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Phase III study of gefitinib 250 compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck
Journal of Clinical Oncology, 03/26/09

Stewart JSW et al. - In a trial to compare survival in pts with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with gefitinib 250 or 500 mg/day or standard methotrexate, it was concluded that in pts with recurrent or metastatic SCCHN, while responses with gefitinib were seen, neither gefitinib 250 nor 500 mg/day improved overall survival (OS) compared with methotrexate. With the exception of tumor hemorrhage–type events with gefitinib, adverse event profiles were generally consistent with those previously observed.

Methods

486 pts with recurrent SCCHN were randomly assigned to oral gefitinib 250 mg/day, gefitinib 500 mg/day, or methotrexate 40 mg/m2 IV wkly.
Primary endpoint was OS; secondary endpoints were objective response rate (ORR), safety, symptom improvement, and quality of life (QOL).
Exploratory endpoints included association of efficacy with epidermal growth factor receptor gene copy number and other biomarkers.

Results

Neither gefitinib 250 nor 500 mg/day improved OS compared with methotrexate.
In the gefitinib 250 mg/day, 500 mg/day, and methotrexate groups, respectively, median OS was 5.6, 6.0, and 6.7 mos; ORRs were 2.7%, 7.6% and 3.9%, with no statistically significant difference between either gefitinib arm or methotrexate.
No unexpected adverse events were observed, except for tumor hemorrhage-type events with gefitinib (8.9%, gefitinib 250 mg/day; 11.4%, gefitinib 500 mg/day; 1.9%, methotrexate).
QOL improvement rates were 13.4%, 18.0%, and 6.0% for gefitinib 250 mg/day, 500 mg/day, and methotrexate, respectively.

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