Ramucirumab (trade name: Cyramza) has been approved in Germany since January 2016 for the treatment of advanced lung cancer. The drug is used in combination with docetaxel. It is a treatment option for adult patients with non-small cell lung carcinoma who have already had platinum-based chemotherapy.
Lung cancer is caused by the malignant growth of cells in the airways (bronchi). This is why it is also referred to as a bronchial carcinoma. There are two main types of tumors:
- Small cell lung carcinoma, SCLC
- Non-small cell lung carcinoma, NSCLC
NSCLC is surgically removed, if possible. But sometimes the tumor has already become too large or the cancer has spread to other parts of the body (metastasis) through the blood or lymphatic system. This is called advanced lung cancer.
The drug ramucirumab is an antibody which disrupts the growth of new blood vessels. This is believed to prevent the tumor from growing and stop the disease from progressing.
Ramucirumab should be taken before chemotherapy with docetaxel. The drug is given as an infusion (IV drip).
The infusion takes about 60 minutes and is given every three weeks. The dose is determined by the patient's body weight. Treatment is stopped if the cancer progresses or ramucirumab is no longer tolerated.
Patients with advanced non-small cell lung carcinoma who have already had platinum-based chemotherapy have various standard treatment options, such as the drugs docetaxel, pemetrexed, gefitinib, erlotinib, and crizotinib.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether people with advanced non-small cell lung carcinoma can benefit from treatment with ramucirumab.
The manufacturer provided two studies comparing docetaxel with a combination of ramucirumab and docetaxel. The larger study involved 1,253 participants, the smaller one had 197 participants.
What are the advantages of ramucirumab?
- Life expectancy: There was an advantage for people under the age of 65. In the larger study, half of the people taking both ramucirumab and docetaxel had passed away after about 11 months, while half of the patients who received only docetaxel had passed away after 9 months. There was no difference between the two treatments in people over the age of 65.
What are the disadvantages of ramucirumab?
- Severe side effects: The studies provide weak evidence for a disadvantage here. 79 out of 100 people who took both ramucirumab and docetaxel had severe side effects. This was the case in 72 out of 100 people in the comparison group.
- Treatment stopped due to side effects: The studies showed a disadvantage for the combination of ramucirumab and docetaxel. In the larger study, about 9 out of 100 people who took the new drug stopped treatment, while only 5 out of 100 who took only docetaxel did the same.
- Lack of immune cells combined with fever: The studies showed a disadvantage for the treatment with ramucirumab here. A decrease in the number of granulocytes combined with fever was more common in the ramucirumab / docetaxel group than in the comparison group with docetaxel alone. In the larger study, this was the case in about 16 out of 100 people who took ramucirumab, and only in 10 out of 100 people who only took docetaxel.
- Inflammation of the mucous membranes lining the mouth: There is some evidence that inflammations of the mucous membranes lining the mouth are more common in people taking the combination ramucirumab / docetaxel than in people taking docetaxel alone.
- Bleeding: Regarding this side effect, there was weak evidence for a disadvantage in people who do not have squamous cell carcinoma: In the group taking ramucirumab and docetaxel this side effect was more common than in people taking docetaxel only. This difference was not obseved in people with squamous cell carcinoma.
- Increase in symptoms: The larger study did not show any differences between the treatments here.
- General health: There were no differences here either.
What remains unanswered?
- Health-related quality of life: The manufacturer did not provide any suitable data with which to answer this question.
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 ramucirumab (Cyramza).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ramucirumab (new therapeutic indication) - Benefit assessment according to §35a Social Code Book V. Dossier assessment A16-11. Cologne: IQWiG. May 30, 2016.
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
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