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A phase II trial of fosbretabulin in advanced anaplastic thyroid carcinoma and correlation of baseline serum-soluble intracellular adhesion molecule-1 with outcome
Thyroid, 03/19/09

Mooney CJ et al. - In a trial to determine the efficacy and safety of fosbretabulin in pts with advanced anaplastic thyroid cancer (ATC) and whether fosbretabulin altered the natural history of ATC by doubling median survival and to evaluate the prognostic value of serum soluble intracellular adhesion molecule-1 (sICAM), there were no objective responses seen with single-agent fosbretabulin as administered, and a doubling of survival as the primary endpoint was not seen. Fosbretabulin has an acceptable safety profile in pts with advanced ATC, and one-third survived more than 6 mos. Despite a small sample size, low baseline sICAM levels were predictive of event-free survival.

Methods

26 pts received fosbretabulin 45 mg/m2 as a 10-min IV infusion on days 1, 8, and 15 of a 28-day cycle.
sICAM levels were obtained at baseline, over the first 2 cycles, and end of therapy.
Treatment was continued until disease progression.

Results

Fosbretabulin was well tolerated; grade 3 toxicity was observed in 9 pts (35%), and grade 4 toxicity in 1 (4%).
QTc prolongation delayed treatment in 4 causing 1 to stop treatment.
Median survival was 4.7 mos with 34% and 23% alive at 6 and 12 mos, respectively.
Median duration of stable disease in 7 pts was 12.3 mos.
Baseline serum sICAM levels were measured in 24 pts with a median 253.5 ng/mL.
There was a significant difference in event-free survival among tertiles of baseline sICAM levels.

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