CHEMOPROPHYLAXIS WITH CIPROFLOXACIN IN OVARIAN-CANCER PATIENTS RECEIVING PACLITAXEL - A RANDOMIZED TRIAL

The objective of this study was to evaluate the efficacy of oral cipro floxacin in preventing febrile morbidity superimposed on the neutropen ia induced from a paclitaxel regimen in ovarian cancer patients. Eligi ble patients received paclitaxel at doses of 135 to 175 mg/m(2) alone or in combination with a platinum agent. They were randomized to eithe r an observation (control) group or a ciprofloxacin prophylaxis group. Patients in the ciprofloxacin group received 500 mg ciprofloxacin ora lly twice a day once the absolute neutrophil count (ANC) was less than 500/mm(3) and continued until the ANC was greater than 1000/mm(3). Ni nety patients were enrolled between the control (n=45) and ciprofloxac in (n=45) groups. They received 371 cycles of a paclitaxel-based regim en with 177 and 194 cycles in the control and ciprofloxacin groups, re spectively. Ciprofloxacin prophylaxis was prescribed for 138 (71%) of the cycles in the ciprofloxacin group and was given for a mean duratio n of 7.7 days per cycle. The groups were similar in disease status and risk factors for neutropenia. Fifteen patients in the central group d eveloped febrile neutropenia versus 12 of those in the ciprofloxacin g roup (P=0.69). The mean ANC and mean length of hospital stay for neutr openic fever were also similar between groups, There was a greater fre quency of an ANC <100 associated with those prophylaxed with ciproflox acin (P=0.01). Only 44% of the febrile episodes were associated with a positive culture. Staphylococcus aureus was the most frequently repor ted organism isolated. Considering these results, it does not appear t hat febrile neutropenia is reduced by ciprofloxacin during grade IV ne utropenia. (C) 1997 Academic Press.