Afatinib (trade name: Giotrif) has been approved in Germany since September 2013 for the treatment of a specific type of advanced lung cancer. It can be used in adult patients who have mutated cancer cells that can lead to faster tumor growth.
Lung cancer is caused by malignant cell growth in the bronchi and the bronchioles, the thinner branches of the bronchi. That is why this kind of cancer is also called bronchial carcinoma. There are two main types of tumors:
- Small cell lung carcinoma (SCLC)
- Non-small cell lung carcinoma (NSCLC)
Non-small cell lung cancer is removed surgically if possible. But sometimes it has already become too large, or it may have spread to other parts of the body though the bloodstream or via lymph vessels. If this has happened, the cancer is considered to be advanced lung cancer.
Some people with non-small-cell lung cancer have an abnormal protein in the tumor tissue, called epidermal growth factor receptor (EGFR). The mutated receptor can lead to uncontrolled growth of the tumor. It can appear in different types (mutations). The two main mutations are “Del19 “and “L858R mutation.” Afatinib aims to block the mutated receptor, thereby preventing further tumor growth.
Afatinib is taken once a day as tablet (40 mg). Patients should not eat anything three hours prior to taking it and one hour after. The dosage depends on how well the patient tolerates the drug and on possible side effects, and can be changed individually. Treatment is terminated if the disease progresses or if serious side effects arise.
Depending on their state of health and prior treatments, patients with advanced lung cancer can receive a conventional treatment with gefitinib, erlotinib, gemcitabine, or a combination of cisplatin and a second cytostatic drug.
In the beginning of 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the benefits of afatinib in adults with advanced lung cancer and a mutated EGF receptor. The drug manufacturer provided IQWiG with a relevant study in which one patient group received treatment with afatinib and a second group received treatment with a combination of cisplatin and pemetrexed.
The study shows that the results of treatment with afatinib also depend on the mutations of the tumor. Therefore, results have been classified according to the following mutations:
- Del19 EGFR mutation
- L858R EGFR mutation
- Other EGFR mutations
What remains unanswered?
It is unclear if afatinib has additional benefits for patients who have been treated with chemotherapy before. The manufacturer did not provide any data for this case.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The IQWiG 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, G-BA passed a resolution on the added benefit of afatinib (Giotrif).
General information on possible side effects of afatinib can be found on the package insert.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Afatinib - Benefit assessment according to § 35a Social Code Book V. Dossier assessment A13-41. Cologne: IQWiG. February 17, 2014.
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