NEW YORKAn ongoing trial of thalidomide(Drug information on thalidomide) (Thalomid) in patients with aggressive, advanced papillary and follicular thyroid carcinomas produced an early response rate of 76%, according to a report presented at the Mount Sinai School of Medicine Chemotherapy Foundation Symposium XX.
The trial is enrolling patients with distant metastases from medullary thyroid carcinomas as well as papillary and follicular thyroid cancers unresponsive to radioiodine therapy, reported Kenneth B. Ain, MD, professor of medicine and director, Thyroid Nodule & Oncology Clinical Service, University of Kentucky.
To be eligible for the study, patients must have a 30% increase in tumor volume in the preceding year; the distant tumor sites must be unresectable; and patients must not have previously taken thalidomide or be pregnant.
Under the protocol, patients are started on 200 mg thalidomide taken daily at bedtime. After 2 weeks, the dosage is increased to 400 mg/d and patients are asked about compliance and toxicity. "Then they are rapidly titrated to either 800 mg a day or their maximum tolerated dose," Dr. Ain said. "Sometimes, the dose is reduced if they have grade 3 side effects, but ultimately we get them on a stable dose."
The goal is to have 25 evaluable patients with papillary and follicular thyroid carcinoma and 25 with medullary disease. At the time of the preliminary analysis reported by Dr. Ain, 17 patients with papillary and follicular cancers were evaluable. The medullary cancer group had 6 evaluable patients.
Initial evaluation of treatment effect was performed with digitalized CT scans of tumor mass 2 months after patients began the protocol. "If there was a positive response as denoted by tumor stabilization or decrease, or dramatic reduction in growth rate," Dr. Ain said, "they were continued on thalidomide and re-evaluated every 2 months." If disease progression was noted, they were dropped from the study.