The treatment, lapatinib (Tykerb®, GSK) is being tested in 680 patients in the advanced stages of the disease. Lapatinib has already been investigated in breast cancer treatment. The drug works like no other current cancer treatment. It blocks two proteins on the surface of cancer cells that are involved in cancer growth. These proteins, called ErbB1 and ErbB2, are involved in normal cell growth but are over-active in head and neck cancer. Lapatinib reduces their activity.

Head and neck cancer is the sixth most common type of cancer worldwide. Around 600,000 people are diagnosed with the disease every year. Around two-thirds are diagnosed with advanced disease.

The new trial, including centres in the US and the European Union, will investigate the effectiveness of oral lapatinib in high-risk patients who have had surgery and are being treated with chemotherapy and radiotherapy. Results are expected in 2008.

The trial’s principal investigator Professor Jean Bourhis, Head of Radiation-Oncology Department at the Institute Gustave Roussy in France, said: “There is a clear need for new treatments in this disease area as around 50% of advanced cases relapse in a few years following classical treatments.”

The trial start was announced this week at the European Society for Therapeutic Radiology and Oncology (ESTRO)’s 1st International Meeting on Innovative Approaches in Head and Neck Oncology, Barcelona, Spain, where the results from a Phase I dose-escalation study (500- 1,500 mg/day) in 31 head and neck cancer patients were presented. The trial identified the 1,500 mg/day dose of lapatinib with chemotherapy and radiotherapy as the optimal dose in the adjuvant setting. The Phase I trial showed that 89% of patients had a response to this combination at this dose1. The most common side effects in the Phase I study were mouth ulcers (87%), radiation skin injury (65%), nausea (61%), swallowing difficulties (52%) and vomiting (52%).

Paolo Paoletti, Senior Vice-President, Oncology Medicine Development Centre, GSK, said: “Lapatinib may represent a new treatment approach to difficult-to-treat tumour types such as head and neck cancer, offering hope to patients in need of a further treatment option.”

Lapatinib was discovered and developed by GSK. It has proven effective in advanced breast cancer. The drug has yet to be approved for marketing by regulatory authorities, though marketing approval has been submitted in the US, European Union and Switzerland for the treatment of advanced breast cancer.

1. El-Hariry I, Harrington K, et al. A phase I, open-label study (EGF 100262) of lapatinib plus chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Oral presentation, 1st International Meeting on Innovative Approaches in Head and Neck Oncology, Barcelona, Spain, 22nd-24th February, 2007

Written by: Rhonda Siddall
Freelance Medical Journalist
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