out healthy blood cells. Rather than produce helpful antibodies, the cancer cells produce abnormal proteins that can cause complications.

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“Substantial advances in the myeloma treatment have improved survival to 50% at 5 years, however, infection contributes to death in a fifth of myeloma patients. The risk of infection is highest in the first 3 months after the diagnosis and contributes to half of the early mortality,” write the authors. Early mortality still remains a problem despite some reduction in early deaths with the use of novel anti-myeloma agents.

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 healthcare-associated infections mean the use of quinolone prophylaxis remains controversial.

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Mark T Drayson, University of Birmingham, Birmingham, UK, and colleagues aimed to assess whether antibiotic prophylaxis would be beneficial for patients newly diagnosed with myeloma in preventing infection in the TEAMM trial. They also investigated the effect of antibiotic-resistant organism carriage and healthcare-associated infections in patients with newly diagnosed myeloma.
TEAMM was a prospective, multicentre, double-blind, placebo-controlled randomised trial in patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals. All enrolled patients were within 14 days of starting active myeloma treatment.  977 patients were randomized to receive either 500 mg of levofloxacin (two 250 mg tablets), orally once daily for 12 weeks or placebo tablets (two tablets, orally once daily for 12 weeks) in the ratio 1:1.
The primary outcome was time to first febrile episode or death from all causes within the first 12 weeks of trial treatment.
Key findings of the study include:
  • 95 (19%) first febrile episodes or deaths occurred in 489 patients in the levofloxacin group versus 134 (27%) in 488 patients in the placebo group (hazard ratio 0·66).
  • 597 serious adverse events were reported up to 16 weeks from the start of trial treatment (308 [52%] of which were in the levofloxacin group and 289 [48%] of which were in the placebo group).
  • Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group.

The results of this study suggest that the benefits of levofloxacin prophylaxis outweigh the perceived risks in patients with newly diagnosed myeloma.

“The study found a consistent benefit for the use of levofloxacin prophylaxis over 12 weeks in patients with newly diagnosed myeloma, without any increase in healthcare-associated infections. Thus, patients with newly diagnosed myeloma could benefit from levofloxacin prophylaxis, although local antibiotic resistance proportions must be considered. Prolonged antibiotic prophylaxis after 12 weeks and combined antibiotic use for prophylaxis require investigation in future studies,” concluded the study.

More Information: “Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial” published in The Lancet Oncology journal.


Journal Information: The Lancet Oncology 

Source: The Lancet Oncology

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