BIOMARKER Russian patent published in 2010 - IPC C12Q1/68 A61K31/00 A61P35/00 

FIELD: medicine.

SUBSTANCE: invention describes a biomarker intended for determining sensitivity of proliferative diseases, such as cancer, to mTORs inhibitor combined with a cytotoxic agent, first of all with a cytotoxic agent (CA) that damages or disturb DNA integrity. According to the invention, the biomarker designated as p21 represents cip/kip-family of cyclinkinase inhibitors. Sensitivity or response of the proliferative disease in an individual on treatment with mTOR inhibitor combined with CA is determined by the level of p21 expression after CA treatment and a combination therapy with using CA and mTOR inhibitor. Favorable treatment and sensitivity of disease to the combination therapy is predicted by the absence of expression induction reduced. Besides according to the invention, the biomarker can be used in the method to overcome the CA resistance in the patient treated with CA. That is ensured by evaluating p21 level in a sample, the increasing regulation of p21 expression following CA introduction to the patient, mTOR inhibitor is administered in combination with CA, while lowered expression regulation observed following the combination therapy ensures to continue treatment with mTOR inhibitor with simultaneous or consecutive CA introduction.

EFFECT: application of the invention allows for more accurate prediction of sensitivity of a proliferative diseases in an individual to the combination therapeutic treatment.

4 cl, 5 ex