NEW YORKAn ongoing trial of 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
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.