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Background:  The research on circulating tumor DNA (ctDNA) in pancreatic cancer (PC) has emerged recently. Although the detection rate of the  KRAS  mutation in ctDNA was relatively consistent with that in tumor tissue, whether the  KRAS  mutant allele fraction (MAF) differed was still not reported. So far, the clinical application of ctDNA detection in PC remains inconclusive.   Methods:  Plasma samples were collected from 110 PC and 52 pancreatic benign (PB) disease patients. The detection of  KRAS  mutation in ctDNA was performed using droplet digital PCR and compared with that in matched tumor tissue. We assessed the utility of  KRAS  MAFs in ctDNA and tissue for pancreatic malignancy assessment.   Results:  We found that  KRAS  MAF in ctDNA of PC patients was higher than that of PB patients, and was obviously associated with tumor staging and distant metastasis. However,  KRAS  MAF in ctDNA was significantly different from that in matched tissue.  KRAS  MAF in tumor tissue had no significant correlation with the clinical status. In addition, a ROC curve analysis revealed that mutant  KRAS  ctDNA combined with CA19-9 could increase the sensitivity rate of early-stage PC prediction, compared with CA19-9 test alone.   Conclusion:  The MAF of  KRAS  in ctDNA was related to the clinical stage of PC ( p  = 0.001). Mutant  KRAS  ctDNA could improve the sensitivity in early diagnosis of PC as a complement to CA19-9. Our study suggested that  KRAS  mutation in ctDNA could be a valuable circulating biomarker for the malignancy assessment in PC.

KRAS Mutant Allele Fraction in Circulating Cell-Free DNA Correlates With Clinical Stage in Pancreatic Cancer Patients