Background: The presence of mutated KRAS (mutKRAS ctDNA) in plasma samples has been consistently shown to be a negative prognostic indicator in pancreatic cancer (PC). Only small pilot studies have evaluated the value of serial mutKRAS ctDNA-measurements in PC.
Patients and methods: We used the BEAMing technology to determine levels of mutKRAS ctDNA, CA 19-9, CEA and CYFRA 21-1 in 284 plasma samples of 54 patients with advanced PC receiving gemcitabine-based chemotherapy. Absolute levels and kinetics of mutKRAS ctDNA, CA-19-9, CEA and CYFRA 21-1 were correlated to radiological response, progression free- and overall survival.
Results: mutKRAS ctDNA was present in a majority of advanced PC patients (n=36/54, 67%) and indicated tissue KRAS mutation status with a high sensitivity (75%) and specificity (100%). Presence of mutKRAS ctDNA, as well as higher levels of CA 19-9, CEA and CYFRA 21-1 prior to initiation of first-line chemotherapy were significantly correlated to an adverse overall survival. During therapy, changes in mutKRAS ctDNA levels were more rapid and pronounced than changes in protein-based tumor markers. Early and complete decreases of mutKRAS ctDNA were an early indicator of response to therapy, while there was no significant correlation between kinetics of CA 19-9, CEA or CYFRA 21-1 and response to chemotherapy during the first four weeks of treatment. Repeated mutKRAS ctDNA measurements during follow-up appeared to be superior to protein-based tumor markers in detecting progressive disease (sensitivity: 83%, specificity: 100%). As in progressive patients, mutKRAS ctDNA often re-increased after a temporary decrease, appropriate time points for monitoring have to be chosen.
Conclusion: mutKRAS ctDNA kinetics appear to be a powerful and highly specific tool in early response prediction and therapy monitoring of advanced PC patients receiving chemotherapy. (Ann Oncol 2018; 29: 2348-2355)