Patent ID: 8748108

Claim:
A method for classifying a patient having cancer as a candidate for therapy with a Bcl-2 family inhibitor comprising: (a) providing a tissue, blood, plasma or serum sample from a patient; (b) determining the level of (i) plasma pro-gastrin releasing peptide (proGRP), (ii) cytokeratin 19 fragment antigen 21-1 (CYFRA 21-1), (iii) neuron-specific enolase (NSE), (iv) circulating tumor cell (CTC) number, and (v) Bcl-2 gene copy number in the tissue, blood, plasma or serum sample; (c) classifying the patient as a candidate for therapy with the Bcl-2 family inhibitor when the tissue, blood, plasma or serum sample is determined as having an increased level, relative to a threshold level, of (i) plasma pro-gastrin releasing peptide (pro-GRP) and (v) Bcl-2 gene copy number; and a decreased level, relative to a threshold level, of (ii) cytokeratin 19 fragment antigen 21-1 (CYFRA 21-1), (iii) neuron-specific enolase (NSE), and (iv) circulating tumor cell (CTC) number; and (d) administering the Bcl-2 family inhibitor to the patient classified in step (c) as a candidate for therapy with the Bcl-2 family inhibitor, wherein the Bcl-2 family inhibitor is N-(4-(4-((2-(4-chlorophenyl)-5,5-dimethyl-1-cyclohex-1-en-1-yl)methyl)piperazin-1-yl)benzoyl)-4-(((1R)-3-(morpholin-4-yl)-1-((phenylsulfanyl)methyl-)propyl)amino)-3-((trifluoromethyl)sulfonyl)benzenesulfonamide(navitoclax), wherein (i) the plasma pro-GRP threshold level is about 600 pg/mL, (ii) the CYFRA 21-1 threshold level is about 2.3 ng/mL, (iii) the NSE threshold level is about 15 ng/mL, (iv) the CTC number threshold level is about 12 per 7.5 mL, and (v) Bcl-2 gene copy number is greater than 2.