Autologous Cytokine-Induced Killer Cells Improves Overall Survival of Metastatic Colorectal Cancer Patients: Results From a Phase II Clinical Trial

Abstract

BackgroundThis randomized clinical study was conducted to evaluate the therapeutic benefits of cytokine-induced killer (CIK) cell immunotherapy in combination with chemotherapy in metastatic colorectal cancer (mCRC) patients. Patients and MethodsSixty-one patients in group 1 (cell therapy group) received autologous CIK cell immunotherapy in combination with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan). Another 61 patients in group 2 (the control group) received chemotherapy (FOLFOX4 plan) alone. The primary study end points were overall survival (OS) and progression-free survival (PFS). The secondary end points were treatment response and adverse events. ResultsThe 3-year PFS and OS in group 1 were 20% and 48%, respectively, compared with 13% and 23%, respectively, in group 2 (P = .131 and P < .001, respectively). The median OS in group 1 was significantly increased compared with that in group 2 (OS, 36 vs. 16 months; P < .001). Furthermore, there was a trend toward superior PFS in group 1 compared with that in group 2 (PFS, 16 vs. 10 months; P = .072). Using univariate analysis, we found that Karnofsky performance status <80, number of metastases >1, and increased platelet levels were significantly associated with poorer prognosis in group 1. Alternatively, the cycle count of CIK cell treatment was significantly associated with good prognosis in group 1. Toxicity was mild in patients who received CIK therapy. ConclusionThis study shows that CIK cell immunotherapy in combination with chemotherapy is well tolerated and improves the OS of mCRC patients.