Introduction

The drug axitinib (trade name: Inlyta) has been approved in Germany since September 2012 for patients with advanced renal cell cancer who have already had unsuccessful treatment with a cytokine or the drug sunitinib.

Renal cell cancer is the most common type of kidney cancer. If renal cell cancer has already grown too much or spread to other organs, surgery to remove it may no longer be an effective treatment.

Treatment with axitinib aims to inhibit further tumor growth, thus prolonging life.

Application

Axitinib is taken twice a day in the form of a tablet. One tablet contains 1 mg, 3 mg, 5 mg or 7 mg of axitinib. At first, 5 mg are taken twice a day. The dose is then adjusted individually and can be increased up to 10 mg twice a day.

Other treatments

For patients with advanced renal cell cancer who have already had unsuccessful treatment with a cytokine, the drug sorafenib is an option. After unsuccessful treatment with sunitinib, the available options are everolimus or nivolumab.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether axitinib has any advantages or disadvantages when compared with the standard treatment for people with advanced renal cell cancer who have had unsuccessful treatment with a cytokine or sunitinib.

For people who had unsuccessful treatment with sunitinib, axitinib was supposed to be compared with everolimus or nivolumab. However, IQWiG didn’t have access to any relevant studies that could be used to make this comparison. So it wasn’t possible to find out whether axitinib has any advantages or disadvantages compared with the standard treatment for this group of people.

For the group of people who had unsuccessful treatment with a cytokine, the manufacturer provided two studies. Both studies compared axitinib with sorafenib. Data from 251 participants in the larger study and 103 participants in the smaller study was analyzed. Despite their advanced stage of cancer, the participants in both studies were in good general health and were able to go about their daily lives with minor limitations.

What are the advantages of axitinib?

  • Severe hand-foot syndrome: The studies suggest that this side effect was less common during treatment with axitinib than during the standard treatment with sorafenib. Hand-foot syndrome is characterized by painful reddening and swelling of the palms of the hands and the soles of the feet. In severe cases it can be quite unpleasant.
  • Hair loss and rash: Here too, the studies indicated that these side effects are less common during treatment with axitinib than during the standard treatment.

What are the disadvantages of axitinib?

  • Severe tiredness (fatigue) and underactive thyroid: The results of the studies suggest that axitinib may possibly have a disadvantage here when compared with sorafenib. These symptoms were more common during treatment with axitinib than during the standard treatment.
  • Dysphonia: The studies indicated that dysphonia was more common during treatment with axitinib than during standard treatment with sorafenib. Dysphonia is a problem affecting your voice, making it hoarse or husky, for instance.

No difference

The studies found no differences between the treatments in terms of the following:

  • Life expectancy
  • Symptoms of the disease
  • General health
  • Other severe side effects

What remains unanswered?

  • Health-related quality of life: The manufacturer didn’t provide any suitable data regarding quality of life.
  • Treatment stopped due to side effects: The manufacturer didn’t provide any suitable data here either.

More information

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

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