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Weekly dose reduces targeted drug's side effects, but not its activity against ALL
Date:12/11/2012

e/refractory population and an overall response rate of 57 percent," O'Brien said. "The main toxicities were infusion reactions either during or shortly after infusion of the antibody. Patients developed fever sometimes associated with a drop in blood pressure. These were generally grade 1-2 so they were mild and easily treatable." The treatment was also associated with grade 1-2 elevations of transaminases, enzymes that reflect liver function, which had also occurred in the lymphoma trials.

Amended protocol

The researchers amended their protocol in an attempt to minimize toxicities. "We wondered whether we could reduce infusion reactions and liver function test elevations by giving the agent on a weekly basis instead of as a bolus every three to four weeks," O'Brien said. "The maximal plasma levels potentially would be lower, but the area under the curve might be the same because we would be giving the same total dose, just spread over three weeks."

Under the new protocol, the researchers gave the same total dose spread out over three weeks: .8 mg/m2 on Day 1 and .5 mg/m2 on Day 8 and Day 15. "We found exactly the same response rate with the weekly dose as with the monthly dose," O'Brien said. "But we did notice that the infusion reactions and the elevations in the transaminases were less frequent with the weekly schedule. This is probably because the side effects are most likely related to the peak concentrations of the drug, and when you spread it over three weeks the peak concentrations are not as high."

The Take-Away

"We observed impressive activity in a relapsed, refractory population," O'Brien said. "The toxicities were acceptable and were mainly grade 1-2 reactions to the drug itself, which is not uncommon because most antibodies are associated with mild infusion reactions. Transaminase elevations were predominately grade 1-2, and in the trial as a whole, fewer than five percent of the patients experienced gr
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Contact: Scott Merville
smerville@mdanderson.org
713-516-4855
University of Texas M. D. Anderson Cancer Center
Source:Eurekalert  

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