Introduction

The drug crizotinib (trade name: Xalkori) has been approved in Germany for the treatment of advanced non-small-cell lung cancer in adults. It is an option for two groups of patients:

  • Patients who have a mutated anaplastic lymphoma kinase (ALK) enzyme in their tumor tissue. The full name of the cancer is then ALK-positive non-small-cell lung cancer.
  • Patients who have a mutated proto-oncogene tyrosine-protein kinase (ROS1) enzyme in their tumor tissue. The full name of the cancer is then ROS1-positive non-small-cell lung cancer.

These mutated enzymes cause uncontrolled tumor growth. Crizotinib is used to block the mutated enzymes, thereby inhibiting further tumor growth.

Crizotinib has been approved in Germany since October 2012 for people with ALK-positive non-small-cell lung cancer who have had a different treatment before. The drug has been approved for first-line treatment since November 2015. Crizotinib has been approved for the treatment of ROS1-positive non-small-cell lung cancer since August 2016.

Lung cancer is caused by the malignant growth of cells in the bronchi and their branches (bronchioles). It is also referred to as a bronchogenic carcinoma. There are two main types of tumors:

  • Small-cell lung cancer, SCLC
  • Non-small-cell lung cancer, NSCLC

NSCLC is surgically removed, if possible. But sometimes the tumor has already become too large, or the cancer may have spread to other parts of the body through the bloodstream or via lymph vessels. This is called advanced lung cancer.

Application

Crizotinib is taken twice a day in capsule form. One tablet contains either 200 or 250 mg of crizotinib. The daily dose depends on how well the drug is tolerated.

Other treatments

For people with advanced non-small-cell lung cancer who have not had treatment for it before, one first-line treatment option is a combination of cisplatin or carboplatin with a cytostatic drug (vinorelbine, gemcitabine, docetaxel, paclitaxel, or pemetrexed). Treatment with gemcitabine or vinorelbine is also possible.

For people who have already had a different treatment, a new course of chemotherapy with docetaxel or pemetrexed may be an option. If this is not the case, best supportive care (BSC) is an option. Supportive care should be tailored to individual needs, relieve symptoms such as pain, and improve quality of life.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of crizotinib for the groups of people mentioned above when compared with standard therapies.

No relevant data was available for the following groups:

  • People with ROS1-positive non-small-cell lung cancer
  • People with ALK-positive non-small-cell lung cancer who have not had treatment before
  • People with ALK-positive non-small-cell lung cancer who have had treatment before and who cannot have chemotherapy again

It is therefore not possible to tell whether crizotinib has any advantages or disadvantages for these groups when compared with standard therapies.

For people with ALK-positive non-small-cell lung cancer who have had treatment before and who can have chemotherapy again, the study showed the following results.

What advantages does crizotinib have?

  • Pain, coughing, breathing difficulties: The study suggests that crizotinib can delay the worsening of pain, coughing or breathing difficulties compared with chemotherapy using docetaxel or pemetrexed: In people who had chemotherapy, these symptoms worsened on average after one and a half months. In people who took crizotinib, it took about another four months before pain, coughing or breathing difficulties started to worsen.
  • Quality of life: Overall there was weak evidence that people who took crizotinib had a better quality of life than those who had chemotherapy.

No difference

  • Life expectancy: There was no difference here between crizotinib and chemotherapy using docetaxel or pemetrexed.

What remains unanswered?

  • Side effects: Almost all participants experienced side effects, regardless of whether they took crizotinib or had chemotherapy. There were also no differences in the total number of side effects or how often treatment was stopped because of them. Vision problems and gastrointestinal problems such as diarrhea, nausea, vomiting and constipation were more common in people who took crizotinib than in those who had chemotherapy. Serious side effects, some fatal, occurred in both treatment groups. But the manufacturer did not provide enough data to make a conclusive comparison.

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 these reviews and the hearings received, the G-BA passed a resolution on the added benefit of crizotinib (Xalkori).

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