EGFR Blood Monitoring

Abstract

Improved methods of assessing status of a solid-tumor cancer in a subject involving detection of tumor-associated mutations in the subject's blood.

1 . A method of identifying a candidate non-small cancer cell lung cancer (NSCLC) patient for a targeted drug therapy, comprising:
 detecting presence or absence of one or more mutated Epidermal Growth Factor Receptor (EGFR) sequence in blood from the patient;   assessing metastatic status of the NSCLC patient as M1a or M1b; and,   identifying the patient as a candidate for the targeted drug therapy based on at least the detected presence of the one or more mutated EGFR sequence in the blood of the patient, and the metastatic status of NSCLC in the patient.   
     
     
         2 . The method of  claim 1 , wherein the one or more mutated EGFR sequence comprises an activating EGFR mutation. 
     
     
         3 . The method of  claim 2 , wherein the activating EGFR mutation is selected from the group consisting of an exon 19 deletion, L858R, L861Q and G719X 
     
     
         4 . The method of  claim 1 , wherein the one or more mutated EGFR sequence comprises a resistance EGFR mutation. 
     
     
         5 . The method of  claim 4 , wherein the resistance EGFR mutation is selected from the group consisting of T790M, S678I and an exon 20 insertion. 
     
     
         6 . The method of  claim 1 , wherein the detecting comprises testing the blood from the patient for the one or more mutated EGFR sequence by an analytical technique. 
     
     
         7 . The method of  claim 1 , wherein the targeted drug therapy is a tyrosine kinase inhibitor. 
     
     
         8 . The method of  claim 7 , wherein the tyrosine kinase inhibitor is erlotinib of gefitinib. 
     
     
         9 . The method of  claim 1 , wherein the assessed metastatic status of the patient as M1a. 
     
     
         10 . The method of  claim 9 , wherein the identifying further comprises detecting presence or absence of one or more mutated EGFR sequence in a tumor tissue of the patient with the metastatic status M1a if the absence of the at least one of the one or more mutated EGFR sequence in the blood of the patient is detected. 
     
     
         11 . The method of  claim 1 , wherein the assessed metastatic status of the NSCLC patient is M1b. 
     
     
         12 . The method of  claim 11 , wherein the identifying comprises identifying the NSCLC patient with the metastatic status M1b as the candidate for the targeted drug therapy if the presence of the at least one of the one or more mutated EGFR sequence in the blood of the patient is detected. 
     
     
         13 . The method of  claim 12 , wherein the assessing comprises administering a targeted drug therapy to the subject if the presence of the at least one of the one or more mutated EGFR nucleic acid sequence in the blood of the subject is detected. 
     
     
         14 . The method of  claim 1 , wherein the assessing comprises administering a targeted drug therapy to the subject if the presence of the at least one of the one or more mutated EGFR nucleic acid sequence in the blood of the subject is detected. 
     
     
         15 . The method of  claim 14 , wherein the at least one or more mutated EGFR sequence contains an activating EGFR mutation and the targeted drug therapy is a tyrosine kinase inhibitor. 
     
     
         16 . The method of  claim 1 , wherein the detecting comprises detecting one or more times the presence or absence of one or more mutated EGFR sequence in the blood of the subject before, during, or after targeted drug therapy, or any combination thereof. 
     
     
         17 . The method of  claim 16 , wherein the presence of at least one or more mutated EGFR sequence containing an activating EGFR mutation is detected and the assessing further comprises increasing a dose of a tyrosine kinase inhibitor administered to the patient if an increase in quantity of the mutated EGFR sequence is detected. 
     
     
         18 . The method of  claim 1 , wherein the assessing comprises modifying the targeted drug therapy if presence of a resistance EGFR mutation is detected. 
     
     
         19 . The method of  claim 1 , wherein the detecting comprises detecting the presence or the absence of the one or more mutated EGFR sequence in the blood of the NSCLC patient before, during, or after chemotherapy, before or after surgery or any combination thereof. 
     
     
         20 . A method of assessing status of a subject with a solid tumor cancer, comprising:
 detecting presence or absence of one or more tumor-associated mutated nucleic acid sequence in blood from the subject with the solid tumor cancer; and,   assessing the status of the subject with distant metastasis solid tumor cancer based on the detected presence or absence of the one or more mutated tumor-associated nucleic acid sequence.   
     
     
         21 . The method of  claim 20 , wherein the assessing comprises administering a targeted drug therapy to the subject if the presence of the at least one of the one or more mutated tumor-associated nucleic acid sequence in the blood of the subject is detected. 
     
     
         22 . The method of  claim 21 , wherein the at least one or more mutated oncogene sequence contains an activating mutation and the targeted drug therapy is a tyrosine kinase inhibitor.