Sorafenib shows some benefit in head and neck cancer

NEW YORK (Reuters Health) - In chemotherapy-naive patients with metastatic or recurrent squamous cell carcinoma of the head and neck, single-agent therapy with sorafenib may be beneficial, a phase II trial has shown.

"Even thought the response rate was low, the disease control rate appears favorable. It appears that sorafenib may provide some benefit, likely for a specific subgroup of patients," lead author Dr. Stephen K. Williamson told Reuters Health by e-mail.

In a phase II trial, Dr. Williamson of the University of Kansas Medical Center, Westwood, and colleagues treated 41 patients with sorafenib, giving 400 mg twice daily p.o. in ongoing 28-day cycles.

Therapy continued until disease progression, unacceptable toxicity, significant symptomatic deterioration, a treatment delay of greater than four weeks, or patient request.

The confirmed partial response rate was 2%, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, i.e., a 30% decrease in the sum of the longest diameter of target lesions. There was an unconfirmed partial response rate of 7%.

The disease control rate was 51%, however. The median progression-free survival was 4 months, and the median overall survival was 9 months.

In their May 24th online paper in the Journal of Clinical Oncology, the investigators point out that "it is now generally accepted that potential benefit from this agent and from other targeted agents that have a cytostatic rather than cytotoxic mechanism of action may not be ideally correlated (with) response rates." In other words, sorafenib might provide a clinical and statistical benefit without producing significant response rates.

The authors said the rates of disease control, progression-free survival, and overall survival in this trial are encouraging.

Dr. Williamson added, "We would hope that our pending molecular correlative analysis might give clues as to which patients may be likely to benefit and lead to further clinical evaluation of this agent in a subset of head and neck cancer patients."

http://jco.ascopubs.org/cgi/content/abstract/JCO.2009.25.6834v1

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