Comparing efficacy and safety of regorafenib versus pemetrexed in lung cancer: A preliminary clinical trial evaluating effect of inflammatory biomarkers on disease progression.

ABSTRACT

This pilot clinical trial was designed to compare the efficacy and safety of regorafenib versus pemetrexed in Chinese patients with early stage of lung cancer. Also, the effect of inflammatory biomarkers on disease progression among Lung cancer patients who received regorafenib versus pemetrexed was evaluated in the present study. The patients who were diagnosed with early stage of lung cancer were enrolled. The eligible participants were randomized to receive regorafenib 160 mg (orally once daily for the first 21 days of each 28-day cycle) plus BSC or pemetrexed 500 mg/m2 intravenously (Day 1 of each 21-day cycle in combination with cisplatin 75 mg/m2 i.v. beginning 30 minutes after pemetrexed administration) plus BSC in a 11 ratio. Efficacy measures such as overall survival, progression-free survival and overall response were assessed after regorafenib and pemetrexed treatment. Safety of after regorafenib and pemetrexed treatment was also assessed. Blood was collected into a test tube pre-washed with chilled EDTA tubes, and then centrifuged to collect plasma sample for estimation of inflammatory biomarkers of interest. Survival time in respect to disease progression was also assessed. Also, biomarker assessments were made at each visit, to see whether inflammatory biomarker has any specific role on survival or in predicting progression of lung cancer. The present study results show that the safety and efficacy profile of regorafenib and pemetrexed was found similar in Chinese patients with early stage lung cancer. In general, regorafenib and pemetrexed treatment was well tolerated in Chinese patients with early stage Lung cancer. The results of this pilot study showed that inflammatory biomarkers such as interleukin 6 and interleukin 17A play an important role predicting progression of early stage lung cancer among Chinese patients.