MMC/UFT/LV in refractory colorectal cancer: phase II study and analysis of predictive variables of progression

Background The treatment of refractory metastatic colorectal cancer (rmCRC) and the lack of predictive variables are matters of debate. Patients and methods We conducted a multicentre phase II trial assessing the disease control rate (DCR) of the combination of tegafur/uracil and mitomycin C in rmCRC. The number of previous lines of chemotherapy, carcinoembryonic antigen (CEA) levels, progression-free survival of the last chemotherapy regimen (PPFS), and the neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio at the time of study entry were evaluated as indicators of early progression. Results We enrolled 42 patients. The combination was well tolerated with a DCR of 26.2% and median overall survival of 6.9 months. Low CEA levels, PPFS >6 months and low NLR were significantly associated with better prognosis. Conclusion The study failed its primary endpoint. However, some putative indicators of early progressive patients have been described.