Gemcitabine and capecitabine for heavily pre-treated metastatic colorectal cancer patients--a phase II and translational research study.

摘要: AIM We investigated the efficacy and safety of capecitabine gemcitabin (GemCap) in heavily pre-treated, therapy-resistant metastatic colorectal cancer (mCRC) patients clinical importance cell-free DNA (cfDNA) measurement. PATIENTS AND METHODS Patients' inclusion criteria included histopathologically-verified mCRC refractory to standard chemotherapy, adequate organ function performance status. Treatment (2,000 mg/m(2) day on days 1-7 q2w) gemcitabine (1,000 1). The number alleles was measured pre-treatment plasma samples using an in-house developed qPCR. RESULTS Forty-nine were study. GemCap well-tolerated majority patients. Disease control rate 30%, median progression-free survival (PFS) overall (OS) by intention-to-treat 2.7 (95%CI=2.6-2.8) 6.8 (95%CI=5.0-7.7) months. Median OS with cfDNA concentrations above (13,200 alleles/ml) 4.7 (3.7-9.6) months compared 7.8 remaining (HR=2.22; 1.07-3.9; p=0.0186). prognostic value confirmed multivariate analysis. CONCLUSION encouraging efficacy, shown hold a strong value.