Immunotherapy Doubles Head and Neck Cancer Survival

Nivolumab - an immunotherapy drug greatly improves survival for patients with relapsed head and neck cancer - a disease which is notoriously difficult to treat, find scientists.

More than double the number of patients taking nivolumab were alive after one year as those treated with chemotherapy, reported the major international trial, published today (Sunday) in the New England Journal of Medicine.

Head and Neck Cancers - Types, Risk Factors, Symptoms, Diagnosis, Treatments
Head and neck cancers usually occur in the squamous cells lining the moist, mucosal surfaces inside the head and neck.

‘Nivolumab - an immunotherapy drug became the first treatment to extend survival in a phase III clinical trial for patients with head and neck cancer in whom chemotherapy had failed - and it did so with fewer side-effects than existing therapeutic options.’

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There are currently no other treatment options that improve the survival of patients with cisplatin-resistant relapsed or metastatic head and neck cancers. This group of patients are expected to live less than six months.

The trial was led in the UK by Professor Kevin Harrington of The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, and involved 20 research organisations from around the world. It was funded by Bristol Myers Squibb.

Of the 361 patients in the trial, 240 with relapsed or metastatic head and neck cancer were allocated to receive nivolumab and 121 to one of three different chemotherapies. UK patients received the chemotherapy drug docetaxel, which is the only treatment approved for advanced head and neck cancer by NICE.

Quiz on Head and Neck Cancer
Head and neck cancers begin in squamous cells that line the moist, mucosal surfaces inside the head and neck. These kinds of cancers related to squamous cells are referred to as squamous cell carcinomas.

Cancers of head and neck are further differentiated by the area of head and neck in which they begin. This form of cancer starts in lip, oral cavity (mouth), nasal cavity, paranasal sinuses, pharynx and larynx.

Facility Volume and Radiation Outcomes for Head and Neck Cancers Linked
Relationship between higher-volume treatment centers and improved overall survival for head and neck cancers identified by Yale Cancer Center team researchers.

Cancers in brain, eye, esophagus, thyroid gland, scalp, muscles and bones of head and neck are not categorized under head and neck cancers. In some cases, squamous cells can be found in lymph nodes of upper neck when there is no evidence of cancer in other parts of head and neck. If this happens, cancer is called metastatic squamous neck cancer with unknown (occult) primary.

After one year of the study, 36 per cent of patients treated with nivolumab were still alive compared with 17 per cent for the comparator arm.

Median survival for patients on nivolumab was 7.5 months, compared with 5.1 months for chemotherapy.

Chronic Sinusitis may Increase Risk of Certain Subtypes of Head and Neck Cancers
Chronic sinusitis-related inflammation and immunodeficiency play a role in the development of certain subtypes of head and neck cancers.

The survival benefit was more pronounced in patients whose tumours had tested positive for human papillomavirus (HPV). These patients survived an average of 9.1 months with nivolumab and 4.4 months with chemotherapy.

HPV-negative patients survived an average of 7.5 months with nivolumab and 5.8 with chemotherapy.

Importantly, fewer patients experienced serious side-effects from taking nivolumab than with conventional treatment - only 13 per cent compared with 35 per cent of patients who received chemotherapy.

Patients given chemotherapy reported feeling physically, socially and emotionally worse off, whereas those who were given nivolumab remained stable during the course of treatment.

Professor Harrington will be presenting some of the findings at the European Society for Medical Oncology 2016 Congress in Copenhagen, simultaneously with publication.

Nivolumab will still have to go through approval by the European Medicines Agency and NICE before it is available for head and neck cancer patients on the NHS.

UK trial lead Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant at The Royal Marsden NHS Foundation Trust, said:

"Nivolumab could be a real game-changer for patients with advanced head and neck cancer. This trial found that it can greatly extend life among a group of patients who have no existing treatment options, without worsening quality of life.

"Once it has relapsed or spread, head and neck cancer is extremely difficult to treat. So it's great news that these results indicate we now have a new treatment that can significantly extend life, and I'm keen to see it enter the clinic as soon as possible."

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said:

"Nivolumab is one of a new wave of immunotherapies that are beginning to have an impact across cancer treatment. This phase III clinical trial expands the repertoire of nivolumab even further, showing that it is the first treatment to have significant benefits in relapsed head and neck cancer.

"We hope regulators can work with the manufacturer to avoid delays in getting this drug to patients who have no effective treatment options left to them."

Source-Eurekalert