An additional benefit from a recently approved lung cancer drug is dependent on the severity of the disease, according to an evaluation by the German Institute for Quality and Efficiency in Health Care.
Nintedanib (Vargatef) was approved in November 2014 to be used in combination with docetaxel for the treatment of advanced non-small cell lung cancer of the glandular tissue in patients who received prior chemotherapy. The researchers noted a minor additional benefit of the combination therapy in patients who did not have brain metastases. In these patients, however, nintedanib showed more disadvantages than chemotherapy with docetaxel alone.
The manufacturer compared nintedanib plus docetaxel with placebo plus docetaxel. The observation duration in the nintedanib arm was a median of 4.3 months compared with 3 months in the placebo arm. As a result of the differing time periods, the results were uncertain for all outcomes aside from overall survival.
The data showed that the advantage or disadvantage of nintedanib in combination with docetaxel is primarily dependent on whether patients had brain metastases at the start of the study. In patients without brain metastases who received nintedanib in combination with docetaxel, overall survival was a median of 13.5 months versus 10.3 months in the placebo arm, which indicates a minor additional benefit from nintedanib.
Diarrhea was more frequent in the nintedanib arm, but this adverse event did not challenge the survival advantage. In patients treated with nintedanib who had brain metastases at the start of the study, a loss of appetite was found more frequently. Additionally, nausea, vomiting, and diarrhea became worse during the treatment, which indicated a lesser benefit from nintedanib in patients with brain metastases.