In late November 2014 nintedanib, commercialized under the trade mark Vargatef, was approved to be used in combination with docetaxel to address the treatment of adults suffering with advanced non-small cell lung cancer (NSCLC) of the glandular tissue (adenocarcinoma) who had been previously treated with chemotherapy. The German Institute for Quality and Efficiency in Health Care (IQWiG) assessed a dossier to clear whether this new drug offers extra benefits.
This assessment concluded there is a minor extra benefit associated with the use of nintedanib when used in combination with docetaxel in individuals without brain metastases. Nevertheless, in those patients suffering from brain metastases, nintedanib has more disadvantages than using docetaxel alone.
The study compared treatment with nintedanib plus docetaxel to treatment with placebo plus docetaxel. Since the periods of treatment in both arms differed the results could be considered uncertain for all outcomes. According to the data, the advantages or disadvantages of nintedanib administered in combination with docetaxel highly depend if patients already have brain metastases at the beginning of the study.
Subjects without any brain metastases who received nintedanib in combination with docetaxel lived longer than the patients who only received treatment with docetaxel (median: 13.5 versus 10.3 months). This outcome provided an indication of a minor added benefit of nintedanib. As a toxic side effect, diarrhea was more frequent in individuals treated with nintedanib, however this disadvantage does not represent a challenge when it comes to the survival advantage it represents. Thus, an overall an indication of this combination treatment for patients without brain metastases remains.
When patients already presented brain metastases upon nintedanib administration, toxicity’s such as loss of appetite, nausea, vomiting and diarrhoea occurred and got worse during the treatment.
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The study, published in The Lancet journal, was conducted as part of a multi-year, phase 3 clinical trial that included UCLA researchers and several centers in 26 countries within 6 continents. This was a pioneer project that demonstrated Cyramza extended the survival of patients suffering with NSCLC.
