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.
"It's a win-win situation for the most common complication
of cancer treatment, achieving better patient outcomes at a lower
cost," he said, although exact cost comparisons between inpatient
and outpatient settings have not been done.
The studies were conducted as part of M.D. Anderson's Ambulatory
and Supportive Care Oncology Research Program (ASCORP). Dr. Rubenstein
is director of ASCORP, chief of General Internal Medicine, and
medical director of the Ambulatory Treatment Center.
In the first randomized, stratified trial (ASCORP-I), Dr. Rubenstein's
research team compared oral doses of ciprofloxacin (Cipro) plus
clindamycin with an IV regimen of aztreonam (Azactam) plus clindamycin.
In ASCORP-II, they compared the same IV drug regimen with a reduced
dose of oral ciprofloxacin and Augmentin (amoxicillin and potassium
clavulanate). Patients were being treated for solid tumors or
leukemia, most with profound neutropenia and many with prior documented
All patients were initially evaluated in the Ambulatory Treatment
Center, which is open around the clock. They received their first
dose at the Center and were observed for several hours. If stable,
they were sent home and instructed to return the next day. Those
with the IV regimen were to contract with a local home infusion
therapy 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. Rubenstein
He noted that the oral segment of the trial had to be stopped
early because of four unexpected cases of acute renal failure,
only one of which required dialysis. No patients were admitted
to the hospital for septic shock or required ICU care.