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Fosbretabulin did not double survival time among patients with ATC

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Patients with anaplastic thyroid cancer treated with fosbretabulin had a survival rate comparable with those patients treated with infusion of paclitaxel, according to the findings from a new phase-2 trial.

Researchers enrolled 26 patients to determine the safety and efficacy of fosbretabulin, the effect of fosbretabulin on the natural history of anaplastic thyroid cancer and the prognostic value of serum soluble intracellular adhesion molecule-1.

Patients were assigned to a 10-minute IV infusion of 45 mg/m² of fosbretabulin for three weeks on days one, eight and 15.

Thirty-five percent of patients had grade-3 toxicity, and 4% of patients had grade-4 toxicity. Twelve percent of patients experienced grade-3 tumor pain, and 4% of patients experienced grade-4 tumor pain.

At six months, overall survival was 34%; at 12 months, overall survival was 23%, according to the researchers. Median survival was 4.7 months (95% CI, 2.5-6.4). Event-free survival was 23.1% at three months and 7.7% at six months.

Three patients were alive at the last follow-up with survival of 12.1 months, 24.4 months and 37.9 months. Patients with stable disease (n=7) had a median survival of 12.3 months (range, 4.4-37.9 months), according to the researchers. Among tertiles of baseline serum soluble intracellular adhesion molecule-1 levels, there was a significant difference in event-free survival (P<.009).

Adverse effects included mild nausea, vomiting and headache, and all resolved within 24 hours of treatment, according to the researchers.

“Fosbretabulin had an acceptable safety profile in patients with advanced anaplastic thyroid cancer, and one-third survived more than six months,” the researchers wrote. “Despite a small sample size, low baseline serum soluble intracellular adhesion molecule-1 levels were predictive of event-free survival.”

“Further prospective validation of serum soluble intracellular adhesion molecule-1 as a therapeutic biomarker and further exploration of combination regimens with fosbretabulin are warranted,” they added.

Mooney CJ. Thyroid. 2009;doi:10.1089/thy.2008.0321.