Introduction

Nivolumab (trade name: Opdivo) has been approved in Germany since June 2017 for the treatment of squamous cell carcinoma of the head and neck in adults. The drug is an option for people who have had platinum-based chemotherapy that wasn't effective enough.

Squamous cell carcinomas of the head and neck include tumors in the following areas:

• Mouth
• Throat
• Voice box (larynx)
• Nose
• Neck
• Thyroid gland
• Ear
• Skull

They usually develop in the skin or mucous membranes and are caused by malignant changes of the upper skin cells (squamous cells).

The symptoms can vary a lot depending on the location of the tumor. In the mouth, there are usually swellings or ulcers, while tumors in the throat often cause trouble swallowing. If the larynx is affected, chronic hoarseness or a feeling of having a foreign object in the throat can occur. Head and neck cancer is more common in older people over the age of 60.

The aim of treatment with this new drug is to stimulate the immune system to fight the cancer.

Application

Nivolumab enters the bloodstream directly through a drip into a vein (an intravenous infusion). This infusion takes about 60 minutes and is given every two weeks. The exact dose depends on the person's body weight.

This treatment is stopped if severe side effects occur or if the condition gets worse despite treatment.

Other treatments

For adults with squamous cell carcinoma of the head and neck who have had treatment before, the treatment options include individually adjusted drug treatments, chemotherapy with drugs such as methotrexate, or radiation therapy. Surgery is also an option.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of nivolumab compared with the standard treatments for squamous cell carcinoma of the head and neck.

The manufacturer provided no data concerning people with squamous cell carcinomas that only progressed quite a long time after they had platinum-based chemotherapy. So it isn't clear whether nivolumab has any advantages or disadvantages in this group of people.

The manufacturer provided one study on patients with tumors that progressed very fast (already during platinum-based chemotherapy or within 6 months of it). The following results, based on the data of 171 participants, apply to this group of people: 119 people had treatment with nivolumab, while 52 patients received methotrexate.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of nivolumab (Opdivo).

Sources

• Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Nivolumab (squamous cell carcinoma of the head and neck) - Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-24. August 30, 2017. (IQWiG reports; Volume 533).

• IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

  Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. We do not offer individual consultations.

  Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.