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Phase I Clinical Trials in 56 Patients with Thyroid Cancer: The M. D. Anderson Cancer Center Experience

Department of Investigational Cancer Therapeutics, The Phase I Clinical Trials Program (A.M.T., D.H., J.W., A.N., S.T., R.K.), and Departments of Biostatistics (S.W.), Diagnostic Radiology (C.N.), Endocrine Neoplasia (N.B., S.I.S.), and Gynecologic Medical Oncology (M.M.), The University of Texas M. D. Anderson Cancer Center, and Department of Internal Medicine (C.V.), The University of Texas Medical School at Houston, Houston, Texas 77030

Address all correspondence and requests for reprints to: Apostolia-Maria Tsimberidou, M.D., Ph.D., Department of Investigational Cancer Therapeutics, Unit 455, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas 77030. E-mail: atsimber{at}mdanderson.org.

Introduction: Thyroid cancer is the most common endocrine malignancy. The outcomes of patients with relapsed thyroid cancer treated on early-phase clinical trials have not been systematically analyzed.

Patients and Methods: We reviewed the records of consecutive patients with metastatic thyroid cancer referred to the Phase I Clinical Trials Program from March 2006 to April 2008. Best response was assessed by Response Evaluation Criteria in Solid Tumors.

Results: Fifty-six patients were identified. The median age was 55 yr (range 35–79 yr). Of 49 patients evaluable for response, nine (18.4%) had a partial response, and 16 (32.7%) had stable disease for 6 months or longer. The median progression-free survival was 1.12 yr. With a median follow-up of 15.6 months, the 1-yr survival rate was 81%. In univariate analysis, factors predicting shorter survival were anaplastic histology (P = 0.0002) and albumin levels less than 3.5 g/dl (P = 0.05). Among 26 patients with tumor decreases, none died (median follow-up 1.3 yr), whereas 52% of patients with any tumor increase died by 1 yr (P = 0.0001). The median time to failure in our phase I clinical trials was 11.5 months vs. 4.1 months for the previous treatment (P = 0.04).

Conclusion: Patients with advanced thyroid cancer treated on phase I clinical trials had high rates of partial response and prolonged stable disease. Time to failure was significantly longer on the first phase I trial compared with the prior conventional treatment. Patients with any tumor decrease had significantly longer survival than those with any tumor increase.