A phase II study of gefitinib in patients with advanced thyroid cancer.
OBJECTIVE
To determine the efficacy of gefitinib in patients with advanced thyroid cancer.


METHODS
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 Hürthle cell carcinomas (4%). The primary endpoint was overall response rate. Secondary endpoints were toxicity, progression-free survival (PFS), and overall survival (OS).


RESULTS
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.
Pennell
Nathan A
NA
Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Daniels
Gilbert H
GH
Haddad
Robert I
RI
Ross
Douglas S
DS
Evans
Tracey
T
Wirth
Lori J
LJ
Fidias
Panos H
PH
Temel
Jennifer S
JS
Gurubhagavatula
Sarada
S
Heist
Rebecca Suk
RS
Clark
John R
JR
Lynch
Thomas J
TJ
D018263:Adenocarcinoma, Follicular / Q000188:drug therapy / Q000473:pathology; D018249:Adenoma, Oxyphilic / Q000188:drug therapy / Q000473:pathology; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018276:Carcinoma, Medullary / Q000188:drug therapy / Q000473:pathology; D002291:Carcinoma, Papillary / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013954:Thyroglobulin / Q000097:blood; D013964:Thyroid Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D011799:Quinazolines; D013954:Thyroglobulin; D000077156:Gefitinib