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Background  Cell-free DNA (cfDNA) has arisen as an alternative target for evaluating somatic mutations in cancer. KRAS mutation status is critical for targeted therapy in colorectal adenocarcinoma (CRAC). We evaluated KRAS G12/G13  mutations in cfDNA extracted from serum and compared the results with KRAS G12/G13  mutations detected in tissue samples. We assessed the clinical significance of KRAS G12/G13  mutation in serum in regard to recurrence and metastasis of CRAC.    Methods  A total of 146 CRAC patients were enrolled, and KRAS G12/G13  mutations were evaluated in 146 pairs of serum and tissue samples. In addition, 35 pairs of primary and metastatic CRAC tissue samples were evaluated for KRAS G12/G13  mutational status.    Results  Detection of KRAS G12/13  mutation from serum and tissue had a 55% concordance rate, and serum detection had a sensitivity of 39.8%. Detection of the KRAS G12/13  mutation yielded a 14% discordance rate between primary and metastatic tissue. CRAC patients with mutant KRAS G12/13  mutation in serum but wild-type KRAS G12/13  in tissue had concurrent KRAS G12/13 -mutant metastatic tumors, indicating spatial genetic heterogeneity. Changes in serum KRAS G12/G13  mutation status during postoperative follow-up were associated with recurrence. Conclusion: Although serum detection of the KRAS G12/13  mutation cannot substitute for detection in tissue, serum testing can support the interpretation of a CRAC patient’s status in regard to concurrent metastasis. Dynamic changes in serum KRAS G12/13  mutation status during follow-up indicated that cfDNA from serum represents a potential source for monitoring recurrence in CRAC patients.

frontiers in oncology

Serum-Based KRASG12/G13 Mutation Detection Using Droplet Digital PCR: Clinical Implications and Limitations in Colorectal Adenocarcinoma With Tumor Heterogeneity