Oxaliplatin plus irinotecan vs irinotecan as second-line treatment in pancreatic cancer patients:a randomized–controlled open-label Phase II study

Background:Limited second-line therapeutic options are available for metastasis pancreatic cancer(mPC).We aimed to explore the efficacy and safety of oxaliplatin plus irinotecan(IROX)in mPC patients.Methods:This is an open-label,Phase 2,randomized study of mPC patients(aged 18–75 years)who failed when using gemcitabine plus S-1 as first-line therapy.Block randomization with a block size of four was used to randomly assign patients(1:1)between October 2015 and December 2017 to receive either IROX(oxaliplatin 85mg/m2 and irinotecan 160mg/m2)or irinotecan monotherapy(irinotecan 180mg/m^(2))until disease progression,unacceptable adverse events,or consent withdrawal.The primary end point was overall survival,and the secondary end points were progression-free survival,overall response rate,and adverse event rate.Results:A total of 74 patients were enrolled in this study,including 44 males and 30 females,with an average age of 61 years.The median overall survival was 10.2 and 6.7 months(adjusted hazard ratio[HR],0.7;95%confidence interval[CI],0.4–1.2;P=0.20)and the median progression-free survival was 5.1 and 2.3 months(adjusted HR,0.4;95%CI,0.2–0.6;P<0.01)in the IROX group and irinotecan group,respectively.The overall response rates were 18.4%(7/38)in the IROX group and 5.5%(2/36)in the irinotecan group(P=0.06).Grade 3–4 adverse events occurred in 34%(13/38)of patients in the IROX group and 19%(7/36)of patients in the irinotecan group(P=0.15).Conclusions:IROX had no significant survival benefit over irinotecan monotherapy in our study.However,IROX reduced the risk of disease progression by 60%,with acceptable toxicity.