This Article Full Text Full Text (PDF) Submit a related Letter to the Editor Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Copyright Permission Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Mrozek, E. Articles by Shah, M. H. Search for Related Content PubMed PubMed Citation Articles by Mrozek, E. Articles by Shah, M. H. Related Collections Thyroid Endocrine Oncology

Phase II Study of Celecoxib in Metastatic Differentiated Thyroid Carcinoma

Divisions of Hematology and Oncology (E.M., M.D.R., L.K., P.S., D.A., M.H.S.), Endocrinology, Metabolism, and Diabetes (R.T.K., M.D.R.), Nuclear Medicine (R.T.K.), and Human Cancer Genetics (M.D.R.); Departments of Internal Medicine (E.M., R.T.K., M.D.R., L.K., P.S., D.A., M.H.S.) and Radiology (R.T.K.), The Ohio State University Thyroid Cancer Unit (R.T.K., M.D.R., P.S., D.A., M.H.S.), The Ohio State University Medical Center, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, Ohio 43210; and Departments of Endocrine Neoplasia and Hormonal Disorders (M.J.K, N.B., S.I.S.), Thoracic/Head and Neck Medical Oncology (M.K.), and Diagnostic Radiology (R.M.), University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030

Address all correspondence and requests for reprints to: Manisha H. Shah, M.D., A 438 Starling-Loving Hall, 320 West 10th Avenue, Columbus, Ohio 43210. E-mail: manisha.shah{at}osumc.edu.

Context: There is increased cyclooxygenase-2 (COX-2) expression in malignant thyroid nodules compared with nonneoplastic and benign thyroid tissue.

Objective: The objective of the study was to evaluate the efficacy of celecoxib, a selective COX-2 inhibitor, in treating patients with progressive metastatic differentiated thyroid cancer (DTC) and to explore the relationship of clinical response to tumor COX-2 expression with immunohistochemistry in a subset of patients.

Design: The study was a prospective phase II trial with Fleming single-stage design powered at 80% with a 5% rejection error to detect more than 20% progression-free survival at 12 months.

Setting: Ambulatory patients were from tertiary referral academic medical centers.

Patients: Patients in the study had progressive metastatic DTC and had failed prior standard therapy.

Intervention: Patients were treated with celecoxib 400 mg orally twice a day for 12 months.

Main Outcome Measure: The main outcome measure was progression-free survival at 12 months of treatment using Response Evaluation Criteria in Solid Tumors and/or serum thyroglobulin.

Results: Twenty-three of 32 patients experienced progressive disease or stopped therapy due to toxicity, thus fulfilling the intent-to-treat study endpoint for celecoxib failure. One patient achieved partial response, and one patient completed 12 months of therapy progression-free. The patient with partial response was on therapy along with seven other patients when the study was terminated.

Conclusions: Celecoxib 400 mg orally twice per day fails to halt progressive metastatic DTC in most patients.