Methods for prediction and prognosis of cancer, and monitoring cancer therapy

A method to monitor the response of a patient being treated for renal cell carcinoma by administering sorafenib, comprising:

• (a) determining the level of expression of the biomarker VEGF and/or sVEGFR-2 in a first plasma sample taken from the patient prior to treatment with sorafenib;
• (b) determining the level of expression of VEGF and/or sVEGFR-2 in at least a second plasma sample taken from the patient subsequent to the initial treatment with sorafenib;
• and
• (c) comparing the level of expression of the VEGF and/or sVEGFR-2 in the second sample with the level of expression of the biomarker in the first sample;
• wherein a change in the level of expression of the VEGF and/or sVEGFR-2 in the second sample compared to the level of expression of said VEGF and/or sVEGFR-2 in the first sample indicates the effectiveness of the treatment with sorafenib.

A method for evaluating the condition of a patient with cancer comprising:

• a. determining the level of expression of VEGF and/or sVEGFR-2 from a biological sample taken from a patient;
• b. comparing the level of expression of VEGF and/or sVEGFR-2 and sample with one or more of the following
• i) levels in a similar sample taken from one or more subjects not suspected of having cancer,
• ii) levels in a similar sample take from one or more subjects suspected of having cancer, or
• iii) levels in a similar sample taken from the patient at another time, wherein the difference in the level of expression of VEGF and/or sVEGFR-2 in the sample (a) and the one or more comparisons correlates with the condition of the patient with respect to the disease state and/or expected changes in the disease state.

A method for monitoring the response of a patient being treated for solid tumors with the compound N-[4-chloro-3-(trifluoromethyl)phenyl]-N′-{4-[2-carbamoyl-1-oxo-(4-pyridyloxy)]phenyl}urea of the formula I below or pharmaceutically acceptable salt, polymorph, hydrate, solvate or combination thereof

• comprising:
• a) determining the level of expression of VEGF and/or sVEGFR-2 in a biological sample obtained from a patient;
• b) determining the level of expression of VEGF and/or sVEGFR-2 in at least a second biological sample taken from the patient subsequent to the initial treatment with the compound of formula I or a pharmaceutically acceptable salt, polymorph, hydrate, solvate or combination thereof, and
• c) comparing the level of expression of VEGF and/or sVEGFR-2 in the second sample with the level of expression of VEGR and/or sVEGFR-2 in the first sample;
• wherein the change in level of expression of VEGF and/or sVEGFR-2 in the second sample compared to the level of expression of said VEGF and/or sVEGFR-2 in the first sample indicates the effectiveness in the treatment with the compound of formula I or a pharmaceutically acceptable salt, polymorph, hydrate, solvate or combination thereof.