Introduction

The fixed-dose combination of the drugs netupitant and palonosetron (trade name: Akynzeo) has been approved in Germany since May 2015 for use in adults who are receiving chemotherapy for the treatment of cancer. The combination netupitant / palonosetron is used to prevent nausea and vomiting. It is an option for:

  • people who are having chemotherapy, which causes nausea in many patients, and for
  • people who are having chemotherapy with the drug cisplatin, which causes nausea in almost all patients.

Chemotherapy aims to stop the growth of cancer cells, but the drugs that are used also affect healthy cells. This can cause side effects such as hair loss, anemia, nausea, vomiting and diarrhea.

If chemotherapy affects the part of the brain that controls vomiting, leading to nausea and vomiting, it is called emetogenic chemotherapy. Nausea and vomiting may be acute and arise within 24 hours of chemotherapy, or it may be delayed and only start 24 hours later.

Netupitant and palonosetron work in different ways to prevent nausea and vomiting: Palonosetron is a serotonin receptor antagonist. It counteracts acute nausea in the gastrointestinal system. Netupitant, a neurokinin-1 receptor antagonist, affects the central and peripheral nervous systems. Both drugs inhibit the effect of chemical messengers on the "vomiting center" in the brain.

Application

The combination netupitant / palonosetron is taken in the form of a capsule about an hour before the start of each course of chemotherapy. One capsule contains 300 mg of netupitant and 0.5 mg of palonosetron.

If the steroid dexamethasone is taken at the same time, only half of that dose should  be taken.

Other treatments

Different standard therapies for preventing nausea and vomiting are available for patients who are having chemotherapy. The options depend on what type of chemotherapy is used.

  • Patients receiving chemotherapy that causes nausea in many patients can combine a serotonin receptor antagonist and dexamethasone.
  • Patients receiving chemotherapy that causes nausea in almost all patients can have triple therapy with a serotonin receptor antagonist, a neurokinin-1 receptor antagonist and dexamethasone.

Assessment

In 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether the fixed-dose combination of netupitant and palonosetron has any advantages or disadvantages compared with the standard therapies for nausea and vomiting.

The manufacturer did not provide any suitable data on people having chemotherapy that often causes nausea. This means that it is not possible to tell whether the combination netupitant / palonosetron has any advantages or disadvantages compared with standard therapies in this group of people.

The manufacturer provided one suitable study involving people receiving chemotherapy that causes nausea in nearly all patients. The data of 100 participants could be used in the analysis: 74 people received the fixed combination netupitant / palonosetron and 26 people had triple therapy with palonosetron (serotonin receptor antagonist), aprepitant (neurokinin-1 receptor antagonist) and dexamethasone. The results of this study are described below.

No difference

  • Life expectancy: The researchers did not find any differences between netupitant / palonosetron and the standard therapy here.
  • Side effects: In terms of side effects or the discontinuation of treatment due to side effects, the study did not show any significant differences between the treatments.

What remains unanswered?

  • Nausea and vomiting: The study did not provide suitable data about how the fixed-dose combination of netupitant and palonosetron compares with standard therapy.
  • Quality of life: The study did not look into effects on quality of life.

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 this review and hearings received G-BA passed a resolution on the added benefit of the fixed combination netupitant / palonosetron (Akynzeo) .

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