Domiciliary treatment of febrile episodes in cancer patients: a prospective randomized trial comparing oral versus parenteral empirical antibiotic treatment

Abstract

Hospitalization and empirical broad-spectrum, intravenous antibiotics are the standard treatment for febrile cancer patients. Recent evidence supports the suggestion that febrile episodes in a low-risk population can be managed successfully in an outpatient setting, but the optimal drug regimen is unknown. In a prospective randomized clinical trial we compared ciprofloxacin 750 mg p.o. twice a day with ceftriaxone 2 g i.v. as a single daily dose for the empiric domiciliary treatment of febrile episodes in low-risk neutropenic and nonneutropenic cancer patients. A total of 173 patients, accounting for 183 febrile episodes, were enrolled in the study. Overall, successful outcomes were recorded for 76 of 93 (82%) febrile episodes in patients who were randomized to the oral regimen and for 68 of 90 (75%) febrile episodes in patients randomized to the i.v. regimen: this difference was not statistically significant. The success rate was similar in all subgroups of patients: neutropenic and nonneutropenic, with documented infection and with fever of unknown origin. There were 3 deaths in the group of patients treated with the parenteral regimen, and two of these were related to treatment failure. Both treatments were well tolerated, and the cost of the oral regimen was lower. This prospective study suggests that domiciliary antibiotic empiric monotherapy is feasible in febrile nonneutropenic or low-risk neutropenic outpatients in whom a bacterial infection is suspected, and that either an oral or a parenteral regimen can be used. A number of factors may influence the choice between an orally and an i.v.-administered antibiotic, but owing to the easier administration and lower cost, the oral regimen seems to be preferable.

Outpatient parenteral antibiotic therapy in patients with haematological malignancies

“…Results of this study suggest that OPAT during the last days of an episode of fever / infection is safe and Most OPAT studies in oncology-haematology centres have primarily evaluated the efficacy of different antibiotic regimens [14,17,18]. In none of these studies was the same individual patient OPAT model used as in ours.…”

“…Recently, OPAT has also been reported from Italy [14]. One hundred and eighty-three patients with febrile episodes were randomised between oral and i.v.…”

“…Experience of OPAT in patients with haematological malignancies is still limited, but it appears also to be a safe method in this patient population [14,17,18,21]. In studies conducted so far the aims have been to assess the feasibility of early discharge with OPAT in low-risk patients [21] or to compare the efficacy of an oral antibiotic regimen with that of an i.v.…”

“…In studies conducted so far the aims have been to assess the feasibility of early discharge with OPAT in low-risk patients [21] or to compare the efficacy of an oral antibiotic regimen with that of an i.v. antibiotic regimen in patients treated as out-patients [14,17,18].…”

“…Studies have indicated that oral empirical antibiotic therapy may be safe and effective in carefully selected cancer patients who are at low risk of developing complications [8,11,13,14,17]. Empirical oral antibiotic therapy has not yet been proved to be a safe alternative in patients with AL or aggressive NHL, most of whom are at moderate or high risk of life-threatening events during the neutropenic period [16].…”