The drug aflibercept (trade name: Zaltrap) has been approved in Germany since February 2013 in combination with a certain chemotherapy for adults with metastatic colorectal cancer in whom chemotherapy with oxaliplatin could not stop the disease from progressing. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG) the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the current standard therapy. According to this, considerable advantages in respect of overall survival are accompanied by major potential harm in the form of side effects. Overall, there is therefore an indication of a minor added benefit of aflibercept.
Aflibercept complements chemotherapy
Aflibercept in combination with a chemotherapy consisting of irinotecan/5-fluorouracil/folinic acid (FOLFIRI) was compared with FOLFIRI alone. The approval study (VELOUR), which compared the treatment "aflibercept plus FOLFIRI" with the treatment "placebo plus FOLFIRI", was available for the benefit assessment. This was a randomized and double-blind study, i.e. the patients were assigned randomly to one of the two treatment groups, and neither the patients nor the doctors knew whether aflibercept with FOLFIRI or FOLFIRI alone was used.
A total of 178 centres in Europe, America, Australia, New Zealand, South Africa and Korea took part in this multinational study: The participants were 1226 adults with adenocarcinoma of the colon or rectum who had recurrence after failure of a chemotherapy containing the drug oxaliplatin.
Overall survival: indication of considerable added benefit
Half of the patients who received FOLFIRI chemotherapy alone had died after 12 months. Half of the patients who received aflibercept in combination with FOLFIRI chemotherapy had died after 13 to 14 months. This means that life expectancy increas
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