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The drug Erbitux prolongs survival in patients with advanced head and neck cancer by nearly three months, according to study results announced Saturday.

"This is the first systemic treatment in 25 years to show a survival benefit over platinum-based chemotherapy" for these patients, he said.

"We have now found for the first time--in a group of patients with a very poor outcome--a survival benefit that will change practice," said Dr. Jan Vermorken, oncology professor from the University of Antwerp in Belgium, in a prepared statement. The study results were unveiled at the annual American Society of Clinical Oncology (ASCO)conference.

The study tracked 222 patients with metastatic head and neck cancer who took Erbitux with chemotherapy, and 220 patients who took chemo without Erbitux. The Erbitux patients survived an average of 10.1 months, compared to 7.4 months for patients taking chemo without the drug.

"I was hopeful for this study but I was also very skeptical," Vermorken said at a press conference Saturday morning. He noted that head and neck cancer is notoriously difficult to treat. But he said the study exceeded the goal of prolonging survival by two months.

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MEDIA ALERT – MOUTH CANCER DRUG MAY SOON BE AVAILABLE ON NHS
4th October 2007


Today, the Mouth Cancer Foundation came a step closer to making sure all Mouth Cancer patients have access to a new drug, currently not widely available on the NHS. The drug in question is called ‘Cetuximab’ and is a new cancer treatment available in Scotland since July 2006, but not England and Wales at present.

It is hoped that cetuximab in combination with radiotherapy can be used as an alternative in Mouth cancer patients for whom chemoradiotheraphy is in appropriate.

The charity successfully convinced the Appeal Panel of the National Institute for Health and Clinical Excellence (NICE) to ask its Appraisal Committee’s to reconsider its appraisal decision to ban the drug for head and neck cancer patients in England and Wales. The appraisal has now been returned to the Committee.
(click above link for pdf of the Result of the Appeal)

The Founder of the Mouth Cancer Foundation, Dr Vinod K Joshi, explained that the charity represented the views of its members constituting a wide population of patients with mouth cancer.

Four members of the Mouth Cancer Foundation, Mrs Brenda Brady, Mr John Spencer, Mrs Christine Piff and Mr Mike Cummins provided the Appeal Panel with personal accounts of the suffering caused by head and neck cancer and of the very unpleasant nature of their treatments. They stressed that it was important for the Institute to take patients’ views into account.

This the Appeal Panel did, and the debate centred on the efficacy of cetuximab. Currently both carboplatin and cisplatin are used for chemoradiotheraphy in the United Kingdom with horrific side effects. Carboplatin had fewer adverse effects than cisplatin, but was more likely to suppress the bone-marrow. Therefore, cisplatin was the preferred treatment. The Appraisal Committee accepted that cetuximab plus radiotherapy caused less severe adverse effects than either of the platinum-based chemoradiotherapy regimens.

The Appeal Panel considered that the Appraisal Committee had not given appropriate consideration to the issue of whether a chemoradiotherapy regimen of carboplatin alone was as effective as cisplatin, or that a regimen consisting of carboplatin plus fluorouracil would necessarily be suitable for the population identified in the decision problem in whom cisplatin was contra-indicated. The Panel found that, as a result, the Committee's conclusions were perverse in proposing a ‘carboplatin-based’ regimen for those in whom cisplatin was contra-indicated.

The Founder of the Mouth Cancer Foundation, Dr Vinod Joshi says “The Mouth Cancer Foundation is delighted that the decision has been referred back the Final Appraisal Determination to the Committee for reconsideration”.

Interviews Available: Founder of the Mouth Cancer Foundation Dr Vinod Joshi

To set up an interview please call Media Ambitions on 020 7482 3600

• Cetuximab in combination with radiotherapy is recommended as a treatment option only for patients with locally advanced squamous cell cancer of the head and neck whose Karnofsky performance-status score is 90% or greater and for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated.
  
• People currently receiving cetuximab in combination with radiotherapy for the treatment of locally advanced squamous cell cancer of the head and neck who do not meet the criteria outlined in section 1.1 should have the option to continue therapy until they and their clinicians consider it appropriate to stop

• UK's NICE backs ImClone's Erbitux, changes tack Reuters - USA
  Vinod Joshi of the Mouth Cancer Foundation said the about-turn by NICE was a "happy day" for patients since Erbitux, known generically as cetuximab, ...