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.

What are the advantages of nivolumab?

  • Life expectancy: The study suggests that nivolumab has an advantage over methotrexate in terms of life expectancy: Half of the patients who received methotrexate passed away within about 4 months. Half of the patients who received nivolumab passed away within about 7 to 8 months.
  • Severe side effects: The study indicates that severe side effects were less common during treatment with nivolumab than during treatment with methotrexate.
  • The study also indicates that inflammations of the mucous membranes are less common during treatment with nivolumab than during treatment with methotrexate.

What are the disadvantages of nivolumab?

  • Problems affecting the airways and chest: The study indicates that these side effects are more common during treatment with nivolumab than with methotrexate.
  • Headaches: The results of the study indicate that nivolumab has a disadvantage here too.

No difference

  • Treatment stopped due to side effects: There were no differences between the treatments here.
  • Diseases of the skin and subcutaneous tissue: There were no differences between the treatments in terms of these side effects either.

What remains unanswered?

There were no suitable data concerning symptoms of the disease, effects on the general state of health and health-related quality of life, as well as other side effects such as pneumonia.

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).