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(Drug information on ciprofloxacin) (Cipro) plus clindamycin(Drug information on clindamycin) with an IV regimen of aztreonam(Drug information on 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 infections.
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 said.
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.