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We previously reported a phase  II  study of a cancer vaccine using five novel peptides recognized by   HLA ‐A*2402 ‐restricted  CTL  in combination with oxaliplatin‐containing chemotherapy ( FXV  study) as first‐line therapy for patients with metastatic colorectal cancer and demonstrated the safety and promising potential of our five‐peptide cocktail. The objective of this analysis was to identify predictive biomarkers for identifying patients who are likely to receive a clinical benefit from immunochemotherapy. Circulating cell‐free  DNA  (cf DNA ) in plasma has been reported to be a candidate molecular biomarker for the efficacy of anticancer therapy. Unlike uniformly truncated small‐sized  DNA  released from apoptotic normal cells,  DNA  released from necrotic cancer cells varies in size. The integrity of plasma cf DNA  (i.e. the ratio of longer fragments [400 bp] to shorter fragments [100 bp] of cf DNA ), may be clinically useful for detecting colorectal cancer progression. We assessed plasma samples collected from 93 patients prior to receiving immunochemotherapy. The cf DNA  levels and integrity were analyzed by semi‐quantitative real‐time  PCR . Progression‐free survival was significantly better in patients with a low plasma cf DNA  integrity value than in those with a high value ( P  = 0.0027). Surprisingly, in the   HLA ‐A*2402 ‐matched group, patients with a low plasma cf DNA  integrity value had significantly better progression‐free survival than those with a high value ( P  = 0.0015). This difference was not observed in the   HLA ‐A*2402 ‐unmatched group. In conclusion, the integrity of plasma cf DNA  may provide important clinical information and may be a useful predictive biomarker of the outcome of immunotherapy in metastatic colorectal cancer.

Prediction of the efficacy of immunotherapy by measuring the integrity of cell‐free DNA in plasma in colorectal cancer