Ramucirumab (Cyramza) for men with metastatic bowel cancer
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ramucirumab in people with metastatic bowel cancer. The drug manufacturer provided IQWiG with one relevant study involving 615 men. About half of them were given ramucirumab and FOLFIRI, while the rest had treatment with FOLFIRI only.
What are the advantages of ramucirumab?
For men, taking ramucirumab in addition to FOLFIRI did not offer any advantages.
What are the disadvantages of ramucirumab?
- Severe side effects: There was weak evidence for a disadvantage in terms of severe side effects. 79 out of 100 men who received ramucirumab and FOLFIRI had severe side effects, compared with 62 out of 100 men who received FOLFIRI alone.
- Treatment stopped due to side effects: Here too, there was weak evidence for a disadvantage. 29 out of 100 participants who had ramucirumab combined with FOLFIRI stopped their treatment due to side effects, while 13 out of 100 participants did the same in the comparison group.
- There was also weak evidence for a disadvantage in terms of loss of appetite and constipation 69 out of 100 men who were given ramucirumab and FOLFIRI reported loss of appetite. In the comparison group, 48 out of 100 men experienced this side effect. 51 out of 100 men who had ramucirumab and FOLFIRI reported constipation, compared with 39 out of 100 men from the comparison group.
- Other side effects: Bleeding, headache, hand-foot syndrome and edema were more common in people who had treatment with ramucirumab and FOLFIRI.
- Overall health and quality of life: There was weak evidence of a disadvantage in terms of self-reported overall health. The same was true for several aspects of quality of life, such as physical, social and emotional functioning.
No difference
- Life expectancy: There was no difference here in men. In both groups, half the participants had passed away within about 12 to 14 months.
- Fatigue: There was no relevant difference here either. About 65 to 74 out of 100 people experienced fatigue.
- Diarrhea, shortness of breath, insomnia, nausea and vomiting: About 42 to 54 out of 100 participants had these side effects, with no discernible differences between the groups.
- Quality of life: There were no differences between groups in the quality-of-life subcategories "cognitive functioning" and "social functioning".
Sources
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 A16-10. Cologne: IQWiG. May 30, 2016.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ramucirumab (colorectal cancer) - Addendum to Commission A16-10. Commission A16-50. Cologne: IQWiG. July 27, 2016.
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