Celecoxib Doesn"t Improve Breast Cancer Therapy Response

NEW YORK APR 01, 2008 (Reuters Health) - Despite promising experimental findings, addition of celecoxib to exemestane therapy in postmenopausal women with advanced hormone-sensitive breast cancer does not improve response rate.

In the March 10th issue of the Journal of Clinical Oncology, Dr. Luc Yves Dirix of Oncologisch Centrum Sint-Augustinus, Wilrijk, Belgium and colleagues note that in vitro and in vivo data indicate that the combination of these two drugs has a synergistic effect.

To investigate further, the researchers conducted a phase II trial with 111 patients who had progressive disease after treatment with tamoxifen. They were randomized to therapy with exemestane 25 mg daily with or without celecoxib 400 mg twice daily.

Demographic and prognostic factors were similar in both groups and the median treatment duration was 16.1 weeks in the exemestane group and 18.3 weeks in the combination group.

Clinical benefit was observed in 48.98% of the assessable exemestane patients and 47.06% of the combination group. Clinical benefit appear to last longer in the combination group (median 96.6 versus 49.1 weeks).

Addition of celecoxib did not improve the tolerability of exemestane. Treatment was generally well tolerated and there appeared to be no untoward cardiovascular effects, but because of concerns about the safety of COX-2 inhibitors, plans for an extension trial were not pursued.

Contrary to expectations, the researchers conclude that the study "demonstrates the absence of any relevant clinical or pharmacologic interaction between celecoxib and exemestane."

In comments to Reuters Health, Dr. Dirix pointed out that "although the response rates were similar, the increased duration of response and/or clinical benefit (in the combination group) is in agreement with the antiangiogenic activity of this high dose COX-2 inhibitor in patients with cancer."

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