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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, 04/13/09

Stewart JSW et al. – Study reports that patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), while responses with gefitinib were seen, neither gefitinib 250 nor 500 mg/day improved overall survival vs methotrexate (MTX).

Methods

Aim was to compare survival in pts with recurrent or metastatic SCCHN treated with gefitinib 250 or 500 mg/d or standard MTX
486 pts, randomly assigned to:
- oral gefitinib 250 mg/day
- gefitinib 500 mg/day
- or methotrexate 40 mg/m2 intravenously weekly
Primary end point: overall survival
Secondary end points: objective response rate (ORR), safety, symptom improvement, and quality of life (QOL)
Exploratory end points: association of efficacy with EGFR gene copy number and other biomarkers

Results

Neither gefitinib 250 nor 500 mg/d improved OS vs MTX
In the gefitinib 250 mg/d, 500 mg/d, and MTX groups, respectively, median OS was 5.6, 6.0, and 6.7 mo
ORRs were 2.7%, 7.6% and 3.9%
No difference between either gefitinib arm and MTX
No unexpected AEs, except for tumor hemorrhage-type events with gefitinib
QOL improvement rates were 13.4%, 18.0%, and 6.0% for gefitinib 250 mg/d, 500 mg/d, and MTX, respectively

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