| Abstrakt: |
Objective:To determine the efficacy of gefitinib in patients with advanced thyroid cancer.Design:In this open-label phase II trial, 27 patients with radioiodine-refractory, locally advanced, or metastatic thyroid cancer were treated with 250 mg of daily gefitinib. Histologic subtypes included papillary (41), follicular (22), anaplastic (19), medullary (15), and Hrthle cell carcinomas (4). The primary endpoint was overall response rate. Secondary endpoints were toxicity, progression-free survival (PFS), and overall survival (OS).Main outcomes:There were no objective responses among the 25 patients evaluated. After 3, 6, and 12 months of treatment, 48, 24, and 12 of patients had stable disease (SD), respectively. Median PFS and OS were 3.7 and 17.5 months, respectively. Five patients with SD had a decrease in thyroglobulin (Tg) to <90 of baseline that was maintained for at least 3 months.Conclusions:Although gefitinib therapy did not result in any tumor responses, 32 of patients had reductions in tumor volume that did not meet criteria for partial response rate. Along with falling Tg levels and prolonged SD in a subset of patients, this may indicate biologic activity. [ABSTRACT FROM AUTHOR] |
