Phase II prospective trial of gefitinib given concurrently with cisplatin and radiotherapy in patients with locally advanced head and neck cancer.
OBJECTIVE
To examine a series of head and neck squamous cell cancer (HNSCC) patients treated with combined gefitinib and chemoradiotherapy (CRT) regarding treatment efficacy and tolerability and correlation with epidermal growth factor receptor (EGFR) factors.


METHODS
Fifteen patients with locally advanced HNSCC were included in the study. The patients were scheduled to take gefitinib 250 mg in combination with concurrent radiotherapy (RT) +/- concomitant cisplatin. EGFR expression, activation and amplification; serum vascular endothelial growth factor (S-VEGF); and microvessel density were determined.


RESULTS
Locoregional tumour control at 3 months was achieved in 79% of the patients. The treatment was reasonably well tolerated. A tendency toward a correlation between complete tumour response and EGFR amplification was observed (p = .057). Patients with activated EGFR did not have significantly more complete responses than patients with no EGFR activation (p = .10). The baseline S-VEGF levels seemed to be higher in patients with HNSCC than in 40 healthy controls (p = .076).


CONCLUSIONS
The combination of gefitinib and RT with concurrent cisplatin was feasible. EGFR amplification status may correlate with the treatment response in HNSCC patients treated by gefitinib and CRT. S-VEGF level does not seem to correlate with treatment outcome.
Saarilahti
Kauko
K
Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland.
Bono
Petri
P
Kajanti
Mikael
M
Bäck
Leif
L
Leivo
Ilmo
I
Joensuu
Timo
T
Isola
Jorma
J
Mäkitie
Antti A
AA
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D018773:Genes, erbB-1; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D007150:Immunohistochemistry; D017403:In Situ Hybridization; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D055815:Young Adult
D000970:Antineoplastic Agents; D002945:Cisplatin