ATLANTA--Two studies from the University of Texas M.D. Anderson Cancer Center have shown that neutropenic fever can be safely and effectively managed on an outpatient basis in a select, low-risk group of patients, Edward Rubenstein, MD, said at the Third International Conference on Clinical Applications of Cytokines and Growth Factors in Hematology and Oncology.
ATLANTA--Two studies from the University of Texas M.D. AndersonCancer Center have shown that neutropenic fever can be safelyand effectively managed on an outpatient basis in a select, low-riskgroup of patients, Edward Rubenstein, MD, said at the Third InternationalConference on Clinical Applications of Cytokines and Growth Factorsin Hematology and Oncology.
"It's a win-win situation for the most common complicationof cancer treatment, achieving better patient outcomes at a lowercost," he said, although exact cost comparisons between inpatientand outpatient settings have not been done.
The studies were conducted as part of M.D. Anderson's Ambulatoryand Supportive Care Oncology Research Program (ASCORP). Dr. Rubensteinis director of ASCORP, chief of General Internal Medicine, andmedical director of the Ambulatory Treatment Center.
In the first randomized, stratified trial (ASCORP-I), Dr. Rubenstein'sresearch team compared oral doses of ciprofloxacin (Cipro) plusclindamycin with an IV regimen of aztreonam (Azactam) plus clindamycin.In ASCORP-II, they compared the same IV drug regimen with a reduceddose of oral ciprofloxacin and Augmentin (amoxicillin and potassiumclavulanate). Patients were being treated for solid tumors orleukemia, most with profound neutropenia and many with prior documentedinfections.
All patients were initially evaluated in the Ambulatory TreatmentCenter, which is open around the clock. They received their firstdose at the Center and were observed for several hours. If stable,they were sent home and instructed to return the next day. Thosewith the IV regimen were to contract with a local home infusiontherapy company. The treatment duration was 7 to 8 days.
ASCORP-I showed that outpatient IV therapy was safe and effective(95% response rate), and oral therapy was "promising"(88% response rate). There were no deaths or serious infections,"which suggested our approach was correct," Dr. Rubensteinsaid.
He noted that the oral segment of the trial had to be stoppedearly because of four unexpected cases of acute renal failure,only one of which required dialysis. No patients were admittedto the hospital for septic shock or required ICU care.
ASCORP-II showed that the oral regimen (90% response rate) wasas safe and effective as the IV therapy (87% response rate). Leukemiapatients on the oral regimen did not fare as well as others inthe ASCORP-II study. Toxicities such as candidiasis were verymild and self-limiting, and there were no infection-related deaths,episodes of septic shock, or admissions to the ICU.
Many of the patients in ASCORP-II were receiving cytokines orgrowth factors, and preliminary data show a "trend"toward a higher response rate to the oral regimen in patientson growth factors.
The key to the success of an outpatient strategy is the patientselection process (see below), Dr. Rubenstein said. He noted thatthe expected duration of neutropenia, ie, short (less than 7 days)or long (more than 14 days), may also separate low-risk from high-riskpatients, but this is not yet clear. In addition, he advises physiciansto be aware of local susceptibility patterns of infection.
A motivated and compliant patient with a close relationship witha family member or significant other who could be a willing caregiver.
No evidence of significant co-mor-bidity that would otherwiserequire an inpatient level of care.
Proximity to the institution.
Good liver and renal function.
From a presentation by Dr. Edward Rubenstein, M.D. Anderson CancerCenter.