MOXIFLOXACIN AS EFFECTIVE AS CIPROFLOXACIN-AMOXICILLIN/CLAVULANIC COMBINATION FOR OUTPATIENT TREATMENT OF FEBRILE NEUTROPENIA  

NEW YORK (Reuters Health) Jan 29 - Oral moxifloxacin is similar to ciprofloxacin plus amoxicillin/clavulanic combination therapy for treating fever in low-risk neutropenic patients with cancer, according to research from the European Organization for the Research and Treatment of Cancer (EORTC).

Current guidelines recommend oral ciprofloxacin plus amoxicillin/clavulanic acid as standard treatment for patients like these. Moxifloxacin offers enhanced Gram-positive antimicrobial coverage, but with more limited activity against Pseudomonas aeruginosa, compared with ciprofloxacin.

Dr. Winfried V. Kern from Universitaetsklinikum Freiburg in Germany and colleagues in the EORTC Infectious Diseases Group compared oral moxifloxacin with the standard therapy in a double-blind, randomized trial of 341 patients from 21 centers in 8 countries.

Their study, published online January 28 in the Journal of Clinical Oncology, included 333 patients in the intent-to-treat population and 338 patients in the analysis of safety.

Therapeutic success rates did not differ significantly between the moxifloxacin (80%) and combination therapy (82%) groups.

More than half the patients were afebrile by day two, and there were no significant differences between the groups in the time to defervescence, the median study drug, and total antibiotic treatment durations.

Failures in the moxifloxacin group were more likely due to persistent or breakthrough bacteremia and/or in vitro resistance (including three patients with P. aeruginosa), whereas combination therapy failures were more often due to intolerance and adverse events, according to the researchers.

Only nine (5%) of the 196 patients discharged while receiving protocol therapy were readmitted to hospital, with no difference between the treatment groups. Survival at 30 days was 99% in both treatment groups.

The two treatment groups did not differ in the rate of patients with at least one serious adverse event or with any adverse event. Diarrhea was more common in the combination therapy arm, while neurologic events were more common in the moxifloxacin group.

"Although the trial was terminated before reaching the planned sample size, the calculated confidence interval for the difference in therapy success was compatible with the definition of equivalence," the researchers write.

"All centers that choose to adopt this treatment approach should undertake surveillance for fluoroquinolone resistance and the associated multiresistant pathogens, and have access to good antimicrobial stewardship and infection control programs to stem the emergence of antimicrobial resistance," write Dr. Monica A. Slavin and Dr. Karin A. Thursky from Peter MacCallum Cancer Centre in Melbourne, Australia, in an accompanying editorial.

"Ultimately," they conclude, "the feasibility and success of such ambulatory programs will depend on the numbers of eligible patients, the appropriate institutional infrastructure and support, and patient and physician education."

Dr. Ernie Marshall, who was not involved in the study, said the new findings are consistent with previously published data. But he also noted that the study is relatively small.

"Clearly, one must be cautious in interpreting the statement of 'equivalence,'" Dr. Marshall, a consultant in medical oncology at The Clatterbridge Cancer Centre in Merseyside, UK, told Reuters Health by email.

"My conclusion would be that this research supports the concept that selected patients with low-risk febrile neutropenia can be safely identified for oral therapy and early discharge after a period of limited hospital assessment," he added. "I think that moxifloxacin should be considered an option but that the final decision should be guided by local expert microbiological advice dependent on patterns of infection and resistance."

Dr. Kern did not respond to a request for comments.

SOURCE: http://bit.ly/WrUnZZ and http://bit.ly/WrUnZZ

J Clin Oncol 2013.