Gefitinib of no benefit in recurrent squamous cell carcinoma of head and neck

NEW YORK (Reuters Health) - Compared with methotrexate, gefitinib does not improve survival in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN), according to a report published online by the Journal of Clinical Oncology on March 16th.

"I was surprised at the lack of a survival advantage of this new agent compared to methotrexate," lead author Dr. J. Simon W. Stewart from Imperial College Healthcare NHS Trust, London, UK told Reuters Health. "I had assumed that gefitinib would have a tumor-static effect as well as a mild response rate."

Dr. Stewart and an international team compared the efficacy and safety of gefitinib (250 or 500 mg/day orally) versus intravenous methotrexate (40 mg/m2 weekly) in 486 patients with recurrent SCCHN.

At a median follow-up of 6.2 months, the authors report, overall mortality was 78.6%, with no significant difference in survival between treatment arms.

In patients with platinum-resistant disease, outcomes appeared superior in the methotrexate treatment group. Among patients not suited for platinum chemotherapy, there was no difference in the results of the treatments.

Tumor response, quality of life improvement rates, and symptom improvement rates did not differ significantly among the treatment groups, the researchers note.

Similarly, results did not differ between treatment groups when patients were analyzed according to the presence of epidermal growth factor receptor (EFGR) gene copy number or protein expression.

Tumor hemorrhage-type events were more common in the gefitinib treatment groups than in the methotrexate group, the investigators say, but interstitial lung disease events occurred with similar frequency in the 3 study arms.

"There is no evidence that gefitinib has a place in the routine treatment of SCCHN," Dr. Stewart stated.

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