Novel antitumoral use of cabazitaxel

Abstract

The invention relates to a compound of formula:which may be in base form or in the form of a hydrate or a solvate, in combination with prednisone or prednisolone, for its use as a medicament in the treatment of prostate cancer, particularly metastatic prostate cancer, especially for patients who are not catered for by a taxane-based treatment.

What is claimed is: 
     
         1 . A method for treating prostate cancer in a patient in need thereof comprising administering to said patient a compound of formula 
       
         
           
           
               
               
           
         
         which may be in base form or in the form of a hydrate or a solvate, 
         in combination with prednisone or prednisolone. 
       
     
     
         2 . The method according to  claim 1 , where the treated patients are not catered for by a taxane-based treatment. 
     
     
         3 . The method according to  claim 1 , where the patients treated have been previously treated with a docetaxel-based regimen. 
     
     
         4 . The method according to  claim 1 , where the prostate cancer is an advanced metastatic disease. 
     
     
         5 . The method according to  claim 1 , where the prostate cancer is a castration resistant prostate cancer or hormone-refractory prostate cancer. 
     
     
         6 . The method according to  claim 1 , where the compound is in the form of an acetone solvate. 
     
     
         7 . The method according to  claim 6 , in which the acetone solvate contains between 5% and 8% by weight of acetone. 
     
     
         8 . The method according to  claim 1 , where the compound is administered at a dose of between 15 and 25 mg/m 2 , the prednisone or prednisolone being administered at a dose of 10 mg/day. 
     
     
         9 . The method according to  claim 8 , where the compound is administered at a dose of 25 mg/m 2 . 
     
     
         10 . The method according to  claim 1 , comprising repeating the administration of such compound as a new cycle every 3 weeks. 
     
     
         11 . The method according to  claim 10 , wherein the median number of cycles is 6. 
     
     
         12 . The method according to  claim 1 , where the compound is administered in combination with prednisone for the treatment of patients with castration resistant metastatic prostate cancer or hormone-refractory prostate cancer and who have been previously treated with docetaxel based regimen. 
     
     
         13 . The method according to  claim 12 , where the compound is cabazitaxel. 
     
     
         14 . The method according to  claim 1 , wherein said compound is administered in an amount to provide an AUC of about 991 ng·h/mL (CV 34%). 
     
     
         15 . The method according to  claim 1 , wherein said compound is administered in an amount to provide an C max  of about 226 ng·h/mL (CV 107%). 
     
     
         16 . The method according to  claim 1  wherein said compound is administered in an amount to provide a plasma clearance of 48.5 L/h (CV 39%). 
     
     
         17 . The method according to  claim 1 , further comprising monitoring blood counts and measuring neutrophil levels in the patient. 
     
     
         18 . The method according to  claim 17 , wherein said monitoring comprises taking a blood sample from the patient. 
     
     
         19 . The method according to  claim 18 , further comprising discontinuing cabazitaxel treatment in a patient with a neutrophil count of ≤1,500 cells/mm 3 . 
     
     
         20 . A method of reducing the risk of a severe hypersensitivity reaction in a patient with prostate cancer being treated with a compound as defined in  claim 1  comprising administering to the patient a medication to prevent hypersensitivity prior to the administration of cabazitaxel. 
     
     
         21 . A method of increasing the survival of a patient with hormone refractory metastatic prostate cancer, comprising administering a clinically proven effective amount of a compound as defined in  claim 1  to the patient in combination with prednisone or prednisolone.